U.S. patent application number 15/613604 was filed with the patent office on 2017-09-28 for soft-tissue preservation arrangement and method.
The applicant listed for this patent is BIOMET 3I, LLC. Invention is credited to Stephen S. Porter, Michael J. Traylor.
Application Number | 20170273761 15/613604 |
Document ID | / |
Family ID | 53525122 |
Filed Date | 2017-09-28 |
United States Patent
Application |
20170273761 |
Kind Code |
A1 |
Porter; Stephen S. ; et
al. |
September 28, 2017 |
SOFT-TISSUE PRESERVATION ARRANGEMENT AND METHOD
Abstract
According to one aspect of the present invention, a soft tissue
preservation arrangement includes a hollow shell defining an
interior volume extending from a proximal opening to a distal
opening. The proximal opening is defined by a first perimeter that
is smaller than a second perimeter defining the distal opening such
that the shell tapers outwardly from the first perimeter to the
second perimeter. The second perimeter is asymmetrically scalloped.
The hollow shell either (1) is transparent or semi-transparent or
(2) has a color configured to correspond to a color of a gingival
tissue or a tooth.
Inventors: |
Porter; Stephen S.; (West
Palm Beach, FL) ; Traylor; Michael J.; (Palm City,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BIOMET 3I, LLC |
Palm Beach Gardens |
FL |
US |
|
|
Family ID: |
53525122 |
Appl. No.: |
15/613604 |
Filed: |
June 5, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14466505 |
Aug 22, 2014 |
9700390 |
|
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15613604 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61C 8/0036 20130101;
A61C 8/0077 20130101; A61C 8/0001 20130101; A61C 8/0098 20130101;
A61C 8/008 20130101 |
International
Class: |
A61C 8/00 20060101
A61C008/00 |
Claims
1. A soft tissue preservation arrangement comprising: a hollow
shell defining an interior volume extending from a proximal opening
to a distal opening, the proximal opening being defined by a first
perimeter that is smaller than a second perimeter defining the
distal opening such that the shell tapers outwardly from the first
perimeter to the second perimeter, the second perimeter being
asymmetrically scalloped, the hollow shell is one of group selected
from transparent, semi-transparent, or having a color configured to
correspond to a color of a gingival tissue or a tooth.
2. The arrangement of claim 1, wherein the hollow shell is
transparent.
3. The arrangement of claim 1, wherein the hollow shell is
semi-transparent
4. The arrangement of claim 1, further comprising a luting compound
for coupling the hollow shell to a post positioned in the interior
volume, the luting compound having a color configured to correspond
to a color of a gingival tissue at an implantation site, the luting
compound being visible through a surface of the shell.
5. The arrangement of claim 4, wherein the luting compound is a
pink color.
6. The arrangement of claim 4, wherein the luting compound is a
brown color or a blue color.
7. The arrangement of claim 1, further comprising a luting compound
for coupling the hollow shell to a post positioned in the interior
volume, the luting compound having a color configured to correspond
to a color of a tooth adjacent to an implantation site, the luting
compound being visible through a surface of the shell.
8. The arrangement of claim 1, wherein the shell has a pink
color.
9. The arrangement of claim 1, further comprising: a post
configured to be coupled to an implant; and a plurality of spokes
adjustably coupling an outer surface of the post to an inner
surface of the shell, the plurality of spokes being configured to
allow the shell to be adjustably moved relative to the post.
10. The arrangement of claim 1, wherein the shell is mechanically
decoupled from a post prior to a luting compound being applied to
the shell and the post.
11. The arrangement of claim 1, wherein the asymmetrically
scalloped shape of the second perimeter includes a distal peak, a
mesial peak opposite the distal peak, a lingual valley between the
distal peak and the mesial peak, and a facial valley opposite the
lingual valley
12. A dental restoration method comprising: extracting a tooth to
form a bone socket and a soft tissue socket; inserting an implant
into the bone socket; coupling a post to the implant; selecting a
shell from a plurality of shells based on an analysis of the soft
tissue socket, the shell defining an interior volume extending from
a proximal opening to a distal opening, the proximal opening being
defined by a first perimeter that is smaller than a second
perimeter defining the distal opening such that the shell tapers
outwardly from the first perimeter to the second perimeter, the
second perimeter being asymmetrically scalloped, the hollow shell
being transparent or semi-transparent; placing the shell into the
soft tissue socket such that the post extends in the interior
volume of the shell, the shell being independently movable relative
to the post; and applying a luting compound to an interior space
between an outer surface of the post and an inner surface of the
shell so as to fixedly couple the shell to the post, the luting
compound having a color corresponding to a color of the soft tissue
socket or the tooth, the luting compound being visible through the
shell.
13. The method of claim 12, further comprising selecting the luting
compound from a plurality of premade luting compounds having
different colors.
14. The method of claim 12, further comprising preparing the luting
compound based on an analysis of the color of the soft tissue
socket or the tooth.
15. The method of claim 14, wherein the analysis includes a
comparing the soft tissue socket or the tooth with a plurality of
shade guides.
16. The method of claim 12, wherein the shell is adjustably coupled
to the post prior to the post being coupled to the implant and the
shell being placed in the soft tissue socket.
17. The method of claim 12, wherein the shell is mechanically
decoupled from the post prior to the luting compound being
applied.
18. A soft tissue preservation arrangement comprising: a hollow
shell defining an interior volume extending from a proximal opening
to a distal opening, the proximal opening being defined by a first
perimeter that is smaller than a second perimeter defining the
distal opening such that the shell tapers outwardly from the first
perimeter to the second perimeter, the second perimeter being
asymmetrically scalloped; a post configured to be coupled to a
dental implant; and a plurality of spokes adjustably coupling the
post to the hollow shell, the plurality of spokes being configured
to allow the shell to be adjustably moved relative to the post.
19. The arrangement of claim 18, wherein the plurality of spokes
are configured to allow the shell to be moved in an x-dimension, a
y-dimension, and a z-dimension.
20. The arrangement of claim 19, wherein the plurality of spokes
are further configured to allow the shell to be rotated about the
x-dimension, the y-dimension, and the z-dimension.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to the field of
dental implants and, in particular, to a new and useful soft-tissue
preservation arrangement and method.
BACKGROUND OF THE INVENTION
[0002] 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. This portion of the
tooth that is connected to the bone can be defined 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 the crest of bone and
includes 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. This
tissue-zone connection (i.e. soft-tissue to tooth attachment) is
composed of gingival fibers that insert into the superior aspect of
the root surface; specifically, hemidesmosmal cell attachment to
the root and crown forming a biological adhesion of the sulcular
epithelium (gingival tissues) to the surface of a tooth.
[0003] The 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. 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.
[0004] 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. 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 alteration 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.
[0005] 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.
[0006] 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. 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.
