U.S. patent application number 15/245849 was filed with the patent office on 2016-12-15 for soft tissue preservation temporary (shell) immediate-implant abutment with biological active surface.
The applicant listed for this patent is BIOMET 3I, LLC. Invention is credited to Stephen J. Chu, Mark N. Hochman, Adam J. Mieleszko, Jocelyn Huiping Tan-Chu.
Application Number | 20160361143 15/245849 |
Document ID | / |
Family ID | 49477613 |
Filed Date | 2016-12-15 |
United States Patent
Application |
20160361143 |
Kind Code |
A1 |
Hochman; Mark N. ; et
al. |
December 15, 2016 |
SOFT TISSUE PRESERVATION TEMPORARY (SHELL) IMMEDIATE-IMPLANT
ABUTMENT WITH BIOLOGICAL ACTIVE SURFACE
Abstract
An immediate dental implant shell has outer, multiple zones for
engaging a soft tissue socket left immediately after tooth
extraction from a bone socket. The zones have combinations of
different biologic agents, macro- or micro-geometric, or micro- or
macro-morphology irregularities to better engage gingival sulcus,
junctional epithelium and dento-gingival fiber zones of the soft
tissue socket. The shell may also have various guide markings and
projections to aide drilling of the implant hole in the bone
socket. A dental implant is placed in the drilled implant hole
before or after the shell has been placed in the soft tissue
socket, and has an axis that is independent of the shell axis so
the shell and implant both sit in optimum positions in their
respective soft and bone sockets.
Inventors: |
Hochman; Mark N.; (Great
Neck, NY) ; Chu; Stephen J.; (New York, NY) ;
Tan-Chu; Jocelyn Huiping; (New York, NY) ; Mieleszko;
Adam J.; (Arveme, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BIOMET 3I, LLC |
Palm Beach Gardens |
FL |
US |
|
|
Family ID: |
49477613 |
Appl. No.: |
15/245849 |
Filed: |
August 24, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13928460 |
Jun 27, 2013 |
9452032 |
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15245849 |
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13655056 |
Oct 18, 2012 |
9089382 |
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13928460 |
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13356359 |
Jan 23, 2012 |
8425231 |
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13655056 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61C 2008/0046 20130101;
A61C 9/004 20130101; A61C 8/0077 20130101; A61C 8/0001 20130101;
A61B 6/14 20130101; A61C 8/0098 20130101; A61C 8/0006 20130101;
A61C 13/0004 20130101; A61B 2090/3966 20160201; A61C 8/0068
20130101; A61C 1/084 20130101; A61C 13/0003 20130101; A61C 8/008
20130101; A61C 13/0001 20130101 |
International
Class: |
A61C 8/00 20060101
A61C008/00; A61C 1/08 20060101 A61C001/08; A61C 9/00 20060101
A61C009/00; A61B 6/14 20060101 A61B006/14; A61C 13/00 20060101
A61C013/00; A61C 8/02 20060101 A61C008/02; A61C 13/107 20060101
A61C013/107 |
Claims
1. A soft tissue preserving, dental implant arrangement for use
immediately after a tooth has been extracted to leave a soft tissue
socket and a bone socket, the arrangement comprising: a hollow
dental implant shell having at least two outer zones for engaging a
soft tissue socket left immediately after tooth extraction from a
bone socket, the zones being at least two of a gingival sulcus
zone, a junctional epithelium zone and a dento-gingival fiber zone
of the soft tissue socket, the at least two zones have combinations
of at least two different biologic agents, macro- or
micro-geometric, or micro- or macro-morphology irregularities to
engage gingival sulcus, junctional epithelium and dento-gingival
fiber zones of the soft tissue socket.
2. The arrangement of claim 1, wherein each of the at least two
outer zones of the shell has a peak and valley contour arrangement
that parallels an upper coronal edge of the hollow shell, the peak
and valley contour being consistent with the zones of the soft
tissue socket found juxtaposing a natural tooth.
3. The arrangement of claim 1, wherein the shell has a plurality of
guide markings or projections to aide drilling of a implant hole in
the bone socket.
4. The arrangement of claim 1, comprising three outer zones of the
shell, the three outer zones comprising three distinct and separate
bands that follow a peak and valley circumferential contour of the
upper edge of the hollow shell, with a first band that has a smooth
outer surface, a second band with vertical and oblique microgrooves
textured surface and a third band with pitted and roughened
micro-texture outer surface. A lower outer edge that is
non-scalloped.
5. The arrangement of claim 1, comprising three outer zones of the
shell, the three outer zones comprising three distinct and separate
bands that follow a peak and valley circumferential contour of the
upper edge of the hollow shell, with a first band that has a smooth
outer surface, a second band with vertical and oblique microgrooves
textured surface and a third band with pitted and roughened
micro-texture outer surface. A lower outer edge that is
non-scalloped, the upper band measuring about 1 mm to 3 mm in
vertical height, the second band measuring about 0.25 mm to 1.35 mm
in vertical height and the third band measuring about 1 mm to 3 mm
in vertical height.
6. The arrangement of claim 1, where each zone has a different one
of a treatment for engaging a soft tissue socket that is left in
gingival tissue after a tooth has been extracted from a bone socket
under the gingival tissue, selected from the group consisting of:
biologic agent treatment; macro-geometric pattern; micro-geometric
pattern; micro-morphology surface irregularities; and
macro-morphology surface irregularities; the shell having a first
perimeter adapted for placement toward the bone socket and a second
perimeter adapted for placement adjacent an outer surface of the
gingival tissue around the soft-tissue socket, the first perimeter
being smaller than the second perimeter so that the shell tapers
outwardly from the first to the second perimeters, the second
perimeter being asymmetrically scalloped with opposite distal and
mesial peaks and opposite lingual and facial valleys between the
peaks, and the shell being sized for closely engaging against the
soft-tissue socket without gaps; a dental implant having an implant
axis and being adapted for placement in the bone socket; a
temporary post rigidly connected to and coaxial with the dental
implant, the temporary post extending in the interior volume of the
hollow shell; and a luting compound filling the interior volume
between the shell and the temporary post and setting solid for
fixing the shell to the dental implant with no other connection
between the shell and the implant so that the outer surface of the
shell engages against the soft-tissue socket without gaps and
without requiring alignment of the shell axis to the implant
axes.
7. A soft tissue preservation, dental implant arrangement for use
immediately a tooth has been extracted to leave a soft tissue
socket and a bone socket, the arrangement comprising a dental
implant shell having a plurality of guide markings spaced around
the shell or projection from the shell to aide drilling of a
implant hole in the bone socket.
8. The arrangement of claim 7, wherein the markings are of a
material that is more opaque to x-rays than the material of the
shell.
9. The arrangement of claim 7, wherein the markings are inner
surface marking on the inner surface of the shell.
10. The arrangement of claim 7, wherein the markings are outer
surface markings on the outer surface of the shell.
11. The arrangement of claim 7, wherein the markings are each a
post extending from the shell.
12. The arrangement of claim 7, wherein the markings are each a
post extending toward in inner hollow volume of the shell.
13. The arrangement of claim 7, wherein the markings are each a
post extending parallel to an axis of the shell.
14. The arrangement of claim 7, wherein the markings are each a
post extending in one direction and a top crossing piece extending
in a transverse direction.
15. A soft tissue preserving and drill guide dental implant method
for use immediately after a tooth has been extracted to leave a
soft tissue socket having a shape and a bone socket to be drilled
to receive an implant at an extraction site, the method comprising:
providing a hollow dental implant shell having an outer surface
conforming substantially to the shape of the soft tissue socket
left immediately after the tooth extraction from the bone socket,
the shell having a plurality of markings that are more opaque to
x-rays than the material of the shell; inserting the hollow dental
implant shell into the soft tissue socket left immediately after
the tooth extraction from a bone socket; taking at least one
radiographic (x-ray) image of the extraction site with the shell in
the soft tissue socket and the bone socket near the shell; using
the radiographic (x-ray) and visual inspection of the shell in the
soft tissue socket to guide drilling of a hole for receiving a
dental implant in the area of the bone socket; inserting a dental
implant into the drilled hole without mechanically connecting the
dental implant to the shell so that the shell stays seated in the
soft tissue socket without disturbing the shape and anatomy of the
soft tissue socket while the dental implant is seated in the
hole.
16. The method of claim 15, wherein the markings are inner surface
marking on an inner surface of the shell.
17. The method of claim 15, wherein the markings are outer surface
markings on the outer surface of the shell.
18. The method of claim 15, wherein the markings are each a post
extending from the shell.
19. The method of claim 15, wherein the markings are each a post
extending toward in inner hollow volume of the shell.
20. The method of claim 15, wherein the markings are arranged so
that a first pair of markings are on opposite sides of the shell on
an x axis of the shell extending along an arch of a jaw containing
the bone socket, a second pair of markings are on opposite sides of
the shell on a y axis of the shell extending lingually and
buccally, and at least part of each marking extending on a z axis
that is substantially parallel to at least one of a soft tissue and
a bone socket axis.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This is a continuation-in-part of application Ser. No.
13/655,056 filed Oct. 18, 2012, which was a continuation-in-part of
application Ser. No. 13/356,359 filed Jan. 23, 2012 and now U.S.
Pat. No. 8,425,231, and which are all incorporated herein by
reference.
FIELD AND BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to the field of
dental implants and, in particular, to a new and useful soft-tissue
preservation temporary in the form of a shell, with an
immediate-implant abutment and a biologically active surface design
that will promote soft-tissue attachment and adhesion according to
the biologic and functional anatomic arrangement to the surface of
the hollow-shell temporary abutment.
[0003] General Considerations and Problems to Overcome:
[0004] The tooth is a structure of the oral cavity which is vital
to the capability of chewing and important to the general
well-being and appearance of people. Anatomically, the tooth
resides within the oral cavity, firmly anchored within the upper
and lower jaws (maxilla and mandible). Human teeth reside within
two distinct anatomic regions of the jaws; the apical inferior
portion of the tooth (the root) is connected to the jaw via an
attachment called the periodontal ligament. We will here define
this portion of the tooth that is connected to the bone as the
"bone-zone" or hard tissue zone of the tooth. Second, the superior
portion of the tooth (the anatomic crown) is connected to the jaw
in the soft-tissue or gingival region of the jaw defined as the
"tissue-zone" or soft tissue zone. The anatomic crown is demarcated
as that portion of the tooth superior to crest of bone and it will
include a small portion of the root superior to the crest of bone
as well as the clinical crown that is visible. The tissue-zone
forms a soft-tissue collar around the neck of a tooth.
[0005] This tissue-zone connection (i.e. soft-tissue to tooth
attachment) is composed of three basic anatomic structures of the
dento-gingival fiber complex. They are defined as:
[0006] (1) the gingival sulcus that is lined by sulcular
epithelium;
[0007] (2) the junctional epithelium; and
[0008] (3) the dento-gingival fibers (a.k.a., the gingival
connective tissues).
[0009] The gingival sulcus is lined by the sulcular epithelum, a
thin non-keratinized stratified squamous cell epithelium without
rete pegs. The length of the sucular epithelium is 1 mm to 3 mm in
height (on average 2 mm), and approximate the smooth surface of the
enamel. The sulcular epithelium extends from the junctional
epithelium to the crest of the soft-tissue free gingival margin.
The sulcular epithelium is extremely important since it acts as the
first line of defense from invasion of micro-organisms into the
oral cavity. Maintenance and preservation of this structure is
important. The sulcular epithelium acts as a semi-permeable
membrane that keeps infecting bacteria by-products from migrating
into the underlying connective tissue.
[0010] The junctional epithelium consists of a collar-like band of
stratified squamous non-keratinized epithelium. It is three to four
layers thick in early life but increases to 10 to 20 layers in
later decades of life. The junctional epithelium is composed of two
grouped states; the basal layer facing the connective tissue and
the supra-basal layer extending to the surface of the tooth,
creating an attachment/adherence to the enamel surface. The length
of the junctional epithelium ranges from 0.25 mm to 1.35 mm (on
average 1 mm) and a thickness of 10 to 29 cells wide to one or two
cells in its apical termination, located at the cemento-enamel
junction. The junctional epithelium is attached to the tooth
surface (epithelial attachment) by means of an internal basal
lamina to the unexposed enamel surface. It is attached to the
gingival connective tissue by an external basal lamina that has the
same structure as other epithelial-connective tissue attachments
found elsewhere in the body.
[0011] The internal basal lamina of the junctional epithelium
consists of lamina densa (adjacent to the enamel) and a lamina
lucida to which hemidesmosomes are attached. Hemidesmosomes have a
decisive role in the firm attachment of the cells to the internal
basal lamina on the tooth surface. Hemidesmosomes may also act as
specific sites of signal transduction and thus may participate in
regulation of gene expression, cell proliferation, and cell
differentiation. Hemidesmosomes attachment has been shown to occur
on a textured surface. The attachment of the junctional epithelium
to the tooth extends apical to the dento-gingival fibers, which
produce a true functional attachment of collagen fibers to the
surface of the tooth to the gingival connective tissue. All the
structures thus far described (Sulcular Epithelium, Junctional
Epithelium and the Dento-Gingival Fibers) are coronal or above
(supra-crestal) to the bone.
[0012] The Dento-Gingival connective tissue is composed of
dento-gingival fibers and connective tissue. The dento-gingival are
composed of collagen fibers that surround the tooth on the facial,
lingual and interproximal surfaces. The length of the supra-crestal
dento-gingival fiber zone ranges from 1 mm to 3 mm and is on
average 2 mm. The fibers are embedded in the surface of the root of
the tooth that is coronal to the crest of bone. The supra-crestal
dento-gingival fiber zone extends from the inferior aspect of the
junctional epithelium to the superior aspect of the bone crest. The
supra-crestal fibers that attach into the surface results from a
cellular and an extracellular compartment composed of fibers and
ground substance. The ground substance fills the space between the
fibers and cells, is amorphous and has a high content of water. It
is composed of proteoglycans, mainly hyaluronic acid and
chondroitin sulfate, and glycoproteins, mainly fibronectin. The
fibronectin binds fibroblasts to the fibers and to other components
of the intercellular matrix, enabling cell adhesion and migration.
