U.S. patent number 3,913,229 [Application Number 05/445,678] was granted by the patent office on 1975-10-21 for dental treatments.
This patent grant is currently assigned to Miter, Inc.. Invention is credited to Thomas D. Driskell, Alfred L. Heller, Joseph F. Koenigs.
United States Patent |
3,913,229 |
Driskell , et al. |
October 21, 1975 |
Dental treatments
Abstract
Dental methods and materials are disclosed for treating diseased
or traumatized teeth and peridontal tissues. Physiologically
compatible and soluble calcium phosphate compounds are prepared
into a porous aggregate paste or powder and positioned adjacent to
calcified tissue in contact with a blood supply. Such a technique
permits improved methods for pulp capping procedures, root canal
procedures, tooth replanting procedures and for corrective
peridontal procedures.
Inventors: |
Driskell; Thomas D.
(Worthington, OH), Heller; Alfred L. (Worthington, OH),
Koenigs; Joseph F. (Columbus, OH) |
Assignee: |
Miter, Inc. (Worthington,
OH)
|
Family
ID: |
23769809 |
Appl.
No.: |
05/445,678 |
Filed: |
February 25, 1974 |
Current U.S.
Class: |
433/228.1;
106/35 |
Current CPC
Class: |
A61K
6/847 (20200101); A61K 6/56 (20200101); A61K
6/54 (20200101); A61K 6/876 (20200101); A61K
6/838 (20200101); A61K 6/69 (20200101); A61K
6/52 (20200101); A61K 6/54 (20200101); C08L
23/20 (20130101); A61K 6/54 (20200101); C08L
7/00 (20130101); A61K 6/56 (20200101); C08L
23/20 (20130101); A61K 6/56 (20200101); C08L
7/00 (20130101); A61K 6/56 (20200101); C08L
23/20 (20130101); A61K 6/56 (20200101); C08L
7/00 (20130101); A61K 6/54 (20200101); C08L
23/20 (20130101); A61K 6/54 (20200101); C08L
7/00 (20130101) |
Current International
Class: |
C01B
25/00 (20060101); C01B 25/32 (20060101); A61C
5/00 (20060101); A61K 6/00 (20060101); A61K
005/01 () |
Field of
Search: |
;32/1,12,15,57,10
;128/92C,92G ;106/38.9,35 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Peshock; Robert
Assistant Examiner: Lever; J. Q.
Attorney, Agent or Firm: Foster; Frank H.
Claims
We claim:
1. A method for enabling the naturally functioning growth of at
least one of the following: fibroblasts, odontoblasts,
cementoblasts and osteoblasts, said method comprising positioning a
porous mass of a physiologically soluble and compatible calcium
phosphate compound adjacent the calcified tissues of a tooth and in
contact with a blood supply sufficient to permit the formation of a
blood clot in said calcium phosphate compound.
2. A method according to claim 1 wherein said calcium phosphate
compound comprises CaHPO.sub.4.
3. A method according to claim 1 wherein said calcium phosphate
compound comprises .alpha. phase Ca.sub.3 (PO.sub.4).sub.2.
4. A method according to claim 1 wherein said calcium phosphate
compound comprises .beta. phase Ca.sub.3 (PO.sub.4).sub.2.
5. A method according to claim 1 wherein said calcium phosphate
compound comprises a mixture of at least two of the following
compounds: .alpha. phase Ca.sub.3 (PO.sub.4).sub.2 ; .beta. phase
Ca.sub.3 (PO.sub.4).sub.2 ; and CaHPO.sub.4.
6. A method according to claim 1 for enabling the regeneration of
calcified and peridontal tissue said method more particularly
comprising the steps of:
a. preparing a diseased site by excising diseased tissue of at
least one of the above types and forming a cavity so as to
communicate with a blood supply;
b. at least partially filling the interior of said cavity with said
physiologically soluble and compatible calcium phosphate compound
in a configuration in contact with said blood supply; and
c. closing the cavity by filling it and rebuilding its outer
functional surface.
7. A method according to claim 6 wherein said calcium phosphate
compound comprises CaHPO.sub.4.
8. A method according to claim 6 wherein said calcium phosphate
compound comprises .alpha. phase Ca.sub.3 (PO.sub.4).sub.2.
9. A method according to claim 6 wherein said calcium phosphate
compound comprises .beta. phase Ca.sub.3 (PO.sub.4).sub.2.
10. A method according to claim 6 wherein said calcium phosphate
compound comprises a mixture of at least two of the following
compounds: .alpha. phase Ca.sub.3 (PO.sub.4).sub.2 ; .beta. phase
Ca.sub.3 (PO.sub.4).sub.2 ; and CaHPO.sub.4.
11. A method according to claim 1 wherein said calcium phosphate
compound is prepared by sintering together particles of said
compound into a unitary body; then grinding said body into a grated
particulate; then adding a vehicle to said powder in sufficient
quantity to form a putty-like mixture for filling into said
cavity.
12. A method according to claim 11 wherein said powder consists
substantially of particles which are ground sufficiently small that
the putty-like mixture exhibits colloidal properties.
13. A method according to claim 1 for performing a pulp capping
procedure which enables the formation of a dentinal bridge in a
tooth, said method comprising:
a. preparing said tooth by removing diseased tissue thereby
creating a cavity communicating from the tooth surface to the
pulpal tissue, and in fluid communication with the blood supply of
remaining healthy tooth pulp;
b. at least partially filling the interior of said cavity with a
physiologically soluble and compatible calcium phosphate compound
in a configuration having at least a portion thereof in contact
with said blood supply; and
c. forming a protective, relatively hard cover sealing the surface
opening of said cavity.