[0007] As will be explained more fully in the following, the method
and arrangement of the present invention provide an effective means
to preserve the esthetic and anatomic architecture of the
tissue-zone after tooth removal and the immediate placement of a
dental implant. In addition, the present invention simultaneously
and effectively re-establishes the biologic-seal after tooth
removal and immediate implant placement.
[0008] Immediate implant placement of a root-form dental implant
has been shown to effectively osseointegrate. 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 2-3 days after the immediate implant placement.
SUMMARY OF THE INVENTION
[0009] According to one aspect of the present invention, a soft
tissue preservation arrangement includes a hollow shell defining an
interior volume extending from a proximal opening to a distal
opening. The proximal opening is defined by a first perimeter that
is smaller than a second perimeter defining the distal opening such
that the shell tapers outwardly from the first perimeter to the
second perimeter. The second perimeter is asymmetrically scalloped.
The hollow shell either (1) is transparent or semi-transparent or
(2) has a color configured to correspond to a color of a gingival
tissue or a tooth.
[0010] According to another aspect of the invention, a dental
restoration method includes extracting a tooth to form a bone
socket and a soft tissue socket, inserting an implant into the bone
socket, and coupling a post to the implant. The method also
includes selecting a shell from a plurality of shells based on an
analysis of the soft tissue socket. The shell defines an interior
volume extending from a proximal opening to a distal opening. The
proximal opening is defined by a first perimeter that is smaller
than a second perimeter defining the distal opening such that the
shell tapers outwardly from the first perimeter to the second
perimeter. The second perimeter is asymmetrically scalloped. The
hollow shell is transparent or semi-transparent. The method further
includes placing the shell into the soft tissue socket such that
the post extends in the interior volume of the shell. The shell is
independently movable relative to the post. The method still
further includes applying a luting compound to an interior space
between an outer surface of the post and an inner surface of the
shell so as to fixedly couple the shell to the post. The luting
compound has a color corresponding to a color of the soft tissue
socket or the tooth. The luting, compound is visible through the
shell.
[0011] According to yet another aspect of the invention, a soft
tissue preservation arrangement includes a hollow shell defining an
interior volume extending from a proximal opening to a distal
opening. The proximal opening is defined by a first perimeter that
is smaller than a second perimeter defining the distal opening such
that the shell tapers outwardly from the first perimeter to the
second perimeter. The second perimeter is asymmetrically scalloped.
The arrangement also includes a post configured to be coupled to a
dental implant, and a plurality of spokes adjustably coupling the
post to the hollow shell. The plurality of spokes are configured to
allow the shell to be adjustably moved relative to the post.
[0012] Additional aspects of the invention will be apparent to
those of ordinary skill in the art in view of the detailed
description of various embodiments, which is made with reference to
the drawings, a brief description of which is provided below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is an exploded view of a soft-tissue preservation,
dental implant arrangement according to some aspects of the present
invention.
[0014] FIG. 2 is a perspective view of a shell according to some
aspects of the present invention.
[0015] FIG. 3 is a perspective view of a shell according to
additional aspects of the present invention.
[0016] FIG. 4 is a perspective view of a shell according to further
aspects of the present invention.
[0017] FIG. 5 is a perspective view of the shell shown in FIG.
1.
[0018] FIG. 6 is a sectional view of the soft-tissue preservation,
dental implant arrangement of FIG. 1 after a luting compound has
been applied.
[0019] FIG. 7 is a composite, side-by-side, rear (lingual) and
front (facial) perspective view of an immediate tooth-form
temporary according to aspects of the present invention.
[0020] FIG. 8 is a composite view of parts of a
soft-tissue-preservation abutment in a sequence showing an assembly
of the parts of the abutment according to some aspects of the
present invention.
[0021] FIG. 9 is a flowchart for a process of employing a shell to
form a soft-tissue preservation, dental implant arrangement
according to some aspects of the present invention.
[0022] FIG. 10A is a side view of a post and a shell according to
further aspects of the present invention.
[0023] FIG. 10B is a cross sectional view of the post and shell of
FIG. 10A.
[0024] FIG. 10C is a bottom view of the post and shell of FIG.
10A.
[0025] FIG. 10D is a bottom perspective view of the post and shell
of FIG. 10A.
[0026] FIG. 10E is top perspective view of the post and shell of
FIG. 10A.
[0027] FIG. 11A is a perspective view of a shell and a post
connected by a first type of spoke according to additional aspects
of the present invention.
[0028] FIG. 11B is a bottom view of the shell and the post
connected by the first type of spoke from FIG. 11A
[0029] FIG. 12A is a perspective view of a shell and a post
connected by a second type of spoke according to additional aspects
of the present invention.
[0030] FIG. 12B is a bottom view of the shell and the post
connected by the second type of spoke from FIG. 12A.
[0031] FIG. 13A is a perspective view of a shell and a post
connected by a third type of spoke according to additional aspects
of the present invention.
[0032] FIG. 13B is a bottom view of the shell and the post
connected by the third type of spoke from FIG. 13A.
[0033] FIG. 14A is a perspective view of a shell and a post
connected by a fourth type of spoke according to additional aspects
of the present invention.
[0034] FIG. 14B is a bottom view of the shell and the post
connected by the fourth type of spoke from FIG. 14A.
[0035] While the invention is susceptible to various modifications
and alternative forms, specific embodiments have been shown by way
of example in the drawings and will be described in detail herein.
It should be understood, however, that the invention is not
intended to be limited to the particular forms disclosed. Rather,
the invention is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the invention
as defined by the appended claims.
DETAILED DESCRIPTION
[0036] While this invention is susceptible of embodiment in many
different forms, there is shown in the drawings and will herein be
described in detail preferred embodiments of the invention with the
understanding that the present disclosure is to be considered as an
exemplification of the principles of the invention and is not
intended to limit the broad aspect of the invention to the
embodiments illustrated. For purposes of the present detailed
description, the singular includes the plural and vice versa
(unless specifically disclaimed); the words "and" and "or" shall be
both conjunctive and disjunctive; the word "all" means "any and
all"; the word "any" means "any and all"; and the word "including"
means "including without limitation."
[0037] FIG. 1 illustrates a soft-tissue preservation, dental
implant arrangement 2 according to sonic aspects of the present
invention. The arrangement 2 includes a hollow shell 10 with an
interior volume 4 and a shell axis 12. The shell 10 has a lower
first perimeter 16 adapted for placement toward the bone socket 102
(FIG. 6) of a lower mandibular, tooth. The first or inner perimeter
16 may be an upper perimeter if the shell 10 is to be used for
replacing of an extracted upper or maxillary tooth so that terms
like "upper" and "lower" as used herein are only relative terms and
do not convey an absolute position or limitation.