Laminin, another glycoprotein found the connective tissue zone
matrix serves to attach it to the surrounding cells. Three types of
connective tissue fibers are found, collagen, reticular and elastic
and are arranged with specific orientations to the surface of the
tooth. The soft-tissue zone stability is established by the
attachment of the fibers to the surface, this is a key factor to
limiting the apical migration of the junctional epithelium. If the
junctional epithelium was to migrate apically it would alter the
functional attachment with negative outcomes as is seen during
periodontal diseases. Therefore, re-establishing the dento-gingival
zone of attachment is critical to the long-term stability and
health of the dento-gingival complex (and soft-tissue zone).
[0013] With reference to FIG. 11, the three zones are described as
Sulcular Epithelium 202, Junctional Epithelium 204, and the
Dento-Gingival Fibers 206 and are noted about the parts of a
natural tooth 102 with its root 104 in a bone socket 106 of a
patient's jaw bone 112. The three zones 202, 204 and 206 are in a
soft tissue socket 108 that will be left after tooth 102 is
extracted. The soft tissue zones follow a peak and valley shape
that mimics the scalloped contour of the free-gingival margin in
gum or gingival 110 found around teeth. The peak and valley contour
of the free-gingival margin is consistent with a peak and valley
contour of the underlying bone around teeth when viewed from the
buccal or lingual aspect. It is commonly understood that peak are
higher (more coronal) between teeth and on the direct surface of
the tooth the valley is (more apical). The differential between
peak and valley is typically 3 mm to 6 mm depending upon the tooth
under discussion. Anterior teeth display a greater peak to valley
contour and posterior teeth display less of this peak to valley
height. The peak to valley contour is commonly understood in
dentistry as the "scallop" of the free gingival margin. Once again,
the soft-tissue contour is reflective of the underlying bony shape
and contour. The hollow shell herein described is designed with the
naturally occurring peak to valley contour. Each zone described
above follow the peak to valley contour on the natural tooth and
therefore a hollow shell which is designed to preserve the anatomic
configuration of the soft-tissue zone should provide a means to
support and allow reattachment to each of these three soft-tissue
zones described. The hollow shell herein disclosed provides a
specific structure for each soft-tissue zone to enable
reattachment/adhesion for that zone. Additionally and importantly
each zone noted on the hollow shell is designed with a peak and
valley configuration so that each given soft-tissue zone is matched
to that zone found nature.
[0014] The soft tissue zone (or tissue zone) connection plays a
critical role in maintaining health of the oral cavity. It does
this by preventing the ingress of microbes and foreign substances
into the body by providing a "biologic-seal" at the interface of
the tooth-jaw connection at the tissue-zone through the
adhesion/attachment of the sulcular epithelium, junctional
epithelium and gingival fibers. This functional attachment of the
soft-tissue to the surface of the tooth should be fully appreciated
as a critical defense barrier. As without the presence of this
soft-tissue biologic seal the underlying bone would be vulnerable
to numerous invasions of various foreign substances.
[0015] In addition, the tissue-zone plays an essential role in
maintaining and preserving the dental esthetics of the smile. This
same tissue-zone represents the peaks (papillae) and valleys of the
soft-tissue gingival that surround the neck of each and every
tooth. These peaks and valleys have been defined for the
hollow-shell temporary implant abutment herein referenced as our
previous U.S. Pat. No. 8,425,231.
[0016] It is the spatial relationship of tooth form and color with
healthy soft-tissue gingival architecture that are known as the
essential building blocks of dental esthetics as we know it.
Experts of dental esthetics have called the soft-tissue gingiva
"the frame" of the picture, and regard the teeth as the "subject
matter" of that painting. Disregarding the frame of a painting
would certainly impact the overall esthetic appearance being
viewed, and the same is true with respect to the gums and teeth.
The loss or the alternation of anatomic structures of the
tissue-zone has been shown to lead to an inferior esthetic outcome
in addition to causing a potential risk of disease for the
patient.
[0017] The tooth and its attachment to the jaw is subject to
numerous pathogens over the lifetime of a patient, particularly due
to trauma/fracture, endodontic failure, decay, localized
periodontal disease, etc. Any of these conditions can lead to the
eventual need for removal of either a single tooth or multiple
teeth. The removal or extraction of a tooth or teeth will result in
a radical morphologic change to the anatomy as well as the
potential exposure of the internal tissues (connective tissues and
underlying organs) of the body to invasion by foreign
substances.
[0018] The extraction of a tooth results in a cascade of changes
depending on how this procedure is performed. Tooth removal in the
past has been a highly traumatic surgical procedure. It was not
uncommon for an oral surgeon to fully reflect the gingival tissues
as a surgical flap to expose the underlying tooth and bone to aid
in the ease of access and visualization of the tooth to be removed.
It is during this surgical reflection of the gingival soft-tissues
that the normal anatomy of the tissue-zone would be radically
altered and permanently changed. Destruction of the normal
architecture of the gingiva occurs as surgical instruments were
used to cut, tear, crush and rip the attachment fibers between the
tooth and soft-tissues of the tissue-zone. In accordance with
gingival surgical flap surgery, closure of a surgical flap is
accomplished with the placement of sutures to close the wound
created. Primary (or complete) flap closure is highly desirable to
ensure the re-establishment of a biologic-seal of the soft-tissue
to prevent ingress of foreign bodies to the host.
[0019] Gingival flap surgery also has the known deficiency to
result in bone loss from the stripping away of the periosteum and
hence the blood supply to the bone during the reflection of a
surgical flap. It is well documented in the dental literature that
gingival surgical flaps result in bone loss by the exposure of the
underlying bone. Dr. Lindhe and co-workers have scientifically
demonstrated that surgical flap elevation and removal of teeth
leads to loss of the residual bone and the shape of remaining ridge
after tooth removal. These undesirable anatomic changes to the bone
make the placement of implants more complex and increases risk for
patients.
[0020] For the reasons identified above, the trend toward minimally
invasive surgical procedures has been developed toward the
extraction of teeth. Examples of these changes include the use of
micro-surgical instruments, periotomes and extraction forceps that
do not require the reflection of a surgical flap to remove teeth.
Ultrasonic (piezo technology) surgical instruments, dental lasers
and rotary devices have been suggested as mechanisms to minimize
trauma during the removal of teeth. It is generally accepted within
the profession that a minimally invasive technique for tooth
removal should be the standard of care.
[0021] In an attempt to minimize detrimental anatomic changes
during the surgical removal of a tooth, a major effort is now
underway to preserve the bone-zone and tissue-zone after tooth
removal. The objective of the dental profession to preserve bone
was a natural extension of a vast body of knowledge recently
created on periodontal bone regeneration via the use of bone
replacement substances. Examples of such efforts include
autografts, allografts, xenografts and a variety of bone
replacement materials that include; Bone Morphogenic Proteins
(BMP's), Stem Cell Derivatives, Platelet Rich Proteins (PRP's)
derived from the blood and numerous other biologic sources. Bone
regeneration after periodontal disease is well established in the
prior art. A deficiency of using bone replacement substances, are
the inability to contain and protect these materials to exposure to
the oral cavity during the critical healing phase, i.e. a
fundamental inability to re-establish the all-important
biologic-seal of the Tissue-Zone once a tooth is removed.
[0022] The use of barrier membranes for guided tissue bone
regeneration (GTR) is known attempts to preserve and regenerate
lost bone after periodontal disease. The use of membranes has more
recently been applied to the regeneration and preservation of bone
after tooth removal. Barrier membranes assist in creating a
protective barricade to the bone-zone by excluding unwanted cells
(connective tissue cells) to the healing site. This is an attempt
to allow the body to more effectively refill a residual bony socket
with bone cells (a.k.a. osteoblasts) known to be critical for bone
growth. A general deficiency of using barrier membranes is the
direct exposure of a barrier membrane that consequently lends to
the inability to establish a soft-tissue seal. The exposure of the
barrier membrane leads to plaque accumulation on the surface of the
membrane that is impossible to clean. Once membranes become exposed
to the oral environment, bacteria colonization on the surface of
the membrane quickly spearheads an infection and/or failure of
regeneration of bone. The primary cause of the exposure of the
membrane is a lack of a soft-tissue biologic-seal after gingival
flap surgery. The inability to re-establish a biologic-seal after
the removal of a tooth has many repercussions to bone and soft
tissue regeneration.
[0023] Loss of the biologic-seal of the tissue-zone also has a
significant impact on soft-tissue changes to both the macro- and
micro-anatomy of the gingiva. It is accepted in the dental
literature that the loss of gingival attachment within the
tissue-zone leads to the irreversible loss of the interdental
papillae and the gingival architecture surrounding a tooth. There
are currently no predictable surgical techniques available to
correct the gingival changes to vertical height and horizontal
dimensional after tooth removal. Much effort has been directed
toward preserving the bone after tooth removal but far less effort
has been applied to preserving the macro- and micro-anatomy of the
tissue-zone after tooth removal.
[0024] As previously noted, the dento-gingival fiber complex plays
a vital role in the protection of the host from foreign
micro-organisms. The re-establishment of a biologic-seal that
reconstitutes the macro- and micro-anatomy of the dentogingival
complex is therefore essential to the long term maintenance of
optimal health of the oral cavity and consequently the individual.
Mechanical attachment of the underlying tissues to a tooth or
abutment-implant tooth replacement within the tissue zone is
facilitated by the cells of the dentogingival complex (sucular
epithelium, junctional epithelium and gingival fibers).
[0025] A combination of focal points of adhesion contact,
hemidesmosmal adherence/attachment and finite collagen fiber
bundles, play a key role in the attachment interface. Histochemical
evidence for the presence of neutral polysaccharides and the
production of luminin provide an important contribution to the
attachment interface at the level of the junctional epithelium. The
gingival fiber attachment is composed of collagen fibers,
fibroblasts, vessels, nerves and extracellular matrix. The bi-layer
of the connective tissue; of the papillary layer subjacent to the
epithelium and the reticular layer contiguous with the periosteum
also contribute to a functional interface and hence the biologic
seal found in the tissue zone. Maintenance of the attachment and/or
adhesion of the soft tissue cells to the tooth surface are
regulated via inter-cellular signaling (transduction) of the
undifferentiated and differentiated cells, such as fibroblasts,
cementoblasts, endothelial cells, as well as, the hemidesmosmal
cells of the soft tissues.
[0026] As will be explained more fully in the following, the new
method and arrangement of the present invention is an effective
means to preserve anatomic architecture of the tissue-zone after
tooth removal and a means to re-establish the adherence and
attachment of the adjacent soft tissue via a biologic seal at the
time of an immediate placement of a dental implant. In addition,
the present invention describes a means of providing a biologic
surface onto an abutment to which the biologic seal is promoted and
can be re-established.
[0027] The understanding of using a minimally invasive technique as
well as re-establishing a biologic-seal after tooth removal has
been discussed but has not yet been made possible in all cases by
known methods and apparatuses. In addition to these important
concepts one further concept related to tooth removal is the
technique of immediate dental implant placement after the
extraction of a tooth/teeth and the ability to provide a surface
texture, surface or biologically active layer upon the surface to
promote re-establishment or new attachment/adhesion to the surface
of the implant abutment.
[0028] The replacement of a tooth by a dental implant device is
well known in the prior art. It is understood that there are two
basic components to the dental implant device; the root-form
component held within the bone-zone commonly referred to as the
"dental implant" and a second component, the implant anatomic crown
composed of an abutment and clinical crown. Both the abutment and
clinical crown are typically placed superior to the crest of bone
therefore within and superior to the tissue-zone. An implant
prosthesis was first described as a surgical method and device that
used a fully submerged, non-loaded healing period prior to the
connection of the dental implant crown.
[0029] The advent of contemporary implant dentistry was first
described by Prof. P. I. Branemark in the late 1970's and
established the use of a titanium root-form screw to be inserted
into the bone placed by using an atraumatic surgical technique
described by this researcher/inventor. The method described by
Branemark discussed the placement of the dental implant into
jawbone of a fully edentulous ridge. He described a method in which
the implant would be fully submerged and non-loaded during a
healing period of 4-6 months after the dental implant was placed
and covered within the bone. Pre-operative conditions therefore
required a fully healed ridge in which teeth were previously
removed. The method of using a submerged, non-loaded healing period
for dental implants remains an approach still widely utilized
today.
[0030] However, over the past 30 years alternative methods to
implant placement have occurred. The following are different
methods that have been advocated to the non-submerged, non-loaded
implant healing technique.
[0031] Advantages and disadvantages will be briefly discussed for
each technique.
[0032] Delayed, Submerged, Non-Loaded Implant Placement Method:
[0033] Defined as the method for placing a root-form dental implant
into the jawbone. The implant is placed within the bone-zone
initially. The pre-operative condition requires an edentulous
ridge. The technique describes the placement of the implant into
the bone at or below the crest of bone and it is fully covered by
primary flap closure. An initial healing for a period of 4 to 6
months is required. A second surgery is required to expose the
root-form implant and to connect a healing abutment. Second healing
period of 2-3 months is required for soft-tissue. Final crown
delivery occurs approximately 9 months after the start of
treatment.
[0034] Deficiencies of this Method:
[0035] 1. Requires multiple surgeries prior to implant crown
placement.
[0036] 2. Requires an edentulous ridge prior to implant placement
into the bone-zone resulting in the irreversible changes to the
soft-tissues of the tissue-zone.
[0037] 3. Difficult to re-establish a biologic-seal after numerous
surgeries and the connection of the implant crown.
[0038] 4. Increased cost because of multiple surgeries and
prosthetic components.
[0039] 5. Previous implant system provided a bone-zone solution to
osseo-integration of a root form implant within the bone. These
systems were not designed with a separate component that is devised
to re-establish the soft-tissue zone connection in the immediate
implant placement.
[0040] 6. Does not provide a suitable surface adjacent to the host
soft-tissue zone (dentogingival complex) to promote or re-establish
a biologic seal during the extraction and immediate implant
placement.
[0041] Delayed, Non-Submerged, Non-Loaded Implant Placement
Method:
[0042] Defined as the method for placing a root-form dental implant
into the jawbone exemplified by the Straumann, ITI implant company.
The implant is placed within the bone-zone initially. The
pre-operative condition requires an edentulous ridge. The technique
describes the placement of the implant into the bone at or below
the crest of bone or within the tissue-zone. A transmucosal healing
cap component is used. A healing abutment or "cap" is placed onto
the implant that is in direct contact with the soft-tissue during
the initial bone-healing period of 4 to 6 months. A second surgery
is not required to expose the root-form implant. Reformation of the
tissue-zone is required. A connection between the implant and the
healing abutment is within the tissue-zone.