14. A method according to claim 13 wherein said calcium phosphate
compound comprises CaHPO.sub.4.
15. A method according to claim 13 wherein said calcium phosphate
compound comprises .alpha. phase Ca.sub.3 (PO.sub.4).sub.2.
16. A method according to claim 13 wherein said calcium phosphate
compound comprises .beta. phase Ca.sub.3 (PO.sub.4).sub.2.
17. A method according to claim 13 wherein said calcium phosphate
compound comprises a mixture of at least two of the following
compounds: .alpha. phase Ca.sub.3 (PO.sub.4).sub.2 ; .beta. phase
Ca.sub.3 (PO.sub.4).sub.2 ; and CaHPO.sub.4.
18. A method for enabling the naturally functioning growth of at
least one of the following: fibroblasts, odontoblasts,
cementoblasts and osteoblasts, said method comprising positioning a
physiologically soluble and compatible calcium phosphate compound
adjacent the calcified tissues of a tooth and in contact with a
blood supply sufficient to permit the formation of a blood clot in
said calcium phosphate compound said method more particularly
comprising a root canal procedure for the apexification of an open
apex tooth root said procedure comprising:
a. forming an access opening into a tooth pulp chamber through the
crown portion of a tooth;
b. cleansing and shaping said pulp chamber including the root canal
portion and extending it to communication with a fresh blood
supply;
c. filling an extreme apical part of said root canal portion with
said physiologically soluble and compatible calcium phosphate
compound; and
d. filling the remainder of the chamber with a filling material and
forming a relatively hard protective cover at said access
opening.
19. A procedure according to claim 18 wherein said procedure
further comprises the steps of:
a. initially filling said pulp chamber with a relatively soft,
temporary filling material;
b. after approximately a five month period, removing said
protective cover and said temporary filling material,
biomechanically cleansing the internal portion of the root canal;
and
c. filling said chamber with a dense permanent filling material and
forming a relatively hard protective cover at said access
opening.
20. A method according to claim 19 wherein said calcium phosphate
compound comprises CaHPO.sub.4.
21. A method according to claim 19 wherein said calcium phosphate
compound comprises .alpha. phase Ca.sub.3 (PO.sub.4).sub.2.
22. A method according to claim 19 wherein said calcium phosphate
compound comprises .beta. phase Ca.sub.3 (PO.sub.4).sub.2.
23. A method according to claim 19 wherein said calcium phosphate
compound comprises a mixture of at least two of the following
compounds: .alpha. phase Ca.sub.3 (PO.sub.4).sub.2 ; .beta. phase
Ca.sub.3 (PO.sub.4).sub.2 ; and CaHPO.sub.4.
24. A procedure according to claim 19 wherein said calcium
phosphate compound is also forcibly extruded out through the open
tooth apex when being filled into said root canal.
25. A method for enabling the naturally functioning growth of at
least one of the following: fibroblasts, odontoblasts,
cementoblasts and osteoblasts, said method comprising positioning a
physiologically soluble and compatible calcium phosphate compound
adjacent the calcified tissues of a tooth and in contact with a
blood supply sufficient to permit the formation of a blood clot in
said calcium phosphate compound said method more particularly
comprising a procedure for replanting an avulsed tooth, said
procedure comprising:
a. coating said calcium phosphate compound onto the exterior
surface of the root portion of said tooth; and
b. replanting said tooth in its natural socket.
26. A method according to claim 25 wherein said calcium phosphate
compound comprises CaHPO.sub.4.
27. A method according to claim 25 wherein said calcium phosphate
compound comprises .alpha. phase Ca.sub.3 (PO.sub.4).sub.2.
28. A method according to claim 25 wherein said calcium phosphate
compound comprises .beta. phase Ca.sub.3 (PO.sub.4).sub.2.
29. A method according to claim 25 wherein said calcium phosphate
compound comprises a mixture of at least two of the following
compounds: .alpha. phase Ca.sub.3 (PO.sub.4).sub.2 ; .beta. phase
Ca.sub.3 (PO.sub.4).sub.2 ; and CaHPO.sub.4.
Description
BACKGROUND OF THE INVENTION
This invention relates generally to dental procedures for treating
various trauma and disease conditions. More particularly this
invention relates to materials and treatment procedures for
enabling the growth of certain tissues to provide repairs of
improved efficacy, predictability and longevity.
With many types of dental treatments or procedures, it is desirable
that the human body regenerate tissues in order to restore health
and function to diseased or traumatized teeth, peridontal tissues,
or supportive bone. This is true for example, with pulp capping
procedures, root canal procedures, corrective peridontal procedures
and tooth replanting procedures.
Pulp capping treatment is used where there has been an exposure or
opening into the pulp chamber of the tooth because the pulp has
been insulted by disease or injury. An exposed pulp will become
hyperemic, infected and devital if left untreated. The pulp capping
procedure involves the placing of a material in the opening. This
material should reduce the inflammation and allow the pulp to heal.
Additionally, it should cause a dentinal bridge to be laid down
spanning the opening into the pulp chamber via odontoblastic cells
of the pulp.