[0038] The shell 10 also has a second or outer perimeter 18 adapted
for placement adjacent an outer surface of the gingival tissue 108,
around the soft-tissue socket 100. The first perimeter 16 is
smaller than the second perimeter 18 so that the shell 10 tapers
outwardly from the first perimeter 16 to the second perimeter 18 to
anatomically mimic the shape of the soft-tissue socket 100 that
remains immediately after a tooth has been extracted, and before
the soft-tissue socket 100 starts to shrink or shift from the
natural size, shape and position it had around the patient's
natural tooth before extraction.
[0039] To further anatomically mimic the shape of the soft-tissue
socket 100, the second perimeter 18 is also asymmetrically
scalloped with a distal peak 20, a mesial peak 22 opposite the
distal peak 20, a lingual valley 24 between the peaks 20, 22, and a
facial valley 26 between the peaks 20, 22 opposite the lingual
valley 24. The shapes, sizes, locations and heights of the peaks
20, 22 and valleys 24, 26 are selected to mimic different tooth
types (e.g., maxillary or mandibular, central or lateral incisors,
canines, premolars and molars) as described in greater detail
below. The shell 10 is also sized for closely engaging against the
soft-tissue socket 100 and mitigating gaps between the soft-tissue
socket 100 and the shell 10. This sizing and shaping can be
achieved by providing the practitioner with a set (i.e., a kit) of
a plurality of shells 10 having different shapes, sizes and types
so that a shell 10 can be selected based on patient-specific
conditions to closely fit and engage the soft-tissue socket 100
without gaps and, thus, form a biological or biologic-seal
inhibiting ingress of contaminants to the soft-tissue socket 100
and the underlying bone socket 102.
[0040] The arrangement 2 also includes a dental implant 30 having
an implant axis 32. The dental implant 30 is configured for
placement in the bone socket 102 immediately after tooth
extraction. It should be understood that, prior to placement of the
dental implant 30, the bone socket 102 can be cleared and dressed,
for example, by removing debris and drilling a bore in the bone
socket 102. As non-limiting examples, the implant 30 can be made of
surgical steel or other metals such as titanium/titanium alloy.
[0041] The arrangement 2 further includes a temporary post 40
configured to be coupled to the dental implant 30 in coaxial
alignment. For example, the temporary post 40 can be coupled to the
dental implant 30 by a screw 50 that is inserted into a central
bore 46 in the post 40 and screwed into a treaded bore in the
implant 30 such that a head 52 of the screw 50 can engage an
annular step in the post 40. As non-limiting examples, the post 40
can be made of steel (e.g., stainless steel), titanium,
polyether-ether-ketone (PEEK), ceramic or other durable material
such as gold alloy, e.g. AuPdAg (gold-palladium-silver).
[0042] As will be described in detail below, the shell 10 is placed
in the soft-tissue socket 100 with a freedom of motion in the x-,
y- and z-directions and with freedom of rotation about all three
axes. According to some aspects of the present disclosure, this
freedom of motion is achieved by mechanically de-coupling the shell
10 from the implant 30 (which is rigidly fixed in the bone socket
102 at its own angle and depth) or the post 40. According to
alternative aspects of the present disclosure described below with
respect to FIGS. 10A-14B, the shell 10 is adjustably coupled to the
post 40 by a plurality of spokes 342 that allow for independent
positioning and orientation of the shell 10 relative to the post
40. In either case, the post 40 extends from the implant 30 through
the interior volume 4 of the shell 10 when the implant 30 is placed
in the bone socket 102, the shell 10 is placed in the soft-tissue
socket 100, and the post 40 is coupled to the implant 30. Also, in
either case, the position and orientation of the shell 10 can be
adjusted with respect to the implant 30 such that the positions and
orientations of the shell 10 and the implant 30 (and, thus, the
post 40) can be independently determined based on the soft-tissue
socket 100 and the bone socket 102, respectively, when the implant
30 is placed in the bone socket 102, the shell 10 is placed in the
soft-tissue socket 100, and the post 40 is coupled to the implant
30. In other words, the shell 10 and the implant 30 can be
independently positioned and oriented in the soft-tissue socket 100
and the bone socket 102, respectively, without requiring alignment
of the shell axis 12 and the implant axis 32.
[0043] The arrangement 2 still further includes a luting compound
60 (shown in FIGS. 6 and 8) configured to fixedly couple the shell
10 to the post 40 once the shell 10 and the implant 30 have been
placed in the soft-tissue socket 100 and the bone socket 102,
respectively. The luting compound 60 can be initially fluid such
that the luting compound 60 can be filled into an interior space
between the shell 10 and the temporary post 40 and allowed to set
solid. In the illustrated example of FIGS. 1-6 and 8, only then is
the shell 10 fixed to the post 40 and the implant 30, with no other
previous connection between the shell 10 and the implant 30 so that
an outer surface 14 of the shell 10 engages against the soft-tissue
socket 100 without gaps and without requiring any alignment between
the shell axis 12 and the implant axes 32. The luting of the shell
10 to the post 40 forms a temporary soft-tissue-preservation
abutment, which can be removably coupled to the implant 30 (e.g.,
via the screw 50).
[0044] The application of the luting compound 60 also seals the
bone socket 102 in the jaw bone 106, which, in the case of FIG. 6,
is the maxilla that is shown to have other teeth 104 on opposite
sides of the extracted tooth socket 102. An inner surface 15 of
shell 10 can be configured to facilitate adherence of the luting
compound 60 to the inner surface 15. According to some aspects, to
improve such adherence, the inner surface 15 can be treated, e.g.
by roughening its texture.
[0045] As described above, a kit including a plurality of shells 10
can be provided to facilitate the selection of a shell 10 based on
one or more patient specific conditions (e.g., a type of tooth to
be replaced, a size of the soft-tissue socket 100, a shape of the
soft-tissue socket 100, etc.) to closely fit and engage the
soft-tissue socket 100. By selecting and placing an appropriate
shell 10 from the kit into a patient's soft-tissue socket 100, the
soft-tissue gingival architecture can be preserved, a biological or
biologic-seal can be formed, and/or bone regenerative materials can
be retained.
[0046] The plurality of shells 10 that make up the kit can have a
plurality of different dimensions and/or shapes. According to some
aspects of the present disclosure, the shells 10 in the kit can be
configured to replace different, specific types of teeth. For
example, in FIGS. 1 and 5, the lingual valley 24 is lower than the
facial valley 26 for mimicking maxillary and mandibular incisors.
For mimicking maxillary and mandibular canines, the lingual valley
24 and the facial valley 26 can be of substantially equal height as
illustrated, for example, in FIG. 2. For premolars and molars, the
opposite of incisors is true so that, as shown in FIG. 3, the
lingual valley 24 can be higher than the facial valley 26 and
mesial and distal peaks 20 and 22 are not as highly scalloped as in
incisors. Also, for some tooth types, the distal and mesial peaks
20 and 22, as shown in FIG. 4, are not in a common plane 23 with
the plane 25 extending through the shell axis 12. The asymmetry can
be also selected to more closely mimic the true shape and size of a
soft-tissue socket 100 before it starts to deteriorate. It should
be understood that these shapes are merely examples and not
absolute rules since there can always be exceptions and variations
to the rules as dental anatomy varies and may sometimes reside
outside the norms. The kit of shells 10 in various sizes, types and
shapes provided to the practitioner can accommodate these
variations by allowing the practitioner to select a shell 10 for a
different tooth replacement type.