[0043] Deficiencies of this Method:
[0044] 1. Requires an edentulous ridge prior to implant placement
into the bone resulting in the irreversible changes to the
soft-tissues of the Tissue-Zone.
[0045] 2. Requires flap surgery to place dental implant.
[0046] 3. Difficult to re-establish a biologic-seal after surgery
and the connection of the implant crown.
[0047] 4. Difficult to re-establish soft-tissue anatomy to the
state it was prior to tooth removal.
[0048] 5. Healing abutment has a connection interface within the
Tissue-Zone, which allows bacteria to adhere impeding wound
healing.
[0049] 6. Increased cost because of multiple components.
[0050] 7. Does not provide a means to maintain the original soft
tissue architecture while affording a suitable surface for
re-attachment at the time of tooth removal and immediate implant
placement.
[0051] Immediate Root-Form Implant Placement:
[0052] A recent trend in implant dentistry that has occurred, that
overcomes the deficiency of requiring multiple surgeries, is the
immediate placement of a root-form dental implant directly into an
extraction socket after tooth removal.
[0053] This method deviates from the original protocols established
by Branemark and co-workers. The advantage to the simultaneous
placement of a root-form dental implant after tooth removal is the
reduction of the number of clinical procedures required as well as
decreased treatment time. This technique eliminates the need to
have the bone ridge healed after tooth removal consequently
requiring fewer surgical procedures.
[0054] Immediate implant placement requires a mechanical locking of
the root-form dental implant into the residual socket-site after a
tooth has been removed. Mechanical locking refers to the root-form
implant engaging undisturbed bone in an attempt to provide primary
mechanical stability of the implant within the extraction socket.
Immediate implant placement is highly desirable in comparison to
delayed implant placement since it allows the immediate replacement
of the tooth at a substantially reduced amount of time when
compared to previous method of delayed implant healing.
[0055] Immediate Implant Placement Presents Numerous Risks and
Deficiencies with Current Methods Used:
[0056] 1. An inability to fully engage the entire remaining socket
surface after tooth removal, thereby leaving a space (gap) between
the surface of the implant and the surface of the remaining
bone.
[0057] 2. An inability to establish a biologic-seal to the
overlying soft-tissues after a tooth has been removed.
[0058] 3. An inability to retain bone regenerative materials if a
residual gap remains between the surface of the implant and the
bone socket.
[0059] 4. An inability to establish a biologic-seal of the
soft-tissue over a barrier membrane to protect and contain bone
regeneration materials and the blood clot.
[0060] 5. Inability to preserve the soft-tissue architecture of the
gingival of the Tissue-Zone.
[0061] 6. Inability to promote and/or re-establish a cellular and
soft-tissue attachment and/or adherence of the adjacent soft-tissue
zone defined as the dentogingival complex to the surface of the an
immediate implant abutment.
[0062] The deficiencies of achieving a predictable and esthetic
long term outcome when using an immediate implant placement
protocol can all be directly attributed to the inability to
establish an acceptable soft-tissue adaptation that creates an
effective biologic-seal, one which re-establishes a true
histological and biochemical attachment in the tissue-zone of the
remaining soft-tissue socket after removal of a tooth.
[0063] Immediate implant placement of a root-form dental implant
has been shown to effectively osseointegrate by numerous authors
(reference included herein). The residual gap that is present
between the implant surface and the bone surface requires careful
management whether a surgical flap is performed or a non-flapless
minimally invasive extraction technique is used. In either of these
two approaches, irreversible soft-tissue changes have been shown to
occur with immediate implant placement after tooth removal. Changes
within the tissue-zone are shown to occur as early as several hours
to more extensive changes over several days after the immediate
implant placement.
[0064] Numerous authors (reference included herein) have discussed
the use of a biologically active surface and the importance of a
soft tissue attachment of a medical (dental) implants (e.g.,
stents, dental implants, canulas and the like). Areva, et.al.
(2004, J Biomed Mater Res., 70A: 169-178) described the use of a
non-resorbable reactive tetraisopropyl orthotitanate layer (i.e.,
sol-gel derived nano-porous titania coating) dissolved in absolute
ethanol. A second solution of Ethyleneglycol monoethylether
deionized water and fuming hydrochloric acid (HCL, 37%) dissolved
in ethanol. The two solutions are mixed and aged for 24 hours and
used as a dip-coating process on a titanium substrate. The detailed
process described by Areva and co-workers as a "sol-gel derived
titania coating" used to produce a soft tissue attachment. Their
histo-morphological and chemical analysis using scanning electron
microscope equipment demonstrated a good adherence and direct soft
tissue attachment of the treated surface.
[0065] Rossi, et. al., in a subsequent publication (Peri-Implant
tissue response to TiOxide surface modified implants. Clin Oral
Impl Res. 19, 348-355, 2008) described the use of a TiOxide thin
film layer applied to a smooth implant surface promoting a
hemidesmosome attachment. This animal study demonstrated
histological and histomorphometric arrangements of the sucular
epithelium, junctional epithelium and gingival fibers with direct
contact and attachment to the surface of the implant when treated
with a thin film TiOxide applied layer. Within the limitations of
this study it can be concluded that a non-porous TiOxide surface
offers good soft tissue attachment around root form implants.
[0066] In addition to the application of a biologically active
surface noted above, numerous researchers have discussed the
benefits of altering surface properties of an implants with respect
to the micro- and macro-morphology of the surface of implants to
promote attachment to the implant surface. Such examples relate to
laser etching, roughness and texture. Ricci and co-workers (Key
Engineering Materials, Vols 198-199; 179-202.2001) describe the
effects of textured surfaces on colony formation by fibroblasts and
effects of controlled surface micro-geometries. Based on this
research a laser micro-grooved surface was tested. Specific size
ranges were applied producing a controlled micro-geometry to
enhance bone and soft tissue integration. Subsequent studies by
this team lead to the development of a patented laser
micro-grooving surface morphology (U.S. Pat. No. 6,419,491 herein
referenced). Laser micro-grooving surface texture has demonstrated
increased soft tissue adhesion and attachment to the surface of
titanium dental implants. Other surface characteristics such as
hydrophilicity and the use of depositing non-toxic salt residue on
a roughened surface of the implant has been described (U.S. Pat.
No. 8,309,162 to Charlton, et.al.). Charlton and co-workers
described an acid-etched roughened surface with an array of
microscale irregularities having peak-to-valley heights not greater
than 20 microns. A method of applying discrete hydroxyapatite
nano-crystals on the roughened surface exposed to a solution
comprising non-toxic salts to promote cell attachment is disclosed.
In the same patent, a method of increasing the hydrophilicity by
depositing a non-toxic sodium lactate salt residue on the surface
of a dental implant to be implanted into living bone promoting
improved osseo-integration (cellular attachment) is claimed and
described.
[0067] Liu, et.al, U.S. Pat. No. 7,341,756 describe applying a
multi-layer derived alkoxide on a substrate having a dimension
suitable for an implant and forming a second coating layer on the
first coating layer that promotes osseointegration. The patent
further describes the multi-layer surface applies sol-gel
processing to produce a nanometer scale of calcium phosphate (e.g.,
HA) ultrathin-coating. The bioactive surface of the multi-layer
surface coating accelerated osteoblast adhesion and may generate
improved osseo-integration of implants within bone. Results of such
a surface coating indicted that genes associated with bone
formation (co11, OPN, OCN) were unregulated with the multi-layer
surface described.
OTHER PRIOR ART
[0068] U.S. Pat. No. 5,417,568 to Giglio discloses a dental
prosthesis that is said to accommodate the gingival contours
surrounding the implant prosthesis by imitating the gingival
contours around natural teeth. Since the abutment is rigidly
connected to the implant and must always be axially aligned with
the long axis of the implant, the abutment will rarely, if ever,
closely engage the entire existing soft-tissue socket created when
a tooth has been extracted; consequently, inadequate soft tissue
socket adaptation exists. Moreover, seldom is the axis of the
implant exactly aligned with the axis of the soft-tissue socket.
Also, although the abutment disclosed by this patent has raised
ridges around its outer perimeter, it is symmetrical, and therefore
does not mimic the asymmetric anatomy of a soft-tissue socket in
the gingiva of a patient from whom a tooth has been extracted.
[0069] Nowhere in the prior art or in current dental implant wisdom
is an anatomically shaped and sized abutment in the form of a
hollow, asymmetric tubular shell used in conjunction with a dental
implant, which is not rigidly or concentrically connected to the
implant in advance. As a result of the invention here disclosed,
the shell can be moved and maneuvered to any orientation in the x-,
y- or z-axis in a soft-tissue socket to effectively and fully
engage the tissue-zone with no space or gap between the outer
surface of the shell and the soft-tissue socket, independent of the
position and axial orientation of the implant in the bony socket.
The mechanical de-coupling of the abutment shell from the implant
is one of several important advancements of this invention over the
prior art.
[0070] U.S. RE37,227 to Brodbeck also disclosed a some-what
anatomically shaped abutment but again it is axially fixed to an
implant so that there is no freedom of movement between the
abutment and the implant but rather they are mechanically coupled
to each other when being seated in their respective soft-tissue and
bone sockets.
[0071] An article titled: "Immediate Placement and
Provisionalization of Maxillary Anterior Single Implants: A
Surgical and Prosthodontic Rationale," by Kan at al., Pract
Periodont Aesthet Dent, 2000; Vol. 12, No. 9, pps 817-824,
discloses the building up of an abutment that is fixed to an
implant to better match a soft-tissue socket by the addition of
autopolymerizing acrylic resin around the abutment by sculpting the
outer shape of the otherwise fixed abutment to better fill the
soft-tissue socket. This technique also fails to recognize the
advantage of mechanically decoupling the abutment from the implant.
In addition, the tissue-zone collapses immediately upon tooth
removal and extrapolation of its contours by the author is required
to recreate as close as possible the soft tissue-zone profile.
[0072] Nowhere in the prior art or in current dental implant wisdom
is an anatomically shaped and sized abutment in the form of a
hollow, asymmetric tubular shell in which a biologically active
surface consisting of, but not limited to, surface texture, surface
roughness, hydrophilic surface, surface conditioning by applying
bio-active agents, creating of a macro- and micro-geometric pattern
and/or micro- and macro-morphology surface irregularities (as those
previously referenced and described above) to promote the
soft-tissue attachment and/or adhesion of the dentogingival complex
within the tissue-zone of an immediately placed implant abutment
which is capable of making contact with the entire soft-tissue
socket when placed upon the immediate implant of the extracted
tooth site.
[0073] Nowhere in the prior art is a discussion or apparatus that
allows a biologically active surface as described above to have
intimate contact with the exposed soft-tissue socket immediately
after tooth removal and is capable of compensating for eccentric
positioning of the dental implant secured within the bone. The
apparatus thus provides a means to allow immediate cellular
activity from physical contact of the apparatus surface to the
direct contact of the soft-tissue surface without the presence of a
gap. Additionally, the biologic mediators described above are thus
capable of promoting a direct soft-tissue attachment and/or
adherence of the implant abutment to the immediate soft-tissue
residual socket of the extraction tooth.
[0074] Another attempt at accommodating the miss-match between an
implant oriented in a bony socket and an abutment positioned in a
soft-tissue socket, is suggested in the June 2009 brochure of
BIOMET 3i titled "Ideal Solutions For Immediate Aesthetics" that
discloses an abutment-implant combination where the abutment axis
is at a fixed but non-aligned angle to the implant axis. Here again
there is no decoupling of the abutment from the implant so freedom
of orientation is not present. Nor is there the suggestion of a
biologically active surface that can promote re-attachment of the
soft-tissue to the surface of the abutment-implant.
SUMMARY OF THE INVENTION
[0075] The present invention seeks to establish a biologic active
surface that is achieved by coating, applying or conditioning the
surface of our temporary shell of the invention. We disclose a
surface that may be coated by an organic or inorganic surface layer
to promote and/or achieve a biological and anatomic connection of
the cells of the soft-tissues to the surface of the shell. Thus,
promoting and establishing the optimal soft tissue gingival
seal.
[0076] A major advantage of the invention is that the structure of
the hollow shell makes intimate contact with the entire surface of
the soft-tissue socket at the time the extraction is performed. The
hollow shell comes into direct contact along the entire surface of
the shell with a biologically active agent to promote soft-tissue
re-attachment and/or adherence.
[0077] Providing a biologic or biologically active agent at the
time of tooth removal is different then at any other time. Wound
healing cells and mechanisms are temporal and having them present
with a direct contact to the biological active agent on the surface
of the hollow shell is a unique circumstance of this invention.
[0078] It is an object of the present invention to solve the
problems of the prior art by providing a soft-tissue preservation,
dental implant arrangement, that comprises: a hollow shell with an
interior volume and a shell axis, the hollow shell having an outer
bio-compatible surface for engaging a soft-tissue socket that is
left in gingival tissue after a tooth has been extracted from a
bone socket under the gingival tissue, the shell having a first
perimeter adapted for placement toward the bone socket and a second
perimeter adapted for placement adjacent an outer surface of the
gingival tissue around the soft-tissue socket, the first perimeter
being smaller than the second perimeter so that the shell tapers
outwardly from the first to the second perimeters, the second
perimeter being asymmetrically scalloped with opposite distal and
mesial peaks and opposite lingual and facial valleys between the
peaks, and the shell being sized for closely engaging against the
soft-tissue socket without gaps; a dental implant having an implant
axis and being adapted for placement in the bone socket; a
temporary post rigidly connected to and coaxial with the dental
implant, the temporary post extending in the interior volume of the
hollow shell; and a luting compound filling the interior volume
between the shell and the temporary post and setting solid for
fixing the shell to the dental implant with no other connection
between the shell and the implant so that the outer surface of the
shell engages against the soft-tissue socket without gaps and
without requiring alignment of the shell axis to the implant
axes.