Many different agents have been used as pulp capping materials with
various degrees of success. Such agents include charcoal, ivory
chips, sulfa drugs, a variety of antibiotics, anti-inflammatory
corticoides, zinc-oxide-eugenol, calcium hydroxide and formocresol.
At the present time, zinc oxide-eugenol and calcium hydroxide are
the two materials most commonly employed in pulp capping treatment
of adult teeth.
Although calcium hydroxide can cause formation of a calcified
bridge, such a calcium hydroxide induced bridge is usually not
continuously connected from one side of the defect to the other.
Usually an opening or hole remains in the calcium hydroxide induced
bridge forming an avenue which may leak and may permit the passage
of saliva and bacteria into the pulp chamber causing infection and
inflammation of the pulp. It is known also, that a calcified bridge
induced by calcium hydroxide often breaks down eventually,
resulting in pulpal necrosis.
Thus a need exists for a material and procedure which will
consistently permit the formation of a healthy system of
odontoblasts to form and maintain a permanent and continuous,
protective, dentinal layer or bridge impervious to noxious
stimuli.
If focal disease within a tooth pulp is not treated soon enough,
the pulp will become totally diseased and necrotic. Necrosis of the
diseased pulp will cause the emission of toxic products through the
apex of the tooth root, producing inflammation of peridontal
tissues, and frequent abcess formation. Such a condition will often
initiate resorption of the root with destruction of the apex. In
devital teeth which have undergone a significant degree of root
resorption, the resultant open apex makes filling and sealing of
the root canal with a dense material virtually impossible unless
retrograde surgical procedures are employed. A similar, open apex,
condition exists in young devital teeth which have not yet
developed closed apices.
If an open apex tooth is cleaned out with files and an attempt is
made to fill it, there is nothing against which to pack the filling
material. Therefore the root canal may not be hermetically sealed
by merely packing in a filling material. A non-sealed root canal
will leak and allow the exchange of tissue fluids, metabolic
breakdown products and probably initiate a chronic inflammatory
condition. After two to four years many open apex root canals,
treated but not properly sealed, break down with the periapical
tissues becoming reinfected, possibly with the formation of another
abcess.
The purpose of this type of root canal procedure, is to provide a
wall at the apex against which a dense filling material may be
packed thus preventing leakage or the ingrowth of undesirable cell
structures into the root canal.
There presently are three basic techniques used in the endodontic
treatment of nonvital teeth with open apices. The first is to gain
access to the tooth apex surgically and mechanically close the
apical opening through the insertion of a retrograde filling
material, generally amalgam. The second is to introduce a filling
material into the root canal by way of an occlusal access opening
and obturate or fill the root canal. This filling material is
generally gutta-percha. The third technique is to induce apical
closure by placing a medicated dressing within the root canal. This
dressing is conventionally a mixture containing calcium
hydroxide.
The third technique does produce some continued apical development
and restriction. However, a substantial number of cases have been
observed which do not respond to such treatment. Even after
continuous treatment of 2 years and longer, there are cases which
have not responded favorably. When apical closure is not obtained,
endodontic failure often occurs due to the recurrence of an acute
inflammatory condition. This condition historically dictates
surgical intervention for the placement of a retrograde filling or
the extraction of the tooth.
There is therefore a need for a technique and material which can
reliably provide the physiological closure of an open apex tooth
against which a filling material may be packed to obtain a
permanent and complete seal.
The peridontal ligament and periapical bone, supporting the
involved tooth, is often lost in the immediate area of the apex.
Conventionally, no separate definitive treatment is administered to
allow for specific regeneration of these tissues. Healing or
regeneration normally proceeds in these areas after the infective
process has been eliminated. However, peridontal ligament fibers
which are regenerated do not reorient themselves in the same
fashion found prior to their destruction.
Thus, functional forces and stresses, placed upon endodontically
treated teeth, are not properly transmitted to the supporting bone.
This lack of proper force transmission, allows a chronic
inflammatory process to persist in the immediate area of the tooth
root apex. Bone is never fully regenerated under such
circumstances. In fully 92 per cent of all endodontically treated
teeth, a chronic inflammatory process or condition exists in the
immediate area of the root apex.
There is therefor a need for a treatment and material which would
allow for the re-establishment of a peridontal ligament with
normally oriented fibers, thus allowing for the transmission of
forces to the supporting bone, with possible elimination of the
chronic inflammatory condition and establishment of a more normal
bone level or pattern about the root apex.
In still another dental procedure, a dentist is occasionally called
upon to replant a tooth which has been accidentally avulsed from
the mouth, for example, through an athletic inuury. Even when such
a tooth is replaced within the first few minutes, resorption of the
root usually begins which results in eventual loss of the tooth.
There is therefore a need for a material and a technique to enable
a dentist to replant avulsed teeth with the elimination of
subsequent root resorption.
SUMMARY OF THE INVENTION
Most broadly defined, the method of the present invention comprises
the positioning of one or a plurality of physiologically soluble
and compatible calcium phosphate compounds in various forms
adjacent to various radicular and periapical calcified tissues and
in contact with a blood supply, sufficient to permit formation of a
blood clot in the calcium phosphate compounds. The invention
contemplates the positioning of the calcium phosphate compounds at
both the interior and the exterior of a tooth as described more
particularly in the following discussion. The method of the present
invention enables the growth of the appropriate tissue elements;
fibroblasts, odontoblasts, cementoblasts, and osteoblasts, at the
appropriate sites, where needed, in or around a treated tooth.