[0047] According to a non-limiting implementation, the plurality of
shells 10 provided in the kit can include a series of different
tissue-zone heights ranging from approximately 2 mm to
approximately 5 mm and a plurality of root form configurations with
a plurality of horizontal widths. To further illustrate, the
following are non-limiting examples of shapes, sizes, and/or
dimensions for a plurality shells 10 from which a kit may be
comprised:
[0048] Maxillary Right Central Incisor: Height 2 mm, Height 3 mm,
thru 5 mm. Diameter, Small, Medium and Large. An irregular superior
surface is provided to conform to the soft-tissue gingival
architecture. The interproximal points can be longer in dimensions
then the labial and lingual surfaces. The inner shell allows for
the eccentric position of the shell 10 over the center axis of the
implant 30 held within the bone 102.
[0049] Maxillary Right Lateral Central Incisor: Height 2 mm, Height
3 mm, thru 5 mm. Diameter, Small, Medium and Large. An irregular
superior surface is provided to conform to the soft-tissue gingival
architecture. The interproximal points can be longer in dimensions
then the labial and lingual surfaces. The inner shell allows for
the eccentric position of the shell 10 over the center axis of the
implant 30 held within the bone 102.
[0050] Maxillary Right Canine: Height 2 mm, Height 3 mm, thru 5 mm.
Diameter, Small, Medium and Large. An irregular superior surface is
provided to conform to the soft-tissue gingival architecture. The
interproximal points can be longer in dimensions then the labial
and lingual surfaces. The inner shell allows for the eccentric
position of the shell 10 over the center axis of the implant 30
held within the bone 102.
[0051] Maxillary Left Central Incisor: Height 2 mm, Height 3 mm,
thru 5 mm. Diameter, Small, Medium and Large. An irregular superior
surface is provided to conform to the soft-tissue gingival
architecture. The interproximal points can be longer in dimensions
then the labial and lingual surfaces. The inner shell allows for
the eccentric position of the shell 10 over the center axis of the
implant 30 held within the bone 102.
[0052] Maxillary Left Lateral Central Incisor: Height 2 mm, Height
3 mm, thru 5 mm. Diameter, Small, Medium and Large. An irregular
superior surface is provided to conform to the soft-tissue gingival
architecture. The interproximal points can be longer in dimensions
then the labial and lingual surfaces. The inner shell allows for
the eccentric position of the shell 10 over the center axis of the
implant 30 held within the bone 102.
[0053] Maxillary Left Canine: Height 2 mm, Height 3 mm, thru 5 mm.
Diameter, Small, Medium and Large. An irregular superior surface is
provided to conform to the soft-tissue gingival architecture. The
interproximal points can be longer in dimensions then the labial
and lingual surfaces. The inner shell allows for the eccentric
position of the shell 10 over the center axis of the implant 30
held within the bone 102.
[0054] It should be understood that the kit can include any
combination of two or more of the above example shells 10, or other
shells 10 having different shapes, sizes, and/or dimensions than
the examples described above. According to additional and/or
alternative aspects of the present disclosure, the kit can also
include one or more luting compounds 60, plugs 80, and/or tooth
form temporaries 70 described in greater detail below. It is
contemplated that the dimensions and shapes of the shells 10
provided in the kit can be based on an analysis (e.g., a
statistical analysis) of a plurality of soft-tissue sockets 100
remaining after tooth removal. Additionally, it should be
understood that, according to additional and/or alternative aspects
of the present disclosure, the shell 10 can be custom made shell 10
for a particular patient.
[0055] One of the functions of the shell 10 is to preserve the
esthetics of the gingival tissue. However, it has been discovered
that when the shell 10 is installed, a portion of the shell 10 may
remain visible above the gingival tissue under some circumstances.
The color discrepancy between the shell 10 and the adjacent teeth,
gingival tissue, and/or dental prosthesis (e.g., an attached
tooth-form such as the type described and illustrated for FIG. 7)
negatively impacts the esthetics. According to some aspects of the
present invention, one approach for addressing such problems is to
make the shell 10 from a material having a color that mimics (i.e.,
generally corresponds to) the color of the adjacent teeth, gingival
tissue, and/or dental prosthesis. For example, the shell 10 can be
configured to mimic the color of an adjacent tooth, gingival
tissue, or dental prosthesis by selecting a material for the shell
10 based on techniques employed in cosmetic dentistry for final
prosthesis color matching. As non-limiting examples, the shell 10
can be configured to have a color for approximating the color of a
patient's gingival tissue (e.g., pale pink, coral pink, light
brown, dark brown, etc.) using PEEK, titanium (e.g., anodized
titanium), Polyoxymethylene (POM) (e.g., DELRIN), 3D printable
materials, and/or the like. While this approach may be effective,
it can be challenging or impractical to manufacture such shells 10
on a commercial scale due to the wide variety of colors that may be
required to effectively tailor the shell 10 to individual patient
conditions.
[0056] Another approach of the present invention obviates those
challenges and difficulties. According to alternative aspects of
the present invention, the shell 10 can be made from a transparent
material and the luting compound 60 can be made from a material
configured to have a color that mimics (i.e., generally corresponds
to) the color of the teeth, the gingival tissue, and/or the dental
prosthesis at or adjacent to the implantation site. Accordingly, if
a portion of the shell 10 extends above the soft-tissue socket 100,
the exposed portion of the shell 10 appears to be the color of the
luting compound 60 due to the transparency of the shell 10.
Advantageously, the shells 10 can thus be manufactured on a
commercial scale from a common, transparent material(s) and then
the luting compound 60 can be custom made or altered according to
the specific conditions of each patient. Because the luting
compound 60 can be more readily manufactured than the shell 10,
this approach can provide a more practical and commercially viable
approach to customized color matching for the arrangements and
methods of the present invention. Indeed, in some instances, the
luting compound 60 can be manufactured locally (e.g., chair-side)
by a patient's treating clinician for example. As such, the shell
10 and/or luting compound 60 can improve preservation of the
natural soft tissue architecture and provide a biologic seal
without compromising esthetics.
[0057] Non-limiting examples of suitable materials having
transparency (i.e., semi-transparent or fully transparent) for
making the shell 10 include poly(methyl methacrylate) (PMMA) (e.g.,
USP Class VI), polycarbonate, polysulfone, combinations thereof,
and/or the like. As additional non-limiting examples, the shell 10
can be made from a material configured to resorb such as, for
example, LACTOSORB manufactured by Biomet 3i (Palm Beach Gardens,
Fla.).