[0079] The above described hollow shell to be composed of a
bio-active outer surface that is defined by but not limited to, a
particular surface texture, surface roughness, hydropholic surface,
surface conditioning by applying bio-active agents, creation of a
macro- and micro-geometric pattern and/or micro- and
macro-morphological surface irregularities (as those previously
referenced and described above) to promote soft tissue attachment
and/or adhesion of the dentogingival complex. The biologically
active surface of the hollow shell is to make direct and intimate
contact about the entire surface with the "fresh" soft-tissue
socket and peri-implant tissues of the extracted tooth. The hollow
shell with bioactive surface interacts with the exposed
soft-tissues at the time of the removal of the tooth. This
condition is unique in time and space. It is known that wound
healing is a cascade of cellular responses that occur and only
occur at specific times that are in relation to the traumatic event
within time. The removal of a tooth starts this cascade of wound
healing events by exposing the "fresh" surface of the soft-tissue
after tooth removal. There is a distinct advantage for wound
healing that is enabled at a specific time thus allowing the
biologically active surface to be in intimate and immediate contact
to the soft-tissue at the time of tooth removal. This condition is
one that is temporal and is unique to the method herein described
in which a biologically active surface can comes into intimate and
direct contact with the "fresh" soft-tissue socket to promote the
re-attachment and/or direct chemical adherence of this surface to
the newly exposed soft-tissue.
[0080] The preferred embodiment of this method and apparatus are
specific to the immediate extraction site and placement of the
immediate implant and overlying immediate implant abutment. The
inventor's clinical experience and case studies have shown that
allowing a biologically active surface of the hollow shell to be in
contact with the immediate and "fresh" soft-tissue extraction site
enables a cascade of wound healing that is not present under any
other conditions. This has resulted with the ability to demonstrate
tissue attachment and true adherence typically only found prior to
tooth removal.
[0081] In the preferred embodiment the invention provides a
textured and coated outer surface of the hollow shell composed of
three distinct zones corresponding to those shown FIG. 11. Each
zone is designed with the peak and valley contour arrangement that
parallels the upper (coronal) edge of the hollow shell. This peak
and valley contour is consistent with the three zone that were
previously described relating to the sulcular epithelium,
junctional epithelium and dento-gingival fiber zone, respectively
found juxtaposing a tooth. In the preferred embodiment, the most
upper (coronal) of the three zones is the sulcular epithelium zone
that is designed to be 2 mm in height. The middle zone on the
hollow shell which approximates the junctional epithelium zone is
designed to be 1 mm in height and the third zone, the bottom
(apical) zone which will approximate the dento-gingival fibers of
the connective tissue is designed to be 2 mm in height on the
surface of the hollow shell.
[0082] A lower (apical) zone of the hollow shell is textured with a
pitted-roughened surface with a diameter of 25 to 50 microns and 5
to 10 microns in depth for the surface texture. The height of the
zone is 2 mm and will approximate the dento-gingival connective
tissue and fibers of the residual soft-tissue zone. This band of
the hollow shell corresponds to the surface of the tooth in which
the dentogingival fibers insert on the surface of the tooth. It is
conceivable that this zone of the hollow shell is coated with a
biologically active agent that produces proteoglycans and
cementogenesis to further encourage the dento-gingival fibers to
insert into the surface. It is understood that the surfaces of the
hollow shell are not limited to three distinct zones and could be
one or more zones of any of the surface textures described. It is
understood that each zone (band) of the hollow shell will follow
the contour of the upper (coronal) edge of the hollow shell
structure with a peak and valley shape reflective of the
soft-tissue zone.
[0083] A further and more general object of the invention is to
provide a dental implant method and arrangement that uses a hollow
shell with outer bio-compatible surface for engaging a soft-tissue
socket that is left in gingival tissue after a tooth has been
extracted to promote healing by mechanically decoupling the shell
from an implant that has been fixed in the remaining bony socket,
the shell being tapered outwardly from a first to a second
perimeter, the second perimeter being asymmetrically scalloped with
opposite distal and mesial peaks and opposite lingual and facial
valleys between the peaks, the dental implant in the bone or bony
socket left after tooth extraction being rigidly connected to a
temporary post, the temporary post extending in the shell and a
luting compound filling the volume between the shell and the post
and setting solid for fixing the shell to the dental implant with
no other connection between the shell and the implant so that the
outer surface of the shell engages against the soft-tissue socket
without gaps and without requiring alignment of the shell and
implant axes.
[0084] Another object of the invention are to use the shell as a
biological seal enhanced and promoted through the use of a
biologically active surface for both the soft-tissue socket and for
the bony socket, to preclude contaminants from the soft-tissue and
from the bony sockets. The biologically active agents may also
retard the growth of opportunistic pathogens at the interface.
Namely, the addition of a biologically active surface may also
prevent the colonization of bacteria and the like as well as reduce
the inflammatory reaction typically associated with host
challenges. We anticipate that a biologically active surface is
also a surface that is defined to prevent specific cellular
proliferation and adverse outcomes. It is conceived that the use of
a biologically active surface includes a particular surface
texture, surface roughness, hydrophilic surface, surface
conditioning, macro- and micro-geometric pattern and/or micro- and
macro-morphological surface irregularities (as those previously
referenced and described above) to promote and prevent specific
cell populations from soft tissue attachment and/or adherence. An
example of this concept would be a biologically active surface that
will prevent the apical (downward) migration of sucular epithelium
onto the entire surface of the hollow shell. A further example
would be a biologically active surface that will prevent an apical
migration of the Junctional Epithelium onto the surface of an
immediate implant abutment that would otherwise be an area with
dentogingival fiber attachment. In conclusion, the hollow shell
with a biologically active surface is capable of controlling
selective cellular repopulation along its surface thereby promoting
a true re-attachment and/or adherence of the immediate soft-tissue
extraction site.
[0085] The present invention also includes another important
concept that the biologically active surface can also prevent
undesirable cellular attachment and/or adhesion in addition to the
general concept of preserving and promoting re-attachment.
[0086] Another object of the invention is to use the shell as a
foundation for a temporary prosthetic tooth for immediately
cosmetically replacing an extracted tooth.
[0087] Other objects of the invention will become apparent after
considering the following more detailed disclosure of the
invention.
[0088] The various features of novelty which characterize the
invention are pointed out with particularity in the claims annexed
to and forming a part of this disclosure. For a better
understanding of the invention, its operating advantages and
specific objects attained by its uses, reference is made to the
accompanying drawings and descriptive matter in which preferred
embodiments of the invention are illustrated.
BRIEF DESCRIPTION OF THE DRAWINGS
[0089] In the drawings:
[0090] FIG. 1 is an exploded view of important part of the
arrangement of the invention;
[0091] FIG. 2 is a perspective view of a different embodiment of
the shell of the invention for use in replacing a different tooth
type and illustrating the outer zones of different surface type of
the invention;
[0092] FIG. 3 is a perspective view of a still further embodiment
of the shell of the invention for use in replacing a different
tooth type and illustrating the interior markings for use as
drilling guides according to the invention;
[0093] FIG. 4 is a perspective view of an embodiment of the shell
of the invention that illustrated the asymmetry of the outer
perimeter of the shell and also illustrating orientation
directional guide posts to also aide in drilling according to the
invention;
[0094] FIG. 5 is a perspective view of the shell of the invention
shown also in FIG. 1 for comparison and illustrating external
drilling guide marking of the invention;
[0095] FIG. 6 is a view of a shell like that of FIG. 2, but with
orientation directional drilling guide posts extending apically of
the shell;
[0096] FIG. 7 is a perspective view of another embodiment of the
shell with outer markings;
[0097] FIG. 8 is different perspective view of a shell like that of
FIG. 7 but with inner markings;
[0098] FIG. 9 is top view of the shell of FIGS. 7 and 8, with
labial markings;
[0099] FIG. 10 is bottom view of the shell of FIGS. 7 and 8, with
labial markings;
[0100] FIG. 11 is side sectional view of a natural tooth in a human
jaw to illustrate key areas of the anatomy of the tooth and its
surroundings for a better understanding of the invention;
[0101] FIG. 12 is side sectional view of a shell of the invention
in soft tissue socket after a tooth has been extracted to
illustrate the invention;
[0102] FIG. 13 is a composite view of an extraction site with one
type of shell of the invention for use as a drilling guide for an
implant hole at the site; and
[0103] FIG. 14 is a view similar to FIG. 13 of another type of
shell of the invention for use as a drilling guide for an implant
hole at the extraction site.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0104] Referring now to the drawings, in which like reference
numerals are used to refer to the same or similar elements, FIG. 1
illustrates a soft tissue preservation, dental implant arrangement,
that comprises a hollow shell 10 with an interior volume and a
shell axis 12. The shell is advantageously made of zirconium
dioxide (ZrO.sub.2) ceramic material that is known to be
bio-compatible. The hollow shell 10 thus has an outer
bio-compatible surface for engaging a soft-tissue socket that is
left in gingival tissue after a tooth has been extracted from a
bone or bony socket under the gingival tissue. Shell 10 has a first
lower perimeter 16 adapted for placement toward the bone socket of
a lower mandibular, tooth. The first or inner perimeter 16 may be
an upper perimeter if the shell is to be used for replacing of an
extracted upper or maxillary tooth so that terms like "upper" and
"lower" as used here are only relative terms and do not convey an
absolute position or limitation of the invention.
[0105] Shell 10 also has a second or outer perimeter 18 adapted for
placement adjacent an outer surface of the gingival tissue, around
the soft-tissue socket. The first perimeter 16 is smaller than the
second perimeter 18 so that the shell 10 tapers outwardly from the
first to the second perimeters to anatomically mimic the shape of
the soft-tissue socket that remains immediately after a tooth has
been extracted, and before the soft-tissue socket starts to shrink
or shift from the natural size, shape and position it had around
the patient's natural tooth before extraction.
[0106] To further anatomically mimic the shape of the soft-tissue
socket, the second perimeter 18 is also asymmetrically scalloped
with opposite distal and mesial peaks 20 and 22, and opposite
lingual and facial valleys 24 and 26, between the peaks. The
shapes, sizes, locations and heights of the peaks and valleys are
selected to mimic known tooth types, e.g. maxillary or mandibular,
central or lateral incisors, canines, premolars and molars, and the
shell is also sized for closely engaging against the soft-tissue
socket without gaps of many tooth shapes, types and sizes. This
sizing and shaping is achieved by providing the practitioner with a
set or selection of different shell shapes, sizes and types, so
that a shell 10 that is close in fit to the soft-tissue socket is
available, so that the shell engages the soft-tissue socket without
gaps and thus forms a biological or biologic-seal to preclude
contaminants from the soft-tissue socket and from the bony socket
in the bone under the soft tissue.
[0107] According to the invention as shown in FIG. 2, the outer
surface if shell 10 is divided into at least two and preferably the
zones 302, 304 and 306 corresponding to the gingival sulcus (202),
junctional epithelium (204) and dento-gingival fiber (206) zones of
the natural soft tissue socket shown in FIG. 12 at 108 in the
gingiva 110.
[0108] One or more biologically active agents, such as but not
limited to, a particular surface texture like macro-grooves are
provided in zone 304, surface roughness, hydrophilic surface,
surface conditioning or applying bio-active agents of a different
type are on the surface of shell 10 in zone 306, and zone 302 is
left smooth. Alternatively creating of a macro- and micro-geometric
pattern and/or micro- and macro-morphological surface
irregularities (as those previously referenced and described above)
are applied to the different zones 302, 304 and 306, to make best
biocompatible contact with the respective zones 202, 204 and 206 of
the soft tissue socket and further enhance preservation of the
anatomy of the socket in preparation for its eventual engagement by
a crown or permanent tooth replacement that will replace the shell
10.
[0109] In conjunction with an immediate implant technique of the
invention, and by using the inventive multi-zone shell 10, the soft
tissue socket experiences the least amount of trauma.
[0110] In greater detail, the preferred embodiment the invention
provides a textured and coated outer surface of the hollow shell 10
composed of three distinct zones, namely a third zone or band 302,
a second zone or 304 and a third zone or band 306 in FIGS. 2 and
12, corresponding to the soft tissue zones 202, 204 and 206 shown
in FIGS. 11 and 12.
[0111] Each zone is designed with the peak and valley contour
arrangement that parallels the upper (coronal) edge of the hollow
shell. This peak and valley contour is consistent with the three
zones that were previously described relating to the sulcular
epithelium, junctional epithelium and dento-gingival fiber zone,
respectively found juxtaposing a tooth. In the preferred
embodiment, the most upper (coronal) of the three zones is the
sulcular epithelium zone that is designed to be 2 mm in height. The
middle zone on the hollow shell which approximates the junctional
epithelium zone is designed to be 1 mm in height and the third
zone, the bottom (apical) zone which will approximate the
dento-gingival fibers of the connective tissue is designed to be 2
mm in height on the surface of the hollow shell. Each zone on the
hollow shell is designed to promote the cell specific type of
attachment, which is found against the natural tooth surface. The
most upper (coronal) zone of the hollow shell is a smooth,
non-textured surface, (FIG. 2, 302) which will inhibit plaque
adherence to the surface. It is conceivable that this surface will
be coated with an anti-microbial agent such as silver or a
hydrophobic agent to repel bacteria contact. The middle zone (band)
of the hollow shell is textured with vertical and oblique grooves
(FIG. 2, 304) that follow the peak to valley configuration of the
two other zones described. The grooves are separated by a distance
between 5-7 microns and are a depth of 10-20 microns. This textured
zone is 1 mm in height. A vertical and oblique grooves form a band
that in circles the perimeter of the hollow shell with a peak and
valley contour mimicking the upper (coronal) edge of the hollow
shell and this surface approximates the junctional epithelium of
the soft tissue socket and it has been found to encourage the
hemidesmosomal attachment of the junctional epithelium. It is
conceivable that a biologic agent, which layers a sol-gel
application as noted in this document to establish
adhesion/attachment of the junctional epithelium, is
anticipated.
[0112] The lower (apical) zone of the hollow shell is textured
(FIG. 2, 306) with a pitted-roughened surface with a diameter of 25
to 50 microns and 5 to 10 microns in depth for the surface texture.
The height of the zone is 2 mm and will approximate the
dento-gingival connective tissue and fibers of the residual
soft-tissue zone. This band of the hollow shell corresponds the
surface of the tooth (FIG. 11, 206) in which the dentogingival
fibers insert on the surface of the tooth. It is conceivable that
this zone of the hollow shell is coated with a biologically active
agent that produces proteoglycans and cementogenesis to further
encourage the dento-gingival fibers to insert into the surface. It
is understood that the surfaces of the hollow shell are not limited
to three distinct zones and could be one or more zones of any of
the surface textures described. It is understood that each zone
(band) of the hollow shell will follow the contour of the upper
(coronal) edge of the hollow shell structure with a peak and valley
shape reflective of the soft-tissue zone.