It is therefore an object of the invention to enable the
regeneration of tissues in a manner which provides a substantially
permanent repair of a tooth and its supporting structure permitting
normal function.
It is another object of the invention to provide an improved pulp
capping technique.
Still another object of the invention is to provide an improved
root canal technique.
Yet another object of the invention is to provide an improved
technique for replanting teeth.
Further objects and features of the invention will be apparent from
the following specification and claims when considered in
connection with the accompanying drawings illustrating several
embodiments of the invention.
DETAILED DESCRIPTION
The following particular dental procedures are described as
examples of techniques embodying the present invention. The
material used in the following techniques are physiologically
soluble and physiologically compatible calcium phosphate compounds.
The most effective materials are high purity forms of
.alpha.Ca.sub.3 (PO.sub.4).sub.2 and .beta.Ca.sub.3
(PO.sub.4).sub.2, commonly known as whitlockite and CaHPO.sub.4,
commonly known as Brushite and mixtures thereof. However, other
calcium phosphate compounds are contemplated. We have found that
CaH.sub.4 (PO.sub.4).sub.2 does not work because it does not meet
the above definition.
In the family of calcium phosphate compounds defined as above, the
invention contemplates the use of those compounds which have
minimal or no harmful effects on the human body and additionally
have a strong tendency to go into solution as calcium and
phosphorous in body fluids to be either retained in or eliminated
from one body.
Although these materials may be used in the form of small crystals
or ground into a suitable powder, it has been found particularly
desirable to sinter particles of the desired material into porous
blocks and then grind the blocks into a granular material. This
sintering and subsequent grinding improves the porosity of the
granular material. Sterile water, normal physiological saline
solution, methyl cellulose or other suitable vehicle, is then mixed
in sufficient quantity with the finer forms of granular powder to
form a putty-like mixture. This putty-like paste form of the
preferred materials, is advantageous for use in performing
procedures of the present invention. It is very plastic and
consequently, is easy to use. The smaller the particles are ground
from the sintered block the more plastic and consequently the more
advantageous the material becomes. It is also particularly
desirable that the powder be ground into particles so small that
the surface forces become an important factor in determining its
properties, approaching colloidal properties.
PULP CAPPING TECHNIQUE
In performing the pulp capping procedure according to the present
invention, the tooth is prepared by removing decay and diseased
tooth structures until sound hard dentin and viable pulp tissue is
present. In this manner, the diseased tissue is cleaned out with,
for example, a dental bur or excavator and occasional irrigation
using substantially conventional dental skills and techniques. The
cavity formed in this manner must extend into communication with a
blood supply. There must therefore be bleeding from a portion of
the pulp.
The size of the pulpal opening and the amount of diseased pulp
tissue removed is, of course, dependent upon the extent to which
the diseased pulpal condition has progressed. The size may vary
from a minor insult upon the pulp to a pulpotomy which is the
removal of all the coronal pulp down to the orifice of the root
canals leaving only the pulp tissue in the root canal.
A layer of the dry granular powder or putty-like material,
described above, is then laid upon the bleeding pulp as a pulp
capping agent. This layer may be 1mm to 2mm thick. Upon this layer,
a dental base material is placed. Carboxylate cement or zinc ozide
eugenol preparations have been used. The dental base, or cement
layer keeps the pulp cap in place, provides some insulation and
presents forces from being exerted directly upon the pulp cap and
the pulp tissues while placing an amalgam or other restoration upon
the tooth.
According to our best current opinion, the pulp capping agent
operates in the following manner. Blood from the bleeding pulp
seeps into the calcium phosphate compound and forms a blood clot
having fibrin fibrils. Endothelial cells are then laid down to form
a vascular blood supply within the porous aggregate of the capping
agent. Undifferentiated mesenchymal cells then migrate out of the
walls of the blood vessels into the matrix of the pulp capping
agent. These cells differentiate into fibroblasts or odontoblasts
which begin laying down colagen, which in turn subsequently
mineralizes. Calcifications are observed around and entrapping the
particles of pulp capping agent.
Simultaneously, with this intramatrical proliferation of tissue,
the pulp capping agent, according to the present invention, is
slowly being resorbed. As time progresses, the calcifications
become thicker and eventually replace the pulp capping agent and
form a continuous and protective bridge. Eventually, after
sufficient maturation, the cells adjacent to the pulpal aspect of
the bridge appear to be true odontoblasts which lay down what
appears to be secondary dentin.
It was observed that with treatment according to the present
invention, the odontoblasts of the pulp tends to remain in close
association with the tissue of the dentinal bridge. With the
conventional pulp capping techniques, the pulp often retreats from
the bridge as from a foreign body and local foci of necrosis are
often seen as well as internal resorption of the root canal
walls.
PULP CAPPING EXPERIMENTS
Twenty-eitht teeth of four cynalmolgus monkeys were used in this
experiment. Radiographs were taken before and after each
pulp-capping procedure. Molars and pre-molars were selected as
teeth of choice because of their larger pulp chambers. Upper right
first molars and upper right pre-molars were used as control teeth
utilizing calcium hydroxide. .beta.-phase tricalcium phosphate was
used in the remaining molar and pre-molar teeth as the pulp capping
agent.
The animals were anesthetized with Sernylan and Pentobarbitol.