[0058] The luting compound 60 can be made from materials configured
to have a color that mimics or approximates the colors of the
adjacent teeth, gingival tissue, and/or dental prosthesis of the
patient. For example, the color of the healthy gingiva can vary
between pale pink, coral pink, light brown, dark brown and other
colors depending on a variety of patient specific factors such as
the amount of physiological melanin pigmentation in the patient's
epithelium, the degree of keratinization of the epithelium, and/or
the vascularity and fibrous nature of the underlying connective
tissue pigmentation. Similarly, for example, the color of the
adjacent teeth and/or dental prosthesis can have a wide variety of
shades and colors from white to reddish brown, yellow, reddish
yellow, or gray. According to aspects of the present disclosure,
the luting compound 60 can be made from one or more materials
and/or additives in various compositional proportions selected
based on an analysis of a patient's conditions, e.g., using shade
guides and/or photography. As non-limiting examples, the luting
compound 60 can made from polymerization materials (e.g., a
composite, acrylic, resin, etc.)
[0059] It is contemplated that, according to some aspects of the
present disclosure, the clinician can custom make the luting
compound 60 based on the analysis of the patient conditions.
According to additional and/or alternative aspects, the clinician
can select a luting compound from a plurality of premade luting
compounds 60 based on the analysis of the patient conditions. It
should be understood that, according to some additional and/or
alternative aspects of the present disclosure, the kit of shells 10
described above can include a plurality of different luting
compounds 60 having a plurality of different colors as well.
Alternatively, a plurality of different premade luting compounds 60
having a plurality of different colors can be provided as a
separate luting-compound kit.
[0060] Referring now to FIGS. 6, 8 and 9, an example process 200 is
illustrated for employing the shell 10 to preserve the soft-tissue
socket 100 and provide a biologic seal after tooth extraction
according to aspects of the present disclosure. In particular, the
example process 200 employs the shell 10 to form a temporary
soft-tissue-preservation, dental implant arrangement 2. While the
process 200 is described below for the extraction and replacement
of a single tooth, it should be understood that the described
method is not limited to a singular tooth and can be employed for
multiple teeth according to additional and/or alternative aspects
of the present disclosure.
[0061] At step 210, the diagnosis that a tooth requires extraction
is determined by a dental clinician. The diagnosis can be
performed, for example, based on clinical examination, radiographic
analysis, detailed past dental history, review of signs and
symptoms, combinations thereof, and/or the like.
[0062] At step 212, 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.
[0063] At step 214, a color for the luting compound 60 can be
determined to color match the luting compound 60 to the environment
in which the shell 10 will be utilized. In particular, the color of
the luting compound 60 can be determined from a plurality of
different potential colors based on an analysis of the patient's
teeth and/or gingival tissue (i.e., patient specific conditions).
For example, an analysis of a patient's teeth and/or gingival
tissue can be conducted using shade guides and/or the photos
obtained at step 212.
[0064] After the color of the luting compound 60 is determined at
step 214, the luting compound 60 can be prepared or selected at
step 216, in one non-limiting example, a plurality of different
luting compounds 60, each having a different color, can be provided
as a luting-compound kit such that one of the plurality of luting
compounds 60 in the luting-compound kit is selected based on the
analysis at step 214. In another non-limiting example, the luting
compound 60 can be made from one or more materials and/or additives
in various compositional proportions selected based on the analysis
at step 214. In either case, the prepared/selected luting compound
60 is configured to have a color that substantially matches or
mimics the gingival tissue and/or teeth of the patient. It is
contemplated that, according to some aspects, the luting compound
60 can alternatively have a color that substantially matches or
mimics the color of a dental prosthesis that may be employed in
conjunction with the shell 10 as described in greater detail, for
example, with respect to FIG. 7 below.
[0065] At step 218, a dental impression can be obtained by using
impression materials such as, for example, alginate, polyether,
vinyl polysiloxane, and other materials to establish an accurate
representation of the teeth and surrounding gingival tissues.
According to additional and/or alternative aspects, the dental
impression can be performed using a digital impression such as, for
example, cone beam computer tomography or digital oral impression
(CAD/CAM Digital Impressions) using a hand-held oral scanning
device of known design.
[0066] At step 220, an area of the mouth in which the tooth is to
be extracted is anesthetized with a dental local anesthetic
solution. A local anesthetic solution can be delivered to the area
either as a local infiltration dental injection or as a regional
nerve block to the area. The patient can be given adequate time
(e.g., 5 minutes) for the dental local anesthetic to anesthetize
the region of the mouth that is being treated.
[0067] At step 222, the tooth is extracted by a technique that
preserves the entire tissue-zone and minimizes trauma to the
supporting gingival tissues 106. For example, to preserve the
soft-tissue architecture of the immediate and surrounding gingival,
a flapless surgical technique can be used to extract the tooth. The
flapless surgical technique can include first incising the entire
supra-crestal attachment of the tooth 360 degrees around the tooth
(i.e., around soft-tissue socket 100) to disconnect the soft-tissue
attachment fibers. This can be accomplished, for example, using a
surgical blade, piezo-surgical instrument, micro-rotary dental
handpiece or dental laser soft-tissue cutting instrument.
[0068] The flapless surgical technique can also include dissection
of the supra-crestal attachment which includes the sulcular
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 110. Once the
supra-crestal fibers are released the superior periodontal ligament
fibers (attachment fibers found between the alveolar bone socket
102 and root surface) can next be incised. The superior periodontal
fibers attach the surface of the tooth (cementum) to the inner bony
socket can also be severed using minimal disruption to the
surrounding soft-tissue and bony architecture. This can be
accomplished by, for example, using micro-surgical instruments,
periotomes, a rotary diamond pointed diamond, piezo-surgical
instrument, laser. The instrument diameter can be between
approximately 20 microns to approximately 50 microns (or
approximately 1/8 to 1/4 millimeter in diameter) as this is the
typical dimension of the width of the periodontal ligament space.
The surgical instrument is placed into the entrance of the
periodontal ligament between the tooth 104 and inner socket wall
100. The periodontal attachment fibers are served around the tooth
to a depth of approximately 1 to approximately 4 millimeters,
depending on ease of entry into the periodontal ligament space.
[0069] The extraction of the tooth can be 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 bone socket 102.
[0070] When the extraction is performed using this example flapless
technique, minimal disruption can occur to the surrounding
soft-tissues of the gingival. The interdental papillae may not be
surgically altered from the pre-treatment condition. Incisors may
not be 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 been substantially altered other than the
severing of the attachment fibers between the root surface and
inserting fibers. It should be understood that, according to
alternative aspects of the present disclosure, the tooth can be
extracted using other techniques.