[0113] A further and more general object of the invention is to
provide a dental implant method and arrangement that uses a hollow
shell with outer bio-compatible surface for engaging a soft-tissue
socket that is left in gingival tissue after a tooth has been
extracted to promote healing by mechanically decoupling the shell
from an implant that has been fixed in the remaining bony socket,
the shell being tapered outwardly from a first to a second
perimeter, the second perimeter being asymmetrically scalloped with
opposite distal and mesial peaks and opposite lingual and facial
valleys between the peaks, the dental implant in the bone or bony
socket left after tooth extraction being rigidly connected to a
temporary post, the temporary post extending in the shell and a
luting compound filling the volume between the shell and the post
and setting solid for fixing the shell to the dental implant with
no other connection between the shell and the implant so that the
outer surface of the shell engages against the soft-tissue socket
without gaps and without requiring alignment of the shell and
implant axes.
[0114] The invention uses the shell as a biological seal enhanced
and promoted through the use of a biologically active surface for
both the soft-tissue socket and for the bony socket, to preclude
contaminants from the soft-tissue and from the bony sockets. The
biologically active agents may also retard the growth of
opportunistic pathogens at the interface. Namely, the addition of a
biologically active surface may also prevent the colonization of
bacteria and the like as well as reduce the inflammatory reaction
typically associated with host challenges. We anticipate that a
biologically active surface is also a surface that is defined to
prevent specific cellular proliferation and adverse outcomes. It is
conceived that the use of a biologically active surface includes a
particular surface texture, surface roughness, hydrophilic surface,
surface conditioning, macro- and micro-geometric pattern and/or
micro- and macro-morphological surface irregularities (as those
previously referenced and described above) to promote and prevent
specific cell populations from soft tissue attachment and/or
adherence. An example of this concept would be a biologically
active surface that will prevent the apical (downward) migration of
sucular epithelium onto the entire surface of the hollow shell. A
further example would be a biologically active surface that will
prevent an apical migration of the Junctional Epithelium onto the
surface of an immediate implant abutment that would otherwise be an
area with dentogingival fiber attachment. In conclusion, the hollow
shell with a biologically active surface is capable of controlling
selective cellular repopulation along its surface thereby promoting
a true re-attachment and/or adherence of the immediate soft-tissue
extraction site.
[0115] The present invention also includes another important
concept that the biologically active surface can also prevent
undesirable cellular attachment and/or adhesion in addition to the
general concept of preserving and promoting re-attachment.
[0116] As will be explained more fully in the following, the
present invention allows this placement of the properly sized and
shaped shell 10, in the soft-tissue socket, with complete freedom
of motion in the x-, y- and z-directions and, just as importantly,
with complete freedom of rotation about all three axes. This is
done by mechanically de-coupling the abutment that is formed by
this shell and the post 10, from the solid implant that must be
rigidly fixed in the bony socket at its own optimum angle and
depth.
[0117] A dental implant 30 having an implant axis 32 is provided
and is adapted for placement in the bone socket immediate after
tooth extraction, clearing and dressing of the bony socket in a
conventional manner, for example, by removing debris and drilling
an immediate implant receiving bore in the bone or bony socket
using known techniques.
[0118] The temporary post 40 is then rigidly connected to and is
coaxial with the dental implant 30, for example, by using a screw
50 that is inserted into a central bore in the post 40 and screwed
into a treaded bore in the top center of the implant 30. A head 52
engages an annular step in the post 40 in a known manner, to fix
the post 40 to the implant 30. The temporary post 40 extends in the
interior volume of the hollow shell 10 but is not yet connected to
the shell, and need not even touch the shell, so that despite the
fixing of the post to the implant, the shell can be engages to the
soft-tissue socket without directional or rotational
limitation.
[0119] An initially fluid luting compound is filled into the
interior volume between the shell 10 and the temporary post 40 and
is allowed to set solid. Only then is the shell 10 fixed to the
dental post 40 and implant 30, with no other previous connection
between the shell and the implant so that the outer surface of the
shell engages against the soft tissue socket without gaps and
without requiring any alignment between the shell axis 12 and the
implant axes 32.
[0120] As shown in FIG. 12, with shell 10 is seated in soft tissue
socket 108 immediately after a tooth is extracted from and the
shell seals the bone socket 106 in the jaw bone 112.
[0121] As illustrated in FIG. 2 the lingual valley 24 is lower than
the facial valley 26 for mimicking maxillary and mandibular
incisors for example. For mimicking maxillary and mandibular
canines, the valleys 24 and 26 can be of substantially equal in
height. For premolars and molars, the opposite of incisors is true
so that as shown in FIG. 3 the lingual valley 26 is higher than the
facial valley 24 and mesial and distal peeks 20 and 22 are not as
highly scalloped as in incisors.
[0122] FIG. 2 also illustrates three different surface treatments
for the three zones of the soft tissue socket.
[0123] Methods and Procedures of the Invention:
[0124] The method of the invention permits immediate implant
soft-tissue abutment temporary placement at the time of tooth
extraction to re-establish an effective biologic-seal of the
soft-tissues to the surface of the abutment or shell more
effectively to its anatomic shape.
[0125] The Immediate Implant Soft-Tissue Abutment Temporary May
be:
[0126] 1. An immediate soft-tissue implant abutment temporary
extending from the crest of bone 112 to the height of the remaining
soft tissues 110. The immediate soft-tissue abutment temporary will
re-establish a biologic-seal preserving the gingival soft tissues
after the removal of a tooth and the immediate placement of an
implant. It also enables containment of bone regenerative materials
and primary coverage of the barrier membrane if used after tooth
removal; and/or
[0127] 2. An immediate tooth-form implant temporarily
re-establishes a biologic-seal preserving the gingival soft tissues
after the removal of a tooth and the immediate placement of an
implant. It also enables containment of bone regenerative materials
and primary coverage of the barrier membrane if used after tooth
removal.
[0128] The immediate implant soft-tissue abutment temporary is a
temporary component that connects to the implant-platform (superior
surface of the implant platform) at the bone crest and extends to
the level of the free-gingival margin of the soft tissue. It
provides the necessary shape and adaptation to re-establish a
biologic-seal between the soft-tissues and the surface of the
temporary with a biologically active surface. The outer surface may
be one or more different combinations of biologic agents, creating
of a macro- and micro-geometric pattern and/or micro- and
macro-morphology surface irregularities (as those previously
referenced and described above).
[0129] The Immediate Implant Soft-Tissue Abutment Temporary, I.e.
Shell 10, Method has the Following Features or Steps:
[0130] 1. The method and device in the preferred embodiment use a
surgically sterile surface for shell 10 with a bi-layer
micro-texture to promote immediate soft-tissue repair and
adaptation promoting re-attachment or repair to the biologic
surface. It is anticipated that the surface may have a regular
micro-geometric pattern that is uniform. It is also anticipated
that the surface texture may be modified chairside using a rotary
instrument such as a uniquely designed dental bur, that results in
a ordered microgeometric repetitive surface pattern in the form of
alternating ridges and grooves, each having an unfixed width in a
alternating range of about 2.0 to about 25 microns (micrometers)
and a nonfixed or altering depth in a range of about 10 microns to
about 50 microns, in which the microgeometric repetitive patterns
define a guide soft-tissue preservation and re-attachment of soft
tissue fibers to the surface of the immediate implant soft-tissue
temporary abutment.
[0131] 2. The shell is hollow and is of generally tubular design to
accommodate the position of an immediate root-form implant 30
positioned at multiple locations within the residual socket.
[0132] 3. The method and device provides an immediate mechanical
seal between the residual soft tissue socket and the surface of the
immediate implant soft-tissue temporary (Provisional) abutment.
[0133] 4. The method and device promotes cellular soft-tissue
attachment and/or adherence to the biologically active surface of
the immediate implant soft-tissue temporary (Provisional)
abutment.
[0134] 5. The method and device retards cellular soft-tissue
attachment and/or adherence to the biologically active surface of
the immediate implant soft-tissue temporary (provisional)
abutment.
[0135] 6. The method and device preserves the soft-tissue
architecture of the gingival surrounding the immediate implant
soft-tissue temporary (Provisional) abutment.
[0136] 7. The method and device enables bone regenerative materials
to be retained in any gap left around the top of the implant 30,
and protected during initial healing but the shell, in effect,
sealing this area from the outer end of the soft and bony
sockets.
[0137] Critical to the design is creating an effective biological
socket-seal between the surface of the abutment-temporary
(provisional) to adequately support and seal the residual soft
tissue socket at the time of placement. The subgingival shape of
the temporary shell promotes biological socket seal by providing
either an over-contoured or under-contoured emergence profile to
compensate for the position of the dental implant.
[0138] Additionally, the abutment-temporary design provides a
single uniform material within the soft tissue zone of the residual
soft tissue socket that prevents a micro- and macroscopic gap
between dissimilar materials in the soft tissue gingival zone.
[0139] The abutment-temporary subgingival emergence profile
provides an over-contoured or under-contoured shape that is
anatomical to compensate for the three dimensional position of the
underlying endosseous implant spatial position.
[0140] The abutment-temporary dental implant prosthesis is designed
to be an interim prosthesis that is fabricated chair-side and is
customized to provide individual unique tooth replacements. The
temporary shell is designed from a series of elliptical and
asymmetric shapes that have an eccentric opening for access to
accept a cylindrical component that is attached via a screw
mounting to the dental implant.
[0141] A self-curing material is used to affix the shell to a
screw-retained temporary post 40 during the chairside fabrication
of the abutment-temporary. The abutment-temporary (provisional) is
modified chairside to generate a unique final shape and provide an
adequate seal between the abutment-temporary (provisional) and the
soft tissue socket. Preformed non-concentric elliptical shells
provide a matrix to fabricate the abutment-temporary dental implant
restoration.
[0142] The immediate abutment-temporary, that can also be thought
of as an immediate provisional abutment, has one interface region
between the dental implant and the overlying abutment-temporary.
The interface is at the level of the implant buccal plate and
contained at the level of bone crest. This eliminates the micro-
and macroscopic gap from being positioned within the soft tissue
zone of the soft tissue residual socket for immediate implant
placement into a fresh extraction site.
[0143] Description of Methods:
[0144] It is understood in the description of the method and device
that the placement of an immediate soft-tissue preservation implant
abutment has the intended use for the extraction and replacement of
a single tooth or multiple teeth. The method will describe for a
single tooth, but it is understood that the deception of the method
and device is note limited to a singular tooth but implies a
description for multiple teeth as additional embodiments of the
invention.
[0145] It is understood in the general description of the method of
application of the device that the hollow shell will be placed at
the time of the removal of a tooth and at immediate placement of a
dental implant. It is understood that the hollow shell will serve
as a temporary abutment for a period of time immediately following
the removal of the tooth. The temporary abutment is placed
immediately upon tooth removal and approximates the entire surface
of the soft-tissue without gaps between the surface of the hollow
shell and the connective tissue. This allows the gingival tissue to
re-establish the adherence/attachment that was present prior to
removal of the tooth thus preserving the contour of the papilla and
gingiva. It is understood that this newly formed connection of the
surface of that hollow shell and the connective tissue will be
disrupted and disturbed upon the placement of the final implant
abutment and implant crown prosthesis. This is not of critical
consequence as the long as the subsequent prosthesis is placed
immediately after removal. It has been found that a minimally
invasive technique followed by immediate placement of either the
temporary abutment and/or final implant abutment results in a
minimal disruption to the tissues. It is conceived that the final
implant abutment prosthesis will have the same shape, contour and
texture as the temporary abutment that was used. This will then
allow the soft-tissue zone to re-establish to the newly placed
final implant abutment and restoration. The placement of the final
implant abutment will be inserted immediately upon the removal of
the temporary abutment to ensure that tissue changes and remolding
does not occur. It is conceivable that a temporary implant abutment
is fabricated via a CAD/CAM technology so that it will become the
final prosthesis and not require removal after placement. It is
conceivable that the CAD/CAM temporary abutment will possess all of
the contour, shape and textures previously described.
[0146] It is understood that the immediate placement of both the
temporary and final prosthesis is critical to prevent the
soft-tissue zone from healing with scare formation and/or remolding
of the connective tissues. Immediate placement of both the
temporary and final implant abutment with a minimal invasive
technique herein described preserves the soft-tissue zones of the
sulcular epithelium, junctional epithelium and dento-gingival
fibers. It is contra-indicated to use a delayed approach for either
the temporary or final abutment prosthesis as this will promote
wound healing that has been shown to result in epithelum covering
the entire wound with a remoldening of the tissues losing the peak
to valley natural contour. A delayed approach often results in
scaring and adaption of the soft tissues and a re-arrangement of
the three zones which have been detailed within this description.
Therefore, the placement of both the temporary and final prosthesis
immediately after the removal of either the tooth or temporary
implant abutment is critical to the health and preservation of the
soft-tissue zone. The temporary element to immediate implant is
another factor which distinguishes this method with all other
previously described methods and techniques. The structural
configuration of three zones within the soft-tissue zone upon the
hollow shell following a peak and valley configuration is also
important to the maintenance and re-establishment of a biologic and
functional attachment of the supra-crestal soft-tissue zone.
[0147] The diagnosis that a tooth requires extraction is determined
by the dental clinician. The diagnosis is preformed using
conventional means including clinical examination, radiographic
analysis, detailed past dental history and the review of signs and
symptoms. The patient is informed of the treatment alternatives and
an appropriate informed consent to treatment is provided to the
clinician.
[0148] Prior to the extraction of the tooth a clinical photo can be
taken to allow future comparison of the pre-treatment condition
that was present versus the post-operative outcome after treatment
is completed. The photo may have a reference measurement tool or
instrument so that detailed analysis of the soft-tissue changes can
be analyzed.
[0149] A Dental impression either using conventional impression
materials such as alginate, polyether, vinyl polysiloxane, and
other materials to establish an accurate representation of the
teeth and surrounding gingival tissues. It is understood that the
described embodiment may also be performed using a digital
impression such as cone beam computer tomography or digital oral
impression (CAD/CAM Digital Impressions) using a hand-held oral
scanning device of known design.