Atropine was used to decrease saliva flow. The teeth were isolated
under rubber dam and disinfection was attempted using Betadine
solution for five minutes. The occlusal portion of the vital tooth
was opened with a high speed No. 4 round bur. This same bur was
used to remove the roof of the pulp chamber. The vital pulp tissue
of the chamber was removed with a small spoon excavator hoping to
reduce injury to the remaining vital pulp tissue in the root
canals. After the pulpotomy was completed, hemorrhage was
controlled with a sterile cotton pellet. Pressure was applied until
a blood clot formed on the canal tissue stumps. Excess blood and
clot were rinsed from the chamber with physiological saline.
Calcium hydroxide powder plus physiological saline was mixed into a
paste and used as the control pulp-capping material. .beta.-phase
tricalcium phosphate powder and physiological saline was mixed into
a similar type paste. Calcium hydroxide paste was used in seven
teeth and .beta.-phase tricalcium phosphate paste was used in
twenty-one teeth. Pulpal hemorrhage was controlled by pressure
application of sterile cotton pellets followed by the application
of the pulp capping materials on the exposure site. Due to
evaporation of the saline solution, it was difficult to place the
same amount of paste over each exposure site.
After the calcium hydroxide or tricalcium phosphate paste was
placed as the pulp-capping agent, a mix of fast setting zinc oxide
eugenol was used to form a protective base before the placement of
the final amalgam restoration. Care was taken to attempt to place
the zinc oxide eugenol base without pushing the pulp-capping
materials into the remaining pulpal tissues.
The monkeys were anesthetized with Sernylan and sacrificed by
profusion with 10 per cent formalin to allow 2, 3, 5, 8, 16 and 24
weeks studies to be considered. After death the mandible and
maxilla were removed, stripped of soft tissue and sectioned so one
tooth remained in each section. After fixing the block section in
10 per cent formalin for two weeks, the sections were demineralized
in 5 per cent formic acid. The specimens were then imbedded in
paraplast and cut serially at 6-10 microns. Each section was cut
longitudinally in a mesio-distal plane. Every fifth section was
stained routinely with hematoxylin and eosin stain and examined
microscopically. In areas of importance to the study, every section
was stained.
Before the pulp-capping procedures were started or before the
animal was sacrificed, a clinical evaluation of the tissue was
completed. No fistulas were found before or after the procedures.
The gingival tissue was classified from as mild to severe
inflammation which is common among the monkey population due to the
large amount of calculus present. Radiographs were taken before the
pulp-capping procedures, immediately following the procedure and at
time of animal sacrifice. No abcess formations were evident on the
radiographs. Due to the small pulp canals it was very difficult to
conclude that the radiographs showed evidence of a protective
bridge; either with calcium phosphate or calcium hydroxide. The
following results are histological evidence of the specimens.
2 week post-op experimental
Three specimens were used. The specimens showed evidence of a
calcified matrix formation. There was no evidence of a calcified
bridge. There was a characteristic "compartmenization" that is
evident from the two-week through the twenty-four week studies.
These compartments appear to be areas of connective tissue
surrounding the calcium phosphate particles with evidence of large
amounts of blood supply. The compartments give the appearance of a
"basket-weave" with the connective tissue and calcium phosphate
particles weaving through out the coronal portion of the canal. The
inflammation index was low, the odontoblasts are viable, and blood
supply was evident in great quantity. There was evidence of a
thickened pre-dentin layer. The periapical tissue was healthy and
without inflammation.
2 week post-op control
Two specimens were used. One specimen showed complete necrosis
through out the pulp chamber and canals. The other specimen showed
evidence that a calcified matrix was starting to develop.
Inflammation was evident in the coronal portion of the pulp canals.
Inflammation was not present in the periapical tissues. The
odontoblasts appear normal with no thickening of the predentin
layer.
3 week post-op experimental
Three specimens were used. Each specimen showed similar results
compared to the two-week specimen except that there was evidence of
a more developed matrix forming over the exposed pulp. A low index
of inflammation was present in the coronal portion of the pulp but
not evident in the apical portion of the pulp. There was evidence
of a thickened pre-dentin layer continuous with the calcifying
matrix. Vascular supply was evident through out the pulpal tissue.
The odontoblasts were healthy and appeared to be functioning.
3 week post-op control
One specimen was used. There was evidence of a calcified matrix
band starting to form. It was more mature than the two-week
specimen. Inflammation was present in the coronal portion of the
pulp canal but was not seen in the periapical tissue. Particles of
calcium hydroxide powder was evident apical to the area where the
calcified matrix was forming. The odontoblasts and pre-dentin layer
appear normal and functioning.
5 week post-op experimental
Four specimens were used. There was evidence of a calcified matrix
formation. The matrix appears well defined with thicker walls
surrounding the remaining calcium phosphate than was evident in the
three-week study. The characteristic "compartmenization" is every
evident. It appears that the calcium phosphate crystals are being
phagocytized or go into solution within the matrix compartment. All
four specimens showed viable odontoblasts with thickening
pre-dentin layer continuous with the calcified matrix. Some areas
of the predentin contain cells which appear to be entrapped
odontoblasts. These odontoblasts appear healthy and viable. The
thickened pre-dentin layer and calcified matrix form a continuous
cap over the exposed pulp. Histological serial sections show the
calcified matrix to be a complete layer from one side to the other
side of the canal. Blood vessels are numerous through out the
compartmentized matrix, Periapical and apical pulp tissue appear to
be void of inflammation.