[0071] At step 224, any inflammatory granulation tissue can be
removed from within the bone socket 102, if necessary. This can be
performed using a small sized circular curette. Inspection can be
performed to ensure the integrity of the remaining inner socket
walls 100. A radiograph may be taken to determine the remaining
configuration of the tooth socket. This step can also be referred
to as preparing the bony socket or bone socket 102.
[0072] At step 226, a dental implant 30 is immediately placed
within the residual extraction socket 102. The term "immediately"
as used herein means that the implant 30 is placed shortly after
the bone socket 102 has been fully prepared to receive the implant
30 (e.g., within approximately 30 minutes) during the same
patient's visit. For example, the implant 30 can be placed
(vertically) at the level of the remaining crest of bone 110. Since
the remaining crest of bone 110 has different heights the implant
30 may be slightly supra-crestal at one region and slightly
subcrestal at another region of the bone socket 102. Additionally,
for example, the implant 30 can be further placed (horizontally)
with an axial position allowing for a screw-retained temporary. The
center axis of the implant 30 may be therefore placed in the
position of the cingulum of the adjacent teeth (i.e., positioning
the implant 30 toward the palatal (lingual) aspect of the residual
extraction socket 102). Positioning the implant 30 biased toward
the palatal (lingual) position of the extraction socket 102
facilitates use of a screw-retained immediate temporary
restoration.
[0073] This advantageous placement of the implant 30 is made
possible by the fact that the shell 10 is mechanically de-coupled
from the implant 30 (e.g., FIGS. 1-6 and 8) or otherwise allows for
a range of relative movement (e.g., FIGS. 10A-14B) and, thus, the
shell 10 need not be affixed with respect to the axis or position
of the implant 30 as has been common in the past. While the
embodiment described above employs a screw 50 for retaining the
post 40 to the implant 30, according to alternative
implementations, the immediate temporary can be configured to be
cemented to the substructure directly and place the location of the
micro gap below the soft tissue zone.
[0074] The implant 30 can mechanically engage and lock into a
portion of the bone. According to some aspects, this may be
achieved at the apical end of the implant 30. Additionally and/or
alternative, the mechanical engagement and locking to the bone can
be achieved on a lateral portion of the exterior of the implant
30.
[0075] According to aspects of the present disclosure, the diameter
of the implant 30 is smaller than the greatest diameter of the root
of the tooth that was removed. Therefore, the dissimilar diameters
between the implant 30 and the residual bony tooth socket 102
result in a "gap" or space between the residual bony socket 102 and
the exterior surface of the implant 30 as shown, for example in
FIG. 6. The gap allows a bone regenerative material to be placed
between the implant surface and the inner tooth socket buccal
plate. The gap also allows for fixture bone regeneration via the in
growth of the blood supply and new osteoblasts. It is important not
to use an 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. According to
aspects of the process 200, the preservation of the overlying
gingival and surrounding soft-tissues is preserved, at least in
part, by several factors: (1) a minimally invasive surgical
approach; (2) a shell 10 configured to preserve the soft-tissue
architecture; and (3) preservation and promotion to re-establish
the blood supply to the surrounding tissues.
[0076] At step 228, a screw-retained temporary post 40, such as the
PreFormance Post from Biomet 3i Dental Implants of Palm Beach
Gardens, Fla., is coupled to the dental implant 30 held within the
bone 102. It is contemplated that, according to alternative
aspects, other posts 40 can be employed (e.g., a cement retained
post).
[0077] At step 230, a shell 10 is selected according to
patient-specific conditions (e.g., for the proper vertical and
horizontal dimensions) as described above. Also, as described
above, the shell 10 can be supplied in a plurality of different
shapes and/or dimensions for selection based on the tooth to be
replaced (e.g., as a kit).
[0078] At step 232, the selected shell 10 is placed in the
soft-tissue socket 100. As described above, the shell 10 is
eccentrically positioned relative to the implant 30 so that an
outer surface 14 of the shell 10 makes physical contact with the
soft-tissue socket 100, achieving a biologic-seal between
soft-tissue socket 100 and the shell 10. To that end, the inferior
end (i.e., the first perimeter 16) of the shell 10 can be placed
into the soft-tissue socket 100 to make direct contact with the
implant head platform of the implant 30 within the bone 106. The
superior end (i.e., the second perimeter 18) can approximate the
free-gingival margin of the surrounding tissue-zone. The outer
surface 14 of the shell 10 makes direct contact with the inner
soft-tissue residual socket 100. Thus, the final adapted shell 10
substantially inhibits (or completely eliminates) any openings and
gaps between the soft-tissue socket 100 and the surrounding
gingival 108. As a result, a biologic-seal to the underlying
tissues below the surface is re-established.
[0079] Re-establishing the biologic seal can also provide
containment and protection for any bone regenerative materials
placed between the surface of the bone socket 102 and the surface
of the implant 30 filling the "gap" between the dissimilar
diameters of these two structures. If necessary a membrane (not
shown) can be placed at the level of the bony crest 110 and
placement of the shell 10 will provide complete coverage of the
membrane below providing a biologic-seal to the outer oral
environment.
[0080] The outer surface 14 of the shell 10 promotes soft-tissue
adhesion to the shell 10. According to some additional and/or
alternative aspects of the present invention, the outer surface 14
of the shell 10 can have a plurality of distinct surface texture
regions. For example, a superior (gingival) surface region can be
smooth to discourage the accumulation of plaque and an inferior
region can have an ordered microgeometric repetitive surface
texture or pattern. The superior smooth zone can extend 1 mm to 3
mm. The inferior textured region can cover the remaining outer
surface 14 of the shell 10. The textured surface of the inferior
region encourages the re-establishment of the gingival fibers to
make contact and adhere to the surface of the shell 10. For
example, the textured surface can have a regular micro-geometric
pattern that is uniform. It is also contemplated that the surface
texture can be modified chair-side using a rotary instrument, such
as a uniquely designed dental bur, that results in a ordered
micro-geometric repetitive surface pattern in the form of
alternating ridges and grooves, each having an unfixed width in an
alternating range of about 2 to about 25 microns (micrometers) and
a non-fixed or altering depth in a range of about 10 microns to
about 50 microns.
[0081] The surface texture is not limited to two or more texture
patterns, it is conceivable that the surface of the shell 10 be
design with a single texture covering the entire outer surface 14
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 textures described above have been shown to promote
soft-tissue preservation in combination with providing an effective
biologic-seal of the surface of the shell 10 to the residual soft
tissues.
[0082] At step 234, the luting compound 60 is employed to fixedly
couple the shell 10 to the post 40 (e.g., via a chair-side
technique). Generally, the entire inner surface 15 of the shell 10
is filled with the luting compound 60 as shown in FIGS. 6 and 8,
minimizing or eliminating voids or gaps within the luting compound
60.