[0150] The area of the mouth in which the tooth is to be extracted
is anesthetized with a dental local anesthetic solution. A local
anesthetic solution is can be delivered to the area either as local
infiltration dental injection or as a regional nerve block to the
area. The patient is given adequate time (typically 5 minutes) for
the dental local anesthetic to anesthetize the region of the mouth
that is being treated.
[0151] Extreme care is used to preserve the entire tissue-zone and
minimize trauma to the supporting gingival tissues during each
phase of treatment. It is critical to preserve the soft-tissue
architecture of the immediate and surrounding gingival in order to
re-establish the biologic-seal after the tooth is removed and the
immediate soft-tissue implant abutment, i.e. shell 10, is placed.
Therefore a flapless surgical technique is used.
[0152] The first step to performing this method is to carefully
incise the entire supra-crestal attachment of the tooth 360 degrees
around the tooth, i.e. around soft tissue socket. It is important
to surgically disconnect the soft-tissue attachment fibers. This
can be accomplished using a surgical blade, piezo-surgical
instrument, micro-rotary dental handpiece or dental laser
soft-tissue cutting instrument. The method requires careful
dissection of the supra-crestal attachment which includes the
sucular epithelium, junctional epithelium, connective tissue
inserting fibers which are found between the connective tissue and
the surface of the root above the crest of bone. Once the
supra-crestal fibers are released the superior periodontal ligament
fibers (attachment fibers found between the alveolar bone socket
and root surface) can next be incised.
[0153] The superior periodontal fibers attach the surface of the
tooth (cementum) to the inner bony socket must also be severed
using minimal disruption to the surrounding soft-tissue and bony
architecture. This can be accomplished by using micro-surgical
instruments, periotomes, a rotary diamond pointed diamond,
piezeo-surgical instrument, laser. It is important that the
instrument diameter is between approximately 20 microns to 50
microns (or 1/8 to 1/4 millimeter in diameter) as this is the
dimension of the width of the periodontal ligament space. The
surgical instrument is placed into the entrance of the periodontal
ligament between the tooth and inner socket wall. The periodontal
attachment fibers are served around the tooth to a depth of 1 to 4
mm, depending on ease of entry into the periodontal ligament
space.
[0154] The extraction of the tooth is first initiated using a
rotational movement in order to severe the remaining subcrestal
periodontal fibers attaching the tooth to the inner socket wall.
This can be performed with either using a reduced diameter
elevator, periotome or extraction forceps. Once a rotational
movement is achieved a vertical force can be applied to the tooth
to advance the root out of the bony socket.
[0155] When the extraction is performed using this method minimal
disruption can occur to the surrounding soft-tissues of the
gingival. The interdental papillae are not surgically altered from
the pre-treatment condition. Incisors are not made which compromise
the blood supply to the region of the bone or surrounding
soft-tissue gingival. The architecture of the soft-tissue has not
be altered other than the severing of the attachment fibers between
the root surface and inserting fibers.
[0156] Removal of any inflammatory granulation tissue within the
bony socket may be necessary. This is performed using a small sized
circular curette. Inspection is performed to ensure the integrity
of the remaining inner socket walls. A radiograph may be taken to
determine the remaining configuration of the tooth socket. This
step is referred to here as preparing the bony or bone socket.
[0157] Immediate insertion of dental implant 30 is performed. A
dental implant is immediately placed within the residual extraction
socket. The term "immediately" as used here means that the implant
is placed shortly after the bony socket has been fully prepared to
receive the implant, 10 to 30 minutes for example, but importantly
during the same patient's visit.
[0158] The vertical position of the implant: The implant 30 can be
placed at the level of the remaining crest of bone. Since the
remaining crest of bone has different heights the implant may be
slightly supra-crestal as one region and slightly subcrestal at
another region of the socket, this is to be expected.
[0159] The horizontal position of the implant: The implant is to be
ideally placed with the axial position allowing for a
screw-retained temporary. The center axis of the implant must
therefore be placed in the position of the cingulum of the adjacent
teeth; i.e., positioning the implant toward the palatal (lingual)
aspect of the residual extraction socket. It is noted that the
implant 30 will not be placed in the center of the socket 102 as
this would result in the retention screw of the immediate-temporary
to exit through the incisal edge of the tooth and will result in an
esthetic compromise of the restoration. Positioning the implant
biased toward the palatal (lingual) position of the extraction
socket is critical so that a screw-retained immediate temporary
restoration can be used. This advantageous placement of the implant
is made possible by the fact that the abutment or shell 10 of the
invention is mechanically de-coupled from the implant and need not
be affixed with respect to the axis or position of the implant as
has been common in the past. The preferred embodiment of the
invention is an immediate screw-retained temporary to eliminate the
need for cementation of the temporary. Retention of the immediate
temporary relies upon mechanical retention of the screw. It is
anticipated that the immediate temporary could be designed in with
a temporary design in which it is cemented to the substructure
directly and places the location of the micro gap below the soft
tissue zone.
[0160] The immediate implant 30 must mechanically engage and lock
into a portion of the remaining bone. This may be achieved at the
apical end of the implant. It may also be achieved on a lateral
portion of the surface of the implant.
[0161] It is understood that the implant diameter will be smaller
then the greatest diameter of the root of the tooth that was
removed. Therefore the dissimilar diameters between the immediate
implant and the residual bony tooth socket must result in a "gap"
or space between the residual bony socket and the surface of the
implant 30. Filling the entire tooth socket is not desirable, as
this method relies upon a residual gap between the facial surface
of the immediate implant and the remaining buccal plate of bone.
This gap will then allow for the placement of a bone regenerative
material to be placed between the implant surface and the inner
tooth socket buccal plate. The gap allows for future bone
regeneration via the in growth of the blood supply and new
osteoblasts. It is important not to use a implant diameter that
would make direct contact to the labial plate of bone as this would
compromise the blood supply that is needed to preserve the labial
(buccal) plate of bone as the implant surface provide no ability
for angiogenesis. This is critical point to appreciate and
understand. The preservation of the overlying gingival and
surrounding soft-tissues is preserved by several critical factors:
(1) a minimally invasive surgical approach; (2) preservation
soft-tissue architecture; and (3) preservation and promotion to
re-establish the blood supply to the surrounding tissues.
[0162] Placement of the immediate soft-tissue implant preservation
abutment shell with a biologically active surface involves a
screw-retained temporary post 40, such as the PreFormance Post from
Biomet 3i Dental Implants of Palm Beach Gardens, Fla., is connected
to the dental implant 30 held within the bone. The immediate
soft-tissue abutment shell 10 is selected for the proper vertical
and horizontal dimensions. The immediate soft-tissue preservation
abutment shell 10, as noted above, is supplied in different
dimensions depending upon the tooth to be replaced. It will have
series of defined dimensions externally. These dimensions will
include a series of different tissue-zone heights ranging from 2 mm
to 5 mm. It will be provided in several root form configurations
and be provided in more then one horizontal widths. An example of
the horizontal dimensions could be, but not limited to:
[0163] Maxillary Right Central Incisor: [0164] Height 2 mm, Height
3 mm, thru 5 mm. [0165] Diameter, Small, Medium and Large. [0166]
An irregular superior surface is provided to conform to the
soft-tissue gingival architecture. The interproximal points will be
longer in dimensions then the labial and lingual surfaces. [0167]
The inner shell allows for the eccentric position of the shell over
the center axis of the implant held within the bone.
[0168] Maxillary Right Lateral Central Incisor: [0169] Height 2 mm,
Height 3 mm, thru 5 mm. [0170] Diameter, Small, Medium and Large.
[0171] An irregular superior surface is provided to conform to the
soft-tissue gingival architecture. The interproximal points will be
longer in dimensions then the labial and lingual surfaces. [0172]
The inner shell allows for the eccentric position of the shell over
the center axis of the implant held within the bone
[0173] Maxillary Right Canine: [0174] Height 2 mm, Height 3 mm,
thru 5 mm. [0175] Diameter, Small, Medium and Large. [0176] An
irregular superior surface is provided to conform to the
soft-tissue gingival architecture. The interproximal points will be
longer in dimensions then the labial and lingual surfaces. [0177]
The inner shell allows for the eccentric position of the shell over
the center axis of the implant held within the bone.
[0178] Maxillary Left Central Incisor: [0179] Height 2 mm, Height 3
mm, thru 5 mm. [0180] Diameter, Small, Medium and Large. [0181] An
irregular superior surface is provided to conform to the
soft-tissue gingival architecture. The interproximal points will be
longer in dimensions then the labial and lingual surfaces. [0182]
The inner shell allows for the eccentric position of the shell over
the center axis of the implant held within the bone.
[0183] Maxillary Left Lateral Central Incisor: [0184] Height 2 mm,
Height 3 mm, thru 5 mm. [0185] Diameter, Small, Medium and Large.
[0186] An irregular superior surface is provided to conform to the
soft-tissue gingival architecture. The interproximal points will be
longer in dimensions then the labial and lingual surfaces. [0187]
The inner shell allows for the eccentric position of the shell over
the center axis of the implant held within the bone.
[0188] Maxillary Left Canine: [0189] Height 2 mm, Height 3 mm, thru
5 mm. [0190] Diameter, Small, Medium and Large. [0191] An irregular
superior surface is provided to conform to the soft-tissue gingival
architecture. The interproximal points will be longer in dimensions
then the labial and lingual surfaces. [0192] The inner shell allows
for the eccentric position of the shell over the center axis of the
implant held within the bone.
[0193] It is understood that each shells 10 can be for the specific
tooth being replaced. The dimensions of the shell are based on
measurements of numerous soft-tissue sockets remaining after tooth
removal. The shell 10 has the requirement to enable a soft-tissue
socket-seal to be re-established. This is predicated upon allowing
the proper dimensions to completely fill the soft-tissue
(tissue-zone) socket.
[0194] In general terms and from observation of stone casts and
extracted teeth as well as descriptions, pictures and illustrations
in Dental Anatomy book, it seems that the "lingual valleys" are
lower than "facial valleys" in maxillary and mandibular incisors.
Max. and mand. canines "valleys" are of about equal height. Max.
and mand. premolars and molars seem the opposite of incisors where
"lingual valleys" are higher than "facial valleys" and mesial and
distal peeks are not as highly scalloped as in incisors. Of course
there are always exceptions and slight variations to the rule since
each person dental anatomy will vary.
[0195] The preferred embodiment of the immediate soft-tissue
implant preservation abutment shell is generally defined as a
"tubular shell" which is open at both ends at perimeters 16 and 18.
The inferior is placed into the soft-tissue socket to make direct
contact with the implant head platform of the implant 30 within
bone 112. The superior surface is to approximate the free-gingival
margin of the surrounding tissue-zone. The outer surface of the
shell 10 is to make direct contact with the inner soft-tissue
residual socket. The outer surface composed of a bioactive surface
that is defined by but not limited to, a particular surface
texture, surface roughness, hydrophilic surface, surface
conditioning by applying bio-active agents, creating of a macro-
and micro-geometric pattern and/or micro- and macro-morphological
surface irregularities (as those previously referenced and
described above) to promote soft tissue attachment and/or adhesion
of the dentogingival complex.
[0196] It is anticipate that this biologically active surface may
also retard the growth of pathogens and/or specific cell types
during healing of the soft-tissue socket. It is also conceivable
that the biologically active surface will control and regulate
selective cell repopulation along the surface of the hollow shell
from the application of the biologic agent to said surface. The
final adapted shell eliminates all openings and gaps between the
soft-tissue socket and surrounding gingival. This re-establishes a
biologic-seal to the underlying tissues below the surface. This
will also provide containment and protection of any bone
regenerative materials that are placed between the surface of the
bone socket and the surface of the implant filling the "gap"
between the dissimilar diameters of these two structures. If
necessary a membrane can be placed at the level of the bony crest
and placement of the shell 10 will provide complete coverage of the
membrane below providing a biologic-seal to the outer oral
environment. Once the shell is filled (see step 10 below) and
modified it will also provide structural support to the soft-tissue
gingival to prevent and preserve the architecture. The surface of
the immediate abutment shell promotes soft-tissue adhesion to the
surface. Allowing the superficial layers of the dermis to adhere to
a smooth superior region of the abutment shell as well as
encouraging functional fiber orientation to the roughened inferior
region to promote a functional connective tissue attachment.
[0197] Luting (chair-side connection) of the immediate soft-tissue
implant preservation abutment shell to the retaining screw-post of
the implant: Once the proper abutment shell is selected from the
variety of sizes and diameters it is placed within the tissue-zone
soft-tissue socket. It is eccentrically positioned to the implant
as previously described so that the outer surface of the shell make
physical contact ensuring a biologic-seal between soft-tissue and
surface of the shell. It is luted or connected to the screw-post in
this position by using a chairside technique. The technique of
connecting the shell 10 to the screw-post 40 can be performed with
a variety of materials in the preferred embodiment a cold-cure
acrylic is used, in additional embodiments any number of
polymerization materials can be used but not limited to composite,
acrylic, resin, etc. The entire internal surface of the shell 10 is
filled with luting compound and eliminating voids or gaps within
the material.
[0198] The superior surface can be filled to the level of the free
gingival margin. An access hole will remain to allow removal of the
shell, e.g. but inserting a nylon plug into the central hole of the
post 40 for final finishing and temporary insertion.
[0199] The inferior surface is modified and any gap or voids are
filled chair-side and then re-surfaced as described below.
[0200] Re-surfacing of the shell material, preparation and
handling: In certain situations it may be necessary to modify the
shape and surface of the shell 10 to properly adapt to the soft
tissue socket. An additive technique of material or subtractive
technique can be required in which additional materials or added or
removed. To resurface the modified outer shell a novel surface
texture bur is attached to a standard rotary handpiece. This
preservation abutment shell bur is designed to re-establish the
surface texture that was created in the texture zone on the outer
surface of the abutment shell. It is conceivable that the
application of the biological agent will be applied at the time of
placement of the hollow shell into the extraction socket. This
includes but not limited to a chairside application of a specific
biologically active agent upon the outer surface of the hollow
shell. A second (or third) step of cleaning may then require
removal of all contaminants. This surface cleaning step is
accomplished by thorough cleaning, in the preferred embodiment this
can require high-pressure, high-heat steam cleaning in alternative
embodiments it is anticipated that autoclave, antimicrobial
cleaning solutions may be applied to the surface to detoxify the
contaminated surface.