5 week post-op control
One specimen was used. The specimen showed a well developed bridge
was formed. Histological serial examination did show the bridge was
not complete from wall to wall of the canal. The pre-dentin layer
was thickened and continuous with the calcified bridge.
Odontoblasts adjacent to the coronal portion of the bridge are few
in number. There is evidence of a "void" area beginning adjacent to
the thickened pre-dentin layer and inferior to the calcified
bridge. Apical odontablasts appear to be viable with a small amount
of pre-dentin thickening. Blood vessels appear to be few in
number.
8 week post-op experimental
Three specimens were used. The calcified matrix is more mature with
evidence of less calcium phosphate particles in the individual
compartments. Viable cells, perhaps fibroblasts or ostoid-producing
cells are evident within areas of the matrix. The odontoblastic
layer is very healthy from the matrix to the apex. The pre-dentin
layer is thickened only at the coronal portion where it unites with
the calcified matrix. The pulpal tissue is very healthy,
noninflammatory and is supplied by many blood vessels. Histological
serial sections show the calcified matrix is complete in two
specimens from side to side of the canal. The other specimen is
almost complete from side to side of the canal. Periapical tissue
is healthy and shows no inflammation.
8 week post-op control
One specimen was used. There was evidence of a calcified bridge.
Histological serial sections, however, showed that the bridge was
not complete from side to side of the canal as tissue was evident
in some sections. Odontoblasts from the bridge apically to the apex
showed areas of vacoules believed to be death of these cells. There
was no evidence of thickening of the predentin layer below the
bridge. The pulp tissue showed a fatty degeneration center with
areas of scattered necrosis. An abcess was forming under one area
of the bridge in several histological sections. Very few blood
vessels were evident. The periapical tissues had a low index of
inflammation.
16 week post-op experimental
Three specimens were used. One specimen showed complete necrosis
through out the chamber and canal but the periapical tissue had a
low index of inflammation. The other two specimens showed the
characteristic compartmenization of the calcified matrix. Most of
the calcium phosphate particles have resorbed within the
compartments allowing for thicker, more mature matrix walls. The
pre-dentin is thickened and continuous with the calcified matrix
forming a complete histological serial bridge from wall to wall of
the canals. Viable cells are evident within the matrix proper. The
pulpal and periapical tissues are healthy and without inflammation.
The odontoblasts are viable and uniform in position. Many blood
vessels are evident through out the pulpal tissue as well as within
the compartmenized matrix.
16 week post-op control
One specimen was used. A calcified bridge was formed which was
complete in histological serial section from wall to wall of the
canal. The pupal and periapical tissue appeared healthy with no
evidence of inflammation. The pre-dentin area showed slight
thickening. The odontoblasts appear healthy and uniform in
position. Normal amount of blood vessels are observed through out
the pulpal tissue.
24 week post-op experimental
Three specimens were used. All three teeth showed the same results.
Proceeding from the coronal to the apical portion of the canal; the
most coronal portion of the pulpcap showed very little evidence of
remaining calcium phosphate. The characteristic compartmenization
was much smaller with well defined calcified matrix walls. Viable
cells were evident within the walls of the calcified matrix. Blood
vessels were evident through out the matrix and compartments.
Directly under the calcified matrix compartments was an area of
scattered solid calcifications mixed with many blood vessels.
Proceeding apically was an area of complete calcification which
made a bridge that histologically in serial sections showed to be a
complete bridge from wall to wall of the canals. This bridge showed
evidence of a few viable cells. Under the calcified bridge was
found an area of thickened pre-dentin that was continuous with the
thickened pre-dentin area from the sides of the canal walls. The
pre-dentin thickened portion was complete through out from side to
side of the canals. Directly under the pre-dentin layer was found
odontoblasts that were lined up in direct apposition to the
pre-dentin layer adjacent to the calcified bridge. The odontoblasts
are viable and functional as evidence by the pre-dentin thickness.
A few small calcified bodies are evident in apposition to the
coronal odontoblasts. The pulpal tissue is very healthy, numerous
with blood vessels and shows no signs of inflammation. The
periapical tissues are also healthy and highly vascular.
24 week post-op control
One specimen was used. The specimen showed complete necrosis of the
pulp chamber and pulp canal. There was evidence of periapical
inflammation and possible periapical abcess formation. It was not
possible to tell if a bridge had once been formed.
From these experiments it appears that the .beta. phase tricalcium
phosphate was more predictable in forming a dentinal bridge.
Success was observed in the teeth pulp capped with tricalcium
phosphate. While only one of the twenty-one teeth treated with
.beta. phase tricalcium phosphate was considered a failure, three
of the seven teeth treated with calcium hydroxide had totally
failed and another was failing.
Calcium hydroxide also seems to cause or allow internal resorption
of the dentin to take place. No such internal resorption has been
seen with the teeth treated with tricalcium phosphate. In fact, no
adverse affects have been seen.
The pulp capping technique described above has been performed on
approximately 30 human teeth. To date, the teeth are vital,
asymptomatic, and are in function.
ROOT CANAL TECHNIQUE
As briefly described above, the root canal procedure is used for
the apexification of young devital teeth or the apexification of
devital, mature teeth that have undergone apical root resorption.