[0083] According to some aspects, the post 40 can include a bore 46
to provide access to the screw 50 and allow for removal of the
shell 10 and post 40 from the implant 30. At step 236, a plug 80
can be inserted into the bore 46 of the post 40, as shown in FIG,
8, for final finishing and temporary insertion. The plug 80 is used
to temporarily plug the bore 46 of the post 40 before the luting
step so that access to a head 52 of a screw 50 can be reestablished
when a permanent tooth replacement is to be attached to the implant
30, or at other points in the process 200, by extracting the plug
80. As one non-limiting example, the plug 80 can be cylindrical
shaped and made from nylon.
[0084] In certain situations it may be necessary to modify the
shape of the shell 10 to properly adapt the shell 10 to the
soft-tissue socket 100. Accordingly, at step 238, the shell 10 can
be reshaped if necessary. For example, an additive technique of
material or a subtractive technique can be employed in which
additional materials are added to the shell 10 or a portion of the
shell 10 is removed.
[0085] To resurface the shell 10, a surface texture bur attached to
a standard rotary handpiece can be utilized. The surface texture
bur can be designed to re-establish the surface texture that was
created in the texture zone on the outer surface 14 of the shell
10. For example, the surface texture bur can be a rotary bur that
is designed to provide a microgeometric repetitive surface pattern
forming a varying widths and varying depths ranging from about 10
microns to about 50 microns. The irregular repetitive pattern can
be created using a chair-side rotary instrument on the surface of
the shell 10 to resurface the outer surface 14 of the shell 10.
[0086] The outer surface 14 of the shell 10 can be then cleaned to
ensure removal of all contaminants. For example, the shell 10 can
be cleaned by a high-pressure, high-heat steam cleaning and/or
autoclave, antimicrobial cleaning solutions may be applied to the
surface to detoxify the contaminated surface.
[0087] After filling and reshaping of the shell 10 is completed,
the shell 10 and the post 40 are removed from the implant 30 by
un-screwing the retaining screw 50 at step 240. The shell 10 and
the coupled post 40 are then cleaned and inspected and all voids
are filled and re-surfaced and cleaned as described above.
[0088] At step 242, a healing abutment can be coupled to the
implant 30. For example, a standard cylindrical healing abutment
composed of titanium, stainless steel, anodized metal or other
metal can be utilized. In another example, the cylindrical healing
abutment can be made from a polymer and disposed of after removal
to save costs. The healing abutment is selected to couple to the
implant 30 resulting in a noticeable gap between the outer surface
14 of the healing abutment and the bone socket 102. At step 244,
bone grafting materials can be placed within the gap between the
bone socket 102 and surface of the implant 30 at or below the crest
of bone 110. A barrier membrane can be positioned (if necessary)
before or after the bone grafting materials are placed in the gap.
At step 246, the healing abutment is removed and the contoured
refinished soft-tissue-preservation abutment formed by the luted
shell 10 and the post 40 inserted. The soft-tissue-preservation
abutment can be retained to the implant 30 by replacing the
retaining screw 50 and applying a seating torque to the screw 50
(e.g., between approximately 15 newton-centimeters to approximately
35 newton-centimeters).
[0089] Accordingly, the healing abutment can be used as
intra-operative component that is placed during the process 200 to
allow bone grafting materials to be placed within the gap between
the implant 30 and the bone socket 102. The healing abutment also
prevents the bone grafting materials from entering into a bore of
the implant 30 prior to the replacement of the shell 10 and the
post 40. The healing abutment can be a single use, disposable
component. It is contemplated that the healing abutment can be
fabricated from a variety of materials and come in a variety of
heights and widths. It is also contemplated that, according to some
aspects, one or more of the healing abutments can be included in
the kits described herein.
[0090] At step 248, the shell 10 can be adjusted to ensure that it
is not in occlusal contact with the opposing teeth 104 when the
patient closes their mouth. At step 250, a final radiograph can be
taken to assess the fit and position of the implant 30 and shell
10.
[0091] As a result of the process 200, the temporary
soft-tissue-preservation abutment formed from the shell 10 and the
post 40 creates a biologic-seal to the underlying soft tissue and
preserves the integrity of the surrounding gingival architecture.
According to some aspects, the temporary soft-tissue-preservation
abutment may retained in the soft-tissue socket 100 for at least
approximately 3-4 months at which time the fabrication of the final
prosthesis can be initiated.
[0092] Referring now to FIGS. 10A-14B, exemplary shells 310 are
illustrated according to alternative aspects of the present
invention. Each shell 310 is substantially similar to the shell 10
described and illustrated with respect to FIGS. 1-6, except instead
of the shell 10 being mechanically decoupled from the post 40 as in
FIGS. 1-6, the shell 310 is adjustably coupled to a post 340 prior
to a luting compound 60 being applied. That is, the shell 310 and
the post 340 are adjustably coupled prior to placement of the shell
310 in the soft-tissue socket 100 and attachment of the post 340 to
the implant 30. It has been found that adjustably coupling the
shell 310 and the post 340 in this manner can simplify the
placement of the shell 310 and the post 340 in the soft-tissue
socket 100 and the coupling of the post 40 to the implant 30.
[0093] As described above, it is important to allow the position of
the shell 310 to be determined by the soft-tissue socket 100 as
opposed to the position of the implant 30, which may be determined
by the bone socket 102 in which the implant 30 is placed.
Advantageously, the shell 310 can be independently positioned
relative to the implant 30 because the shell 310 is adjustably
coupled to the post 340 as opposed to fixedly coupled to the post
340 (prior to the luting compound 60 being applied). According to
aspects of the present invention, the shell 310 is adjustably
coupled to the post 340 by a plurality of spokes 342 that extend
from an inner surface 315 of the shell 310 to an outer surface 344
of the post 340. The spokes 342 are configured to allow adjustment
of the relative positions of the shell 310 and the post 340.
[0094] In the example illustrated in FIGS. 10A-10E, the plurality
of spokes 342 are provided as hinged arms that allow the post 340
to be moved and rotated in all directions (i.e., in the x-, y- and
z-directions and with freedom of rotation about all three axes).
For example, the hinged arms can be configured to bend, expand,
and/or compress in the x-, y-, and z-directions. In this way, the
range of relative movement and positioning between the shell 310
and the post 340 allows for the shell axis 12 and the implant axis
32 to be unaligned (in a manner similar to that described above for
the shell 10 of FIGS. 1-6 and 8) when the post 340 is coupled to
the implant 30 and the shell 340 is placed in the soft-tissue
socket 100.