[0201] After filling and reshaping of the shell 10 is completed it
is removed from the implant by un-screwing the retaining screw 50.
The abutment shell is then cleaned and inspected and all voids are
filled and re-surfaced and cleaned as described above.
[0202] Placement of a standard cylindrical healing abutment is
attached to the plate-form. The standard cylindrical healing
abutment may be composed of titanium, stainless steel, anodized
metal or other metal. It is conceivable that the standard
cylindrical healing abutment is made from a cost saving polymer and
disposed of after removal as this component is to be used as an
intra-operative space maintaining during the placement of bone
regenerative materials during this method. The standard healing
abutment is selected to attach to the implant resulting with a
noticeable gap between the outer surface of the standard
cylindrical healing abutment and the soft-tissue socket. Bone
grafting materials are placed within the gap between the bony
socket and surface of the implant 30 at or below the crest of bone.
An optional barrier membrane can be positioned if necessary before
or after the bone grafting materials being put into placed.
[0203] The standard cylindrical healing abutment is removed and
discarded and the contoured refinished abutment inserted. In the
preferred embodiment the retaining screw is put into placed and
applying a seating torque to the screw that is between 15
newton-centimeters to 35 newton-centimeters.
[0204] The abutment shell 10 is adjusted to ensure that it is not
in occlusal contact with the opposing teeth when the patient closes
their mouth.
[0205] A final radiograph is taken to assess the fit and position
of the implant and shell.
[0206] The abutment shell 10 creates a biologic-seal to the
underlying soft tissue and preserves the integrity of the
surrounding gingival architecture. The abutment shell 10 is not to
be removed for a minimum of 3-4 months at which time the
fabrication of the final prosthesis can be initiated.
[0207] Further Structural Details of the Invention:
[0208] As noted, illustrated and described above, abutment shell 10
in its preferred form, is generally a tubular shell which is open
at both ends. The tubular shell has the following specifications
but it is anticipated that it may also have other designs
features:
[0209] The shell is an irregular tubular design that mimics the
shape of residual soft-tissue (tissue-zone) socket that remains
after a tooth has been removed. Examples of these shapes (generally
occlusal views) are provided in FIGS. 2-5. The shape may more
closely mimic the cross-sectional outline of a root in the
tissue-zone region, but may also be designed to over-compensate on
one or more surfaces to ensure physical contact along all aspects
of the soft-tissue tooth socket. It is critical that the shell's
fit with contact and not be causes excessive contact pressure at
any specific point or area of the soft-tissue socket.
[0210] Outline shape of the two ends of the preservation abutment
shell 10 is irregular as also illustrated in the drawings. The
superior (gingival) surface of the shell (at outer perimeter 18)
has a larger area when compared to the inferior (implant) surface
(at inner perimeter 16) that comes into contact with the platform
head of the implant 30.
[0211] The vertical height of the tubular shell will not be
uniform. The interproximal surfaces at peaks 20 and 22 have a
greater height when compared to the buccal and lingual surfaces at
24 and 26 of the tubular shell 10.
[0212] The emergence profile of the shell is one that has a variety
of profiles to compensate for the position of the implant within
the residual socket. Since the implant is to be intentionally
placed off-center from the extracted tooth, the shell is
intentionally placed eccentric to the immediate implant 30, placed
within the bone. The shell is designed to be placed eccentric to
the implant head. The emergence profile of the shell is
over-compensated and under-compensated in the profile design
allowing for the position of the implant. The compensating
emergence profile design and ability to place the shell eccentric
enables the re-establishment of an effective biologic-seal between
the outer surface of the shell and the residual soft-tissue
perimeter. The shell can be confined to the transmucosal
(tissue-zone) region extending from the crest of bone to the free
gingival margin or it may continue to extend into the oral cavity
as the labial surface of material to replace the labial surface of
the removed tooth in addition to the transmucosal region.
[0213] Surface Texture and morphology of Shell--In the preferred
embodiment the outer surface text design can possess three distinct
surface texture zones or bands which follow the contour of the
peaks and valleys of the upper (coronal) edge of the hollow shell
(FIG. 2). These three different bands are distinct from one another
and run parallel to the coronal edge of the hollow shell and to one
another, FIG. 2 at zones 302, 304 and 306. The upper (coronal) band
of the hollow shell can be smooth to discourage the accumulation of
plaque, 302. The smooth band extends 1 mm to 3 mm vertically and
corresponds to a region found on a tooth as depicted in FIG. 11,
202. This region on a tooth is a scalloped, circumference band
(302) of the tooth in contact with the sulcular epithelium. It is
preferable that the surface be smooth to minimize the accumulation
of plaque and bacteria as seen in FIG. 2 at 302. After placement
and healing of 10 into the mouth of a patient, the smooth surface
of 302 approximates the sulcular epithelium of the gum, FIG. 12 at
302, and can be effectively cleaned and maintained in a state of
health as this surface can is easily cleaned do to the smooth
surface.
[0214] The middle band of shell, FIG. 2 at 304 is the zone of the
hollow shell that approximates the junctional epitheialium
corresponding to the region on the tooth, FIG. 11 at 204. This band
extends 0.25 mm to 1.35 mm vertically. The middle band of the
hollow shell is textured with vertical and oblique grooves, FIG. 2
at 304 and forms a circumferential band around the hollow shell as
do all three bands herein described. This middle band follows the
peak to valley configuration of the two other zones described. The
grooves are separated by a distance between 5-7 microns and are a
depth of 10-20 microns. This textured zone is 0.25 to 1.35 mm in
height possesses an ordered microgeometric repetitive surface
pattern. This band corresponds to the region on the tooth, FIG. 11
at 204 in which the Junctional Epithelium of the gum attaches to
the tooth via the hemidesmosome attachment. After placement and
healing of 10 into the mouth of a patient, the vertical and oblique
grooves of surface of 304 approximates the junctional epithelium of
the gum, FIG. 12 at 304, and provides a surface to which the soft
tissue can establish adherence of the junctional epithelium to the
surface of the shell to create a functional barrier and seal
resulting in a state of health.
[0215] The inferior (apical) textured band of the hollow shell
(FIG. 2, 306) covers the remaining outer surface. This textured
surface encourages the re-establishment of the gingival fibers to
make contact and adhere to the surface of the temporary abutment.
This band of the hollow shell is textured with a pitted-roughened
surface (FIG. 2, 306) with a diameter of 25 to 50 microns and 5 to
10 microns in depth for the surface texture. This band measuring 1
mm to 3 mm in vertical height. This apical band follows the peak
and valley contour of the other two bands on the coronal aspect,
while the inferior aspect follows the contour of the apical edge of
the hollow shell, FIG. 2. The surface of the inferior band of the
hollow shell approximates the dento-gingival fibers seen in FIG. 12
at 306, this corresponds to the region of the tooth that is
attaches to the dento-gingival fibers of the tooth, FIG. 11 at 206.
After placement and healing of 10 into the mouth of a patient, the
micro-pitting and roughened surface enables the dentogingival
fibers to insert directly into the surface of the shell producing a
stable functional gingival attachment to this region of the hollow
shell, FIG. 12 at 306. It is conceivable that this band of the
hollow shell is coated with a biologically active agent that
produces proteoglycans and cementogenesis to further encourage the
dento-gingival fibers to insert into the surface.
[0216] The surface texture is not limited to two or more texture
patterns, it is conceivable that the surface of the shell be design
with a single texture covering the entire surface or designed from
multiple textures to encourage direct soft-tissue adaptation within
the tissue-zone. A smooth surface at the superior regions
discourages plaque accumulation while the textured surface promotes
and accelerates effective soft-tissue adhesion. The surface design
discussed in the preferred embodiment has been shown to promote
soft-tissue preservation in combination with providing an effective
biologic-seal of the surface of the shell to the residual soft
tissues. A bioactive surface that is defined by but not limited to,
a particular surface texture, surface roughness, hydrophilic
surface, surface conditioning by applying bio-active agents,
creating of a macro- and micro-geometric pattern and/or micro- and
macro-morphological surface irregularities (as those previously
referenced and described above) to promote soft tissue attachment
and/or adhesion of the dentogingival complex.
[0217] Material--the shell can be composed of a variety of
biocompatible materials including but not limited to; ceramic,
acrylic, porcelain, lithium disilicate, zirconia and other
crystalline structure. It is anticipated that this material can be
composed of materials that are anti-microbial, bacteriostatic to
retard the growth or colonization of the surface and internal
surfaces with micro-organisms. Examples of such materials include
but are not limited to; silver, copper, magnesium, titanium,
hydroxyapitite, etc. These materials can be incorporated into the
shell material or may be applied to the shell surface forming a
second layer.
[0218] The connection interface of the abutment shell is placed at
the level the implant head platform. In the preferred embodiment
there is a single interface at the implant plate-form at the bone
crest level. This interface is a mechanical connection to minimize
the placement of a micro- or macro-connection gap within the
tissue-zone. The preferred embodiment is screw-retained. It is
anticipated that a cementable version of the immediate soft-tissue
implant preservation abutment shell can be fabricated.
[0219] The preferred embodiment of the shell is confined to the
tissue-zone, but it is anticipated that a second design could
include part of all of the tooth form that was extracted.
[0220] A tooth-form temporary (not shown) that is selected or
created to match the extracted tooth, is then luted to the outer
perimeter 18 of shell 10 so that the patient leaves with a
cosmetically equivalent tooth replacement to the one extracted.
[0221] Disposable Standard Cylindrical Implant Intra-Operative
Abutment:
[0222] This component is used as intra-operative abutment that is
placed during the immediate soft-tissue implant preservation
protocol to allowing bone grating materials to be placed within the
bone gap between the implant surface and the bony residual socket.
It also has the function to prevent bone grafting materials from
entering into the internal screw hole of the implant prior to the
placement of the immediate soft-tissue implant preservation
abutment. It is a single use, disposable component. It can be
fabricated from a variety of materials and come in a variety of
heights and widths. The preferred embodiment is an inexpensive
polymer material allowing it to be screwed or press-fitted into
place during the placement of the bone grafting materials.
[0223] Immediate Soft-Tissue Abutment Texturing Bur:
[0224] This component is a rotary bur that is designed to provide a
microgeometric repetitive surface pattern forming a varying widths
and varying depths ranging from 10 microns to about 50 microns. The
irregular repetitive pattern is created using a chair-side rotary
instrument on the surface of the immediate soft-tissue implant
preservation abutment to resurface the outer shell.
[0225] Immediate Soft-Tissue Abutment Application of a Biologic
Agent Upon the Outer Surface of the Hollow Shell:
[0226] The application may be applied chairside and at the time of
tooth removal. It is conceivable that the biologic active surface
is incorporated into the outer surface of the hollow shell and/or
applied to the outer surface prior to the time of tooth removal.
The surface may be composed of one or more biologic agents.
[0227] Improvements Over Prior Art:
[0228] Following are some improvements of the invention over known
implant apparatuses and methods:
[0229] Preservation of the soft tissue architecture after the
immediate removal of a tooth.
[0230] Support of the soft tissues to prevent collapse of bone and
soft tissue during healing.
[0231] Creation a soft tissue "seal" of the replacement temporary
to the overlying soft tissues. A soft tissue seal of the residual
soft-tissue socket of an extracted tooth in which an immediate
implant has been placed.
[0232] Produce soft tissue adhesion by providing direct physically
contact between the prosthesis and surrounding soft tissue
socket.
[0233] Placement of a single interface between implant and
prosthesis that is below the soft tissue proximal heights at or
below the level of supporting bone.
[0234] One-piece prosthetic design that is a temporary that is
screw retained.
[0235] Prosthesis emergence profile is over-contoured to provide an
adequate soft-tissue seal and soft-tissue support to the soft
tissues to preserve the natural architecture of the gingival
tissues.
[0236] Prosthesis is under-contoured to provide an adequate soft
tissue seal between prosthesis and soft tissue socket to support
the soft tissues to preserve the natural architecture of the
gingival tissues.
[0237] The supra-gingival contour of the tooth prosthesis is
identical to the natural tooth while the sub-gingival possesses a
emergence profile contour that is either over-contoured or
under-contoured to compensate for the lack of ideal position of an
implant in the vertical, horizontal, and buccal-lingual,
mesial-distal angulations.
[0238] Anti-Rotational Prosthesis Screw-Retained Temporary
Prosthesis.
[0239] Anti-Rotational Features in the Implant/Abutment
Connection.
[0240] The temporary abutment is constructed directly chair-side
utilizing a prefabricated series of anatomic shells who's central
access is eccentric to allow either an over-contoured or
under-contoured subgingival emergence profile thereby allowing
adequate support of the soft tissue and ensuring a seal being
formed between the soft tissue socket and the temporary
prosthesis.
[0241] The temporary abutment is anticipated to prefabricate in a
variety of sizes and elliptical shapes of the root surfaces.
Different vertical heights will be provided. The shapes will be
designed to represent replacement of an extracted tooth.
[0242] Antimicrobial Surface and/or Material to be Used.
[0243] Incorporation of a microtexture on the surface of the
temporary that has a regular geometric configuration to encourage
soft-tissue connection.
[0244] Use of a specialized bur that creates a regular pattern on
the surface of the temporary.
[0245] The Following Designs are Anticipated, but not Limited
to:
[0246] Temporary transmucosal (root form) implant temporary shell
root form in the soft-tissue zone from the platform head of the
implant to the free-gingival margin.
[0247] The superior 1-3 mm may be smooth surfaced to provide a
plaque free zone.
[0248] Inferior surface (below the 1-3 mm plaque zone) may be
textured to encourage soft tissue adhesion.
[0249] Surface Treatment of the Shell by Steam Cleaning
[0250] The transmucosal temporary component of the invention makes
the physical and structural connection between the dental implant
and the overlying soft-tissues for the final connection to a tooth
replacement prosthesis visible inside the mouth.
[0251] The implant 30 and screw 50 are made of surgical steel or
other metals such as titanium/titanium alloy. The post is made of
steel, ceramic of other durable material such as gold alloy, e.g.
AuPdAg (gold-palladium-silver). The shell is zirconium oxide
ceramic or other suitable material as listed above. The luting
compound is, for example resin or resin-ionomer. The tooth-form
temporary 70 is made of material such as polymethyl methacrylate
(PMMA), polyetheretherketone (PEEK), lithium disilicate, or
zirconium dioxide.