An advantage of the procedure now described is that the root canal
procedure may be accomplished without surgery.
An acess opening is made through the crown portion of the tooth on
the lingual or occlusal aspect. The access opening must be large
enough and contoured properly so that when the dentist instruments
to the apex with files, no interference is met. The instruments
must be positioned so that the entire interior portion of the root
canal down to the open apex is biomechanically cleansed and shaped.
This is done according to standard dental practice through a
combination of filing and intermittent irrigation using a material
which will dissolve necrotic debris and remove break down products.
Once the walls are relatively smooth and the interior of the tooth
free of necrotic dentin and pulp, resolution of the abcess will
usually proceed.
In cleaning the interior of the tooth roots, progressively larger,
endodontic files are used. The largest file, for example, might
have a diameter of 0.8 millimeters. A physiologically compatible
and soluble calcium phosphate compound preferably prepared as
described above is then packed into the apical 3 or 4 millimeters
of the root canal. Preferably, the calcium phosphate compound is
"pushed" so that it is slightly extruded out of the open apex, and
allows blood to infiltrate the calcium phosphate.
As an alternative to extruding the calcium phosphate compound by
"packing," the compound may be positioned exteriorly of the root by
injecting some of the material out of the bottom of the tooth root
prior to packing the interior of the apex.
A relatively soft temporary filling material, such as gutta-percha
is then used to fill the remainder of the canal. A relatively hard
protective and restorative cover, such as amalgam, is then placed
at the access opening.
Over the next five or six months the human body will begin first,
to resolve the abcess formed at the exterior of the tooth root.
Additionally, the fresh blood supply will initially allow a blood
clot to form in the calcium phosphate compound. This will result in
the formation of a vascular supply which will supply cells which
mature and lay down a colagen-like matrix in the manner similar to
that described above with the pulp capping technique. Eventually,
an osteodentin barrier will be formed across the apex in a manner,
it is believed, similar to that described above with the pulp
capping procedure.
After an approximate five or six month period it is desirable to
remove the temporary filling and reinstrument the interior of the
tooth down to the hard, newly formed ostenodentin plug at the apex.
The interior of the tooth is cleaned and repacked with a dense,
filling material.
This second cleaning and repacking, after five to six months, is
done in order to assure that the soft tissue matrix within the
osteodentin plug at the apex will be removed, thus eliminating the
possibility of tissue differentiation into a cell type which could
cause internal resorption of the tooth. The root canal is now
filled and sealed, and then provided with a hard surface
restoration such as amalgam.
With other root canal procedures involving peridontal damage, some
sort of cushioning ligament is formed during "normal" healing of
the abcessed region between the tooth and the bone. However, the
observed cushioning ligament after such normal healing is merely a
dense, basket-like, fibrous network with no particular alignment of
its fibers.
With a normal natural tooth, the fibers of the peridontal ligament
begin near the crown portion of the tooth in a nearly vertical
orientation. As one descends along the root of the tooth the fibers
are found to be more and more oblique until finally at the apex of
the tooth the fibers are generally horizontally aligned. With this
orientation the peridontal ligament is able to effectively
withstand the type of forces encountered at the various positions
on the tooth. For example, the peridontal ligament near the upper
root portion of the tooth adjacent the crown, generally must
withstand lateral and shear forces, while the ligament at the base
of the tooth must withstand compressive forces.
However, with the ligament formed during normal healing without
treatment according to the present invention, the ligament often
has no particular orientation at the root apex and therefore does
not provide for proper distribution of forces. The remarkable
result observed with the present invention is that the peridontal
ligament is formed with naturally oriented fibers. Since peridontal
ligament tissue is laid down by fibroblasts, it appears that the
use of the described calcium phosphate compounds causes or enables
the growth of fibroblasts which have more naturally functioning
characteristics.
Cementum and bone are also formed. Therefore cementoblasts and
osteoblasts are also caused or enabled to be formed naturally by
the proper use of a calcium phosphate compound. In this manner the
treated tooth is held in a firm, solid foundation, permitting
normal function.
ROOT CANAL EXPERIMENTS
Four female cynalmolgus monkeys, ranging approximately from four to
six years of age were used as the experimental animals.
Twenty-Four root canals were used for study purposes. Maxillary and
mandibular cuspids and central incisors were selected because their
apices are widely spaced or separated by a suture line. Each apex
could be studied individually, without danger of introducing
additive or crossover effects from any other tooth used as either a
control or experimental tooth in the same animal.
Radiographs were taken at the following times:
1. prior to treatment;
2. with the endodontic file through the apex,
3. to determine the level of the gutta-percha just prior to
obturation, and
4. just after the animals death.
Anesthesia was induced with intravenous Sernylan and Pentobarbitol
Sodium. Atropine was employed to control salivation. Radiographs
were taken of the teeth to be used in the study, and the teeth
isolated, individually, under the rubber dam. Tooth surface
disinfection was accomplished with betadine. An access opening was
made through the lingual side of the crown and the pulp extripated
with barbed broaches. All canals were prepared through the apex
with 4 millimeters, up to the size No. 80 file, as determined from
a working length radiograph. The root canals were irrigated
frequently during instrumentation with 5 per cent sodium
hypochlorite. Upon completion of biomechanical preparation, each
canal was flushed with normal saline and dried with absorbent paper
points.