[0095] The shells 310 illustrated in FIGS. 11A-14B provide
additional non-limiting examples of different configurations for
the plurality of spokes 342. While the shells 310 are illustrated
as having symmetric shapes, it should be understood that the shells
310 can have the shape(s) described above and illustrated with
respect to the shell 10 of FIGS. 1-8. In each example, the
plurality of spokes 342 provide simultaneous coupling and freedom
of movement between the shell 310 and the post 340. In the example
illustrated in FIGS. 11A-11B, the shell 310 is adjustably coupled
to the post 340 by two spokes 342, each having a single hinge
between the inner surface 315 of the shell 310 and the outer
surface 344 of the post 340. In the example illustrated in FIGS.
12A-12B, the shell 310 is adjustably coupled to the post 340 by two
spokes 342 configured as D-shaped members extending between the
inner surface 315 of the shell 310 and the outer surface 344 of the
post 340. In the example illustrated in FIGS. 13A-13B, the shell
310 is adjustably coupled to the post 340 by three spokes 342 in a
spiral configuration. In the example illustrated in FIGS. 14A-14B,
the shell 310 is adjustably coupled to the post 340 by three
spring-shaped spokes 342. Accordingly, it should be understood that
the plurality of spokes 342 can be provided in a wide variety of
configurations that adjustably couple the shell 310 to the post 340
to allow for simultaneous placement of the shell 310 and the post
340 in the soft-tissue socket 100 while still allowing the shell
310 to be independently positioned relative to the post 340 when
coupled to the implant 30.
[0096] It should be understood that the shell 310 adjustably
coupled to the post 340 can be employed utilizing the process 200
described above and illustrated in FIG. 9. Because the shell 310 is
adjustably coupled to the post 340, the shell 310 and the post 340
are placed in the soft-tissue socket 100 simultaneously. According
to some aspects, the shell 310 can be fully placed in the
soft-tissue socket 100 at the same time as the post 340 is coupled
to the implant 30. According to other aspects, the shell 310 can be
fully positioned in the soft-tissue socket 100 prior to the post
340 being coupled to the implant 30. According to still other
aspects, the post 340 can be coupled to the implant 30 prior to the
shell 310 being fully placed in the soft-tissue socket 100.
[0097] According to some aspects of the present disclosure, the
shell 310 can be made from the same materials described above with
respect to the shell 10 of FIGS. 1-9. That is, the shell 310 can be
made from a material having a color that is configured to
substantially match or mimic patient specific conditions or the
shell 310 can be made from a material having transparency (for use
with a luting compound 60 having a color that is configured to
substantially match or mimic patient specific conditions).
According to other aspects of the present disclosure, the shell 310
can be made of any biocompatible material(s) regardless of color or
transparency such as, for example, ceramic (e.g., zirconium oxide
ceramic), acrylic, porcelain, lithium disilicate, zirconia and
other crystalline structure. Additionally, it is contemplated that
the material of the shell 310 can include anti-microbial,
bacteriostatic properties to retard the growth or colonization of
the surface and internal surfaces with micro-organisms.
Non-limiting examples of such materials can include silver, copper,
magnesium, titanium, hydroxyapitite, etc. These anti-microbial,
bacteriostatic materials can be incorporated into the shell
material or may be applied to the shell surface forming a second
layer.
[0098] In the examples illustrated and described above for FIGS.
1-6, 8, and 10A-14B, the shells 10, 310 generally extend from the
crest of the bone 110 to approximately the height of the remaining
soft tissue 108. However, according to according to additional
and/or alternative aspects of the present disclosure, the shell 10,
310 can also be modified to provide a tooth form temporary 70. An
example tooth-form temporary (provisional) 70 is shown in FIG. 7.
The tooth-form temporary includes a subgingival transmucosal
section 72 that is based on the shell 10, 310 and a supragingival
section shaped like a tooth. The tooth-form temporary 70 extends
from the implant-platform of the luted shell 10, 310, and extends
from the outer perimeter 18 of shell 10, 310 beyond the level of
the free-gingival margin to the incisal edge or occlusal surface of
the dental tooth it is replacing.
[0099] The tooth-form temporary 70 can be provided in a plurality
of different vertical heights, elliptical shapes and different
dimensions to temporally replace the various types of teeth that
might be extracted. It is contemplated that the plurality of
tooth-form temporaries 70 can be provided as a kit in which a
variety of different sizes, shapes and types are available to
replace different teeth that are extracted. As non-limiting
examples, the tooth-form temporary 70 can be made of a material
such as polymethyl methacrylate (PMMA), polyetheretherketone
(PEEK), lithium disilicate, or zirconium dioxide.
[0100] As described above, the shells 10, 310 and the temporary
soft-tissue-preservation abutments formed therefrom of the present
disclosure can achieve a number of advantageous functionalities
with improved esthetics. In particular, the shells 10, 310 and the
temporary soft-tissue-preservation abutments preserve the soft
tissue architecture after the immediate removal of a tooth,
reestablish a biologic seal with the soft-tissue socket 100,
support the soft tissues to prevent collapse of bone and soft
tissue during healing, promote soft tissue adhesion by providing
direct physical contact between the temporary
soft-tissue-preservation abutment and the surrounding soft-tissue
socket 100, and/or retain bone regeneration materials in a gap
between the implant 30 and the bone socket 102. According to some
aspects, the process of forming the temporary
soft-tissue-preservation abutment can be simplified without
sacrificing the above-functionalities by precoupling the shell 310
and the post 340 in an adjustable manner. According to further
aspects, improved esthetics can be achieved forming the shells 10,
310 from a material having a color configured to mimic the
patient-specific conditions at an implantation site or forming the
shells 10, 310 from a material having transparency such that a
luting compound 60 having a color configured to mimic the
patient-specific conditions may be visible.
[0101] The emergence profile of the shell 10, 310 can have a
variety of profiles to compensate for the position of the implant
30 within the bone socket 102. Since the implant 30 may be
intentionally placed off-center from the extracted tooth, the shell
10, 310 can be intentionally placed eccentric to the implant 30
placed within the bone 102. That is, the shell 10, 310 can be
placed eccentric to the implant 30. The emergence profile of the
shell 10, 310 can be over-compensated and/or under-compensated in
the profile design allowing for the position of the implant 30. The
compensating emergence profile design and ability to place the
shell 10, 310 eccentric enables the re-establishment of an
effective biologic-seal between the outer surface 14 of the shell
10 and the soft-tissue socket 100. That is, the subgingival shape
of the soft-tissue-preservation abutment promotes biological socket
seal by providing either an over-contoured or an under-contoured
emergence profile to compensate for the position of the dental
implant 30 (e.g., in the vertical, horizontal, and buccal-lingual,
mesial-distal angulations) and provide an adequate soft tissue seal
between prosthesis and soft-tissue socket 100 to support the soft
tissues to preserve the natural architecture of the gingival
tissues.
[0102] Each of these embodiments and obvious variations thereof is
contemplated as falling within the spirit and scope of the claimed
invention, which is set forth in the following claims. Moreover,
the present concepts expressly include any and all combinations and
subcombinations of the preceding elements and aspects.
* * * * *