[0252] Drilling Guide Feature:
[0253] A further and more general object of the invention is to
provide a dental implant method and arrangement that uses a hollow
shell 10 as shown in FIGS. 3-10, 13 and 14 with visual orientation
guide markings 402 or physical orientation guide structures 502 and
602 to inform the operator of the spatial relationship of the
residual soft-tissue gingival socket to the use of bone drilling
burs and instruments. Thus the hollow shell 10 with peaks and
valleys provides a spatial relationship during bone drilling and
implant insertion phase after tooth extraction and during the
immediate dental implant placement to the underlying bone. The
shell is imbued with distinct visual and radiographic guide markers
upon the hollow shell as illustrated in FIGS. 3 through 10.
[0254] These markings may be surface marking of a design of visual
markings 402 on the inner surface of the 10 as shown in FIG. 3 or
at 404 on the outer surface as shown in FIG. 5, or can be on the
inner and/or outer surface of the hollow shell as shown at FIG. 7
to 10. The visual guide markings provide an x-axis and y-axis of
the horizontal plan as depicted in FIGS. 4 and 13 at marking posts
502X and 502Y and include curved marking arcs 502A, and in FIGS. 6
and 14 at marker posts 602Z that extend from the shell 10 in
generally the Z direction that is substantially parallel to the
implant axis 32 (FIG. 1) and with curved marker arcs 602A to help
further visually guide the drilling direction of a dental drilling
bur 804 in FIGS. 13 and 14, of a dental drill or handpiece 802.
[0255] The intersection point of these axes x, y and z provides a
visual point at which the bone drill bur 804 can be positioned as
best illustrated in FIGS. 13 and 14. The vertical long axis z of
the visual guiding marking on the hollow shell, for example 402 in
FIG. 8, provides the long axis of the vertical plan, providing the
z-axis. The intersection of the three planes of space thereby
providing a visual point of position of the bone drilling bur as
well as the path that the drill bit should take as it drills into
the underlying bone, depicted in FIGS. 13 and 14.
[0256] The physical markings may be visual guide markings such as
laser etching, decals, colored markings and/or physical structural
guides on the surface such as indents, detents, internal or
external tabs. The preferred embodiment may be a combination of
visual guide markings and/or winged-vertical-posts 502 and 602
providing a means of displaying spatial orientation of the hollow
shell and its relationship to the residual soft-tissue gingival
socket and underlying alveolar as in FIGS. 13 and 14. The preferred
embodiment of these visual markings would be four separate vertical
bars 402 or 404 that would are used to provide directional
instruction and/or information to the position of the underlying
bone. The orientation markings provide a visual instruction to the
direction that should be used during drilling and insertion.
[0257] In another embodiment the outer and/or vertical inner
markings on the surface of the hollow shell would correspond to the
peaks and valleys of the design and mimic the shape and contour of
the residual soft-tissue socket allowing the hollow shell to be
provide an orientation to insertion of drilling instruments within
the natural occurring peaks and valleys of the residual soft-tissue
socket opening of the extracted tooth. These visual and/or physical
markings simplify the insertion during the drilling and implant
bone preparation phase of treatment by providing the horizontal
x-axis, y-axis and z-axis to the residual soft-tissue gingival
socket. The drilling bur is kept within the circumference of the
hollow shell thereby relating the positioning the bone drill within
the residual soft tissue socket in the horizontal plane and
providing the vertical path that is to be taken when inserting the
bone drill bur, all references from the residual soft-tissue
socket. This technique would ensure that the final access hole to
the implant prosthesis would be within the residual soft tissue
socket circumference and angulated to exit within the confines of
socket as well. The hollow shell provides prosthetic and surgical
guide attributes and could be distinct and separate from the
previous hollow shell with biologic surface characteristics
previously described or it may be in combination with the a
biologic surface as described herein. A variety of hollow shells
are available with different lengths, widths, shapes and diameters
in three dimensions of space.
[0258] In another embodiment the x, y and z-axis's can be visually
provided via the use of winged-posts or post with arc pieces 502A
and 60A as depicted in FIGS. 4 and 6. The winged-posts 502A and
602A provide the horizontal intersection of the x-axis and y-axis
in the horizontal plane. The intersection of these two points
provides a visual point at which the bone drilling bur can be
inserted. The vertical arm or post 502X and 602Z of the winged-post
provides the z-axis, i.e. vertical axis, to the path of insertion
of the bone drilling bur. The wings 502A and 602A at the upper
limit of the posts 502 and 602 provide enhanced visual referencing
of the vertical winged-posts depicted in FIGS. 4 and 6.
[0259] The hollow shell 10 with visual guide markings are
positioned within the soft-tissue socket 108 as previously
described and shown in FIGS. 3 to 10, 13 and 14. The bone drilling
bur 804 and instruments make no physical contact with the hollow
shell structure 10, therefore the bone drilling bur is kept
independent of the hollow shell guide unlike previous descriptions
of bone drilling guides that require the bone drill to make
physical contact during use. The hollow shell provides a visual
guide and axis orientation without the need of the bone drilling
bur to be in direct contact with the surface of the guide.
[0260] Yet, another distinction over the prior art is the ability
of the hollow shell's ability to stop bleeding during the drilling
and implant insertion phase of the procedure. As it is commonly
known in the field of dentistry that after a tooth is extracted
bleeding occurs from the "fresh" extraction site. The majority of
the bleeding is known to come from the exposed soft-tissue. The
hollow shell comes into direct contact with the residual socket and
exposed soft tissues in which it is difficult to apply direct
pressure towards. The hollow shell makes intimate and direct
contact to the fresh soft tissue extraction site thus applying
physical contact to the exposed bleeding surface of the soft tissue
socket, the physical contact of the outer surface to the internal
socket of the soft tissue stops the bleeding rapidly. The hollow
shell thereby provides improved visualization to the extraction
site at a crucial time of bone preparation. The hollow shell via
direct contact to the bleeding soft tissue socket allows superior
visualization to the extraction site. This greatly aids in the
ability of the clinician to drill the bone as it provides a
bloodless site during bone drilling. Another distinct advantage of
a hollow shell surgical guide is the ability to prevent the soft
tissue socket from collapsing after tooth removal. It is known in
the field of dentistry that after tooth removal the soft tissue
will immediately begin to collapse into the unsupported extraction
socket. As the soft tissue collapses into the socket bone drilling
preparation is greatly compromised as visualization and obstruction
by the soft tissues becomes a complicating factor during the
immediate implant placement at the time of tooth extraction. The
placement of a hollow shell surgical guide prevents the soft tissue
from collapsing and maintains a clear and open visual field for the
immediate implant placement. Hence, the surgical guide prevents
soft tissue collapse and access to the implant surgical site and it
provides the ability to stop bleeding during the drilling and
implant insertion phase of treatment, these are additional distinct
advantages over the prior art.
[0261] It is also anticipated that this hollow shell with visual
guide markings and orientation winged-posts and the like (i.e.,
surgical guide) be also designed and used as a radiographic guide
during the diagnostic phase which is present immediately after
tooth removal (and prior to immediate implant is placement). This
application of the hollow shell with visual guide markings is
designed to index the residual soft tissue socket perimeter and the
path to be taken in the y-axis, to the underlying bone when viewed
on an x-ray or other means of radiographic, digital Scanning,
photographic or alternative means of physical recordings or
records. In which case the hollow shell could be fabricated from a
variety of materials that is radiolucent, such as acrylic,
polymers, plastic materials, PEEK material, to allow the x-ray beam
to readily pass through such material in combination with
orientation markings designed of radio-opaque materials such as
gutta-percha, barium liquid, metals paints, etc. as the visual or
physical orientation markings upon the surface of the hollow shell.
The hollow shell to be placed within the soft-tissue residual
socket after a tooth has been removed. A radiograph is then taken
prior to drilling of the bone at the time of surgery. The
radiographic markings on the surface of the hollow shell would
provide directional instruction and insertion orientation to the
bone that is below the soft tissue socket. The operator could then
reference the bone that is below the soft tissue socket by the
visual markings on the hollow shell at the time of surgery. This
simplifies the use of bone drilling instruments in the
determination of proper directions and insertion. The prior art
radiographic guides rely upon position bone and its relative
position to adjacent teeth to stabilize a radiographic guide. The
hollow shell with orientation markings relies solely on the soft
tissue residual socket for stabilization of the guide. The
structure of the hollow shells perimeter and ability to replicate
the peaks and valleys of the soft tissue establishes an intimate
physical fit of the hollow shell to the soft tissue socket. This
hollow shell thereby provides a reliable alternative to other
radiographic guides described in the prior art. The invention
herein described relies solely on the residual soft tissue socket
remaining after the extraction of a tooth.
[0262] Nowhere in the prior art does a surgical guide or
radiographic guide with orientation markings rely solely upon the
position of the remaining soft tissue socket as a means to provide
instruction or guidance in the direction of drilling and insertion
of the immediate dental implant.
[0263] The hollow shell with orientation markings provide the
relationship between the residual soft-tissue gingival socket
relative to the underlying spatial position of the extraction
socket and is recorded or noted using a spatial referencing system
in the x, y and z, i.e. horizontal, vertical and transverse planes.
The preferred embodiment would be in the vertical direction but off
axis and a combination of horizontal, vertical and transverse axis
is anticipated. The spatial markings provide the relation of the
bone to the residual soft-tissue gingival socket and provide
important information that is used during bone drilling and implant
insertion. After the bone is drilled and the implant is inserted
the hollow shell with orientation markings is removed. It is also
conceivable that this same hollow shell with orientation markings
could be used to fabricate a temporary abutment. The orientation
guide hollow shell could be fabricated from a variety of materials
but not limited to metals, ceramics, polymers, acrylic, zirconia,
composites and other materials typically used.
[0264] In more detail and with reference to FIGS. 13 and 14, a soft
tissue preserving and drill guide dental implant method of the
invention is used immediately after a tooth has been extracted to
leave a soft tissue socket 108 having an anatomical shape, and a
bone socket 106, the implant hole 810 to be drilled using a drill
802 and bur 804 for receiving an implant 30 (see FIG. 1) at an
extraction site. The method includes first providing the hollow
dental implant shell 10 having an outer surface conforming
substantially to the shape of the soft tissue socket 108 that is
left immediately after the tooth extraction from the bone socket,
the shell having a plurality of markings 402 and/or 404 and/or 502
and/or 602 that are more opaque to x-rays than the material of the
shell so that the markings are clearly visible in an x-ray image of
the extraction site.
[0265] The dental implant shell 10 is then inserted into the soft
tissue socket 108 that was left immediately after tooth extraction
from a bone socket. At least one x-ray image of the extraction site
is then taken with the shell in the soft tissue socket and the bone
socket near the shell. Using the x-ray so the practitioner can see
the relationship of the and shell and soft tissue socket to the
bone socket, and visual inspection of the actual shell in the soft
tissue socket, the drilling of a hole 810 for receiving a dental
implant in the area of the bone socket is guided. The dental
implant is then inserted into the drilled hole 810 and, according
to the invention this is without mechanically connecting the dental
implant 30 to the shell 10 so that the shell stays seated in the
soft tissue socket without disturbing the shape and anatomy of the
soft tissue socket, while the dental implant 30 is seated in the
hole 810 at its best orientation.
[0266] As noted above, the markings may be inner surface marking
402 on an inner surface of the shell, and/or outer surface markings
404 on the outer surface of the shell, and/or a post 602 extending
from the shell, and/or a post 502 extending toward in inner hollow
volume of the shell.
[0267] The markings are arranged so that a first pair of markings,
for example markings 402, 402 in FIG. 8, are on opposite sides of
the shell 10 on an x axis of the shell extending along an arch of a
jaw containing the bone socket, a second pair of markings 404, 404
for example in FIG. 9, are on opposite sides of the shell on a y
axis of the shell extending lingually and buccally, and at least
part of each marking, for example marking posts 602 in FIG. 6,
extend on a z axis that is substantially parallel to at least one
of a soft tissue axis 12 or the bone socket axis or implant axis
32.
[0268] A further and more general object of the invention is to
provide a hollow shell with an extended labial (buccal) surface
shown in FIG. 7 to 10. The hollow shell with labial surface would
provide an outer shape similar to the curvature of the natural
tooth. This hollow shell with veneer would provide a dual purpose
of providing additional information and aid in the orientation of
the drilling instruments. A second advantage to the hollow shell
with labial tooth surface is to provide an easier means in the
fabrication of a temporary tooth and abutment for the immediate
implant placement after tooth extraction. In the preferred
embodiment the hollow shell with labial surface and incisal edge
404 in FIG. 7 could have internal and/or external orientation
markings 404. In another embodiment the hollow shell with labial
surface and incisal edge would not have internal or external visual
markings and would rely upon the physically design solely for
orientation and directional information. The hollow shell would be
composed of a variety of dental materials including but not limited
to metal, acrylic, zirconia, polymers, plastics, peek materials and
the like.
[0269] The hollow shell with labial tooth surface aids in
orientation of bone drilling instruments by providing visual
information as to the proper position of the incisal edge of a
tooth that is being replaced. The hollow shell with labial tooth
surface would insert within the soft tissue extraction socket
providing an additional means to the visual orientation of the bone
drilling instruments. The labial surface of the hollow shell is
extended to the incisal edge thus providing boundaries during bone
drilling. It is commonly accepted in the art of implant surgical
placement that the long axis of the implant needs to be positioned
lingual to the incisal edge of teeth. A hollow shell with a labial
surface extending to the incisal edge would provide a structure and
means to enable a dental surgeon to direct the bone drilling in the
proper orientation described. The hollow shell with labial surface
extending to the incisal edge prevents the surgeon from positioning
the bur beyond the incisal edge in a buccal direction. This ensures
that the immediate dental implants will be orientated in a
favorable position by providing a visual aide to the clinician at
the time of surgery.
[0270] In invention thus sues a hollow shell with orientation
markings as a surgical guide and a radiographic guide. The hollow
shell with labial surface and incisal edge or these above two
devices can be combined (two distinct devices).
[0271] While specific embodiments of the invention have been shown
and described in detail to illustrate the application of the
principles of the invention, it will be understood that the
invention may be embodied otherwise without departing from such
principles.
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