In twenty experimental teeth, a specially prepared form of
tricalcium phosphate was introduced into the canal and forced
gently through the apex, thus an attempt was made to fill any
defect created by the endodontic file with tricalcium phosphate.
The tricalcium phosphate was then removed from all but the apical 3
to 5 millimeters of the root canal. A gutta-percha cone was tried
and adjusted for tug-back to the level of the tricalcium phosphate
within the canal. Using Diaket as a sealer, the canals were
obturated with the fit gutta-percha cone, using the lateral
condensation technique. Lingual access was sealed with a silver
amalgam filling.
In each of the four monkeys one tooth was selected to act as a
control. In the control teeth NO tricalcium phosphate was used.
After biomechanical preparation had been completed a gutta-percha
cone was adjusted for tug-back at a level about four millimeters
short of the radiographic apex. Diaket sealer and lateral
condensation of the guttapercha were used to obturate the canals.
Lingual access was sealed with a silver amalgam filling.
At intervals of 2, 5, 16 and 24 weeks the animals were anesthetized
as before and sacrificed by perfusion with 10 per cent formalin
through the left ventrical. After 10 minutes of perfusion, the
mandible and maxilla were removed, stripped of soft tissue and
sectioned so one tooth remained in each block section. Individual
segments, appropriately labeled, were fixed an additional 7 days in
5 per cent buffered formalin solution. After fixation was complete
the individually labeled specimens were rinsed in tap water, and
spaced in five per cent formic acid for demineralization. The acid
was changed every day for approximately twenty-one days, at which
time chemical tests indicated that decalcification was complete.
Upon completion of the demineralization process all specimens were
embedded in paraplast and oriented, in the final paraplast block,
to yield labiolingual sections parallel to the long axis of the
tooth when sectioned on the micratome.
Six to eight micron, longitudinal sections, were obtained in serial
sections from all teeth. Every fifth section was stained with
hemotoxylin and eosin and examined under the light microscope. Each
specimen was evaluated for:
1. the degree of inflammation present in the periapical
tissues.
2. cementum, dentin, and bone resorption or deposition, and
3. replacement of the tricalcium phosphate material by osteoid,
osteo-dentin or osteocementum in the apical portion of the root
canal and surrounding bone.
In animal sacrifice between two weeks and six months, the degree of
inflammation about the apex was found to be very low. A blood clot
had formed in the tricalcium phosphate and vascularization did
occur. Absorption of the tricalcium phosphate had taken place with
a consequent deposition of a dentin type material within the root
of the tooth.
After the six month period, the dentin type material filled about
90% of the total circumference of the root canal leaving only a
very small opening. Peridontal ligament had not only formed but it
had reassumed its normal form and orientation and presumably its
function. Bone morphology appeared normal with no active resorption
of bone or tooth seen at any place in the teeth where tricalcium
phosphate had been used. There was therefore a very high
predictability of apical closure when tricalcium phosphate was used
according to the present invention.
In all of the control teeth, in which no materials were used, there
was some ingrowth of bone into the root canal observed but there
was no significant deposition of cementum of dentin on the walls of
the root canal. There was in fact, no apical closure and a moderate
to severe inflammatory response observed in 50% of the cases.
In prior studies using clacium hydroxide the degree of sucess
approached 70%. However, after a period of 1 to 4 years in perhaps
15 to 20% of the cases a breakdown is observed in the periapical
area resulting from leakage with eventual reinfection of the root
canal and surrounding periapical structures.
Although approximately 20 children and four or five adults have
been treated with the root canal procedure of the present
invention, insubstantial time has passed for an analysis of
results.
However, internal-external root resorption observed in humans has
been treated by similar procedures involving cleansing of the root
canal and packing it with tricalcium phosphate with a sufficient
force to attempt to extrude the tricalcium phosphate into the area
of external resorption. Observation of these cases show that the
external resorption appears to have stopped and a filling in of
hard material seems to be taking place.
TOOTH REPLANTING
It is known that approximately one quarter of all teeth which have
been traumatized, but not avulsed, subsequently undergo external
resorption. It is also observed that, unless teeth, which have been
completely dislodged, are replanted within approximately ten
minutes, the root is similarly resorbed and the tooth is eventually
lost.
Six such avulsed teeth in humans were replanted. Subsequently, root
canal procedures as described above were performed with tricalcium
phosphate being injected into the periapical regions. It has been
observed after six months that there is no evidence of external
resorption. Preferably however, a dry tricalcium phosphate powder
would be dusted onto the exterior root surfaces using, for example,
a particulate atomizer or sprayer prior to replanting of the
tooth.
It is of course known that bone, cementum and dentin are formed
from cells termed osteoblasts, cementoblasts and dentinoblasts
respectively. It is known that these same calcified materials are
resorbed by cells termed osteoclasts, cementoclasts, and
dentinoclasts. It also known that these "blasts" and "clasts" all
originate from cells known as osteosites, cementosites and
dentinosites.
It is therefore theorized by the inventors that the physiologically
compatible and soluble calcium phosphate compounds described above
appear to provide an environment conducive to the growth of blasts
and will stimulate the metamorphosis of clasts into sites to permit
the further differentiation into the necessary blasts.
It is to be understood that while the detailed drawings and
specific examples given, describe preferred embodiments of the
invention they are for the purposes of examples only, that the
method of the invention is not limited to the precise details and
conditions disclosed and that various changes may be made therein
without departing from the spirit of the invention which is defined
by the following claims.
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