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Because of the increasing concern of the ADA in the early 1960s for the safety
of biocompatibility of dental materials and devices, a committee was established in 196
to develop testing procedures generali!ed use"
#he document for these tests, $%ecommended &tandard 'ractices for Biological
(valuation of Dental )aterials* was published in 19+," #his was later revised and
republished in 19+9 as document no" -1"
A similar document was produced and published by the .D/ 0.ederation
Dentaire /nternationale1 in 192-"
3urrently, a new document is being developed to meet international needs" #he
draft document is entitled 4 $'re5clinical evaluation of biocompatibility of )edical services
used in dentistry 4 #est methods*"
#he term biocompatibility is defined in Dorlands /llustrated )edical Dictionary as
$being harmonious with life and not having to6ic or in7urious effects on biologic function"
/n general, biocompatibility is measured on the basis of locali!ed cytoto6icity
0such as pulp and mucosal response1
&ystemic responses"
Based on these criteria, the re8uirements for dental materials biocompatibility
include the following9
/t should not be harmful to the pulp and soft tissues"
/t should not contain to6ic diffusible substances that can be released and
absorbed into the circulatory system to cause a systemic to6ic response"
#he service of dental biomaterials must be based on a broad information base of
certain biologic considerations that are associated with the use of materials designed for
the oral cavity"
/n a broad sense, a biomaterial can be defined as $any substance, other than a
drug, that can be used for any period as a part of a system that treats, augments or
replaces any tissue, organ or function of the body*"
Dental materials are used in humans for short or long periods" )ost dental
materials are triangular to other speciali!ed materials used in orthopedics,
cardiovascular prosthesis, plastic surgery and opthalomology, that is, they function in
close contact with various human tissues"
3ollectively, these materials must meet the re8uirements give in the definitions
of the terms biomaterials, biocompatibility and bioacceptance"
:hen dentists purchase a material, they should ;now if it is safe and if it is safe,
how it is relative to other materials" Dental students should ;nown the most li;ely side
effects of materials, whether they affect dental patients or dental au6iliary personnel and
laboratory techni8ues"
Tests for Evaluatio of Bio!o"#ati$ilit%
#he purpose of biocompatibility test is to eliminate any potential product or
component of a product that can cause harm or damage to oral or ma6illofacial tissues"
Bio!o"#ati$ilit% tests are !lassifie& o t'ree levels (tiers)*
Grou# I Grou# II Grou# III
Pri"ar% tests Se!o&ar% tests Pre+!lii!al usa,e tests
<enoto6icity test &ystemic to6icity test
Dermal to6icity test
/nhalation to6icity test
/mplantation tests
'ulp and dentin usage tests
'ulp capping and pulpotomy
usage tests
(ndodontic usage test"
Grou# I - Pri"ar% Tests
3onsists of cytoto6ic evaluations"
=ere, dental materials in a fresh > a cured state are placed directly on
tissue culture cells ?% on membrane 0barriers such as dentin dis;s1 overlying
tissue culture cells that react to the effects of products or components that leach
through the barriers"
)any products that are 7udged initially to be 8uite cytoto6ic can be
modified or their use can be controlled by the manufacturer to prevent cyto6icity"
Geoto.i!it% Test * =ere, )ammalian > @on5mammalian cells, bacteria, yeasts, or fungi
are used to determine whether gene mutations, changes in chromosomal structure, or
other genetic changes are caused by the test materials, devices and e6tracts from
<roup // &econdary #ests 9 /n these tests, the product is evaluated, for its potential to
&ystemic to6icity"
/nhalation to6icity
&;in irritation and sensiti!ation
/mplantation responses
&ystemic to6icity test 4 ("g", oral median lethal dose 0ADB01 test, the test sample
is administered to daily to rats for 1- days either by oral gauge or by dietary inclusion"
/f B0C of the animals survive, the product has passed the test"
(fforts are being made to develop other systemic to6icity tests that re8uire for
fewer animals"
Der"al to.i!it% tests9 #hese tests are important because of the great number of
chemical substances, not only dental products, that we contact daily"
A primary irritant is capable of producing an inflammatory response in most
susceptible people after the 1
?nce, a to6ic material, product or component is identified, it can be replaced,
diluted, neutrali!ed, and chelated to reduce the ris; for to6icity"
/n addition, irritation and sensiti!ation must be differentiated"
Irritatio 4 is defined as an inflammation brought about without the intervention of an
antibody > immune system"
Sesiti/atio 4 is an inflammatory response re8uiring the participation of an antibody
system specific for material allergies in 8uestion"
#o simulate dermal to6icity, the test material is held in contact with the shared
s;in of albino rats for periods ranging from ,- 0one e6posure1 to 90 days 0with repeated
#he animal must receive an occlusive covering to prevent mechanical loss of the
contacting agent, even by evaporation"
#he guinea pig is the lab animal used to establish allergic contact sensiti!ation"
Aller,e 4 is defined as a substance that is not primarily irritating on the 1
e6posure but
produces reactions more rapidly in animals of appropriate genetic constitution on
subse8uent e6posure to similar concentrations"
#he test material is introduced interdermally on the shared intrascapular region"
After ,- hours, the resulting dermal reaction is assessed"
.or the main test, the highest concentration of the test material, that causes no
more than slight erythema and edema is selected"
After an interval of + days, the test material of the same concentration is
placed on gau!e patches and applied to cover the previously in7ected sites"
1- days later, the test material is applied to the shared flan; of the
After removal of the dressings at ,-, -2 and +, hours, the s;in reactions
at the challenged s;in sites are evaluated and graded"
0I'alatio to.i!it% tests
#he inhalation to6icity tests are performed on rats, rabbits, or guinea pigs on
e6posure chamber with aerosol preparations by releasing the spray material around the
head and upper trun; of the animals"
#he animals are sub7ected to 0 seconds of continuous spray released
at 0 minutes interval"
After 10 consecutive e6posures, the animals are observed over a -5day
period" /f any animal dies within ,5 minutes, the agent is considered very to6ic"
/f none of the animals die, the agent is not li;ely to be ha!ardous to humans
0&tanley 192B1"
0I"#latatio tests*
#he use of in vivo implantation techni8ues also ta;es into consideration the
physical characteristics of the product such as form, density, hardness and surface
finish, that can influence the character of the tissue response"
#he animal species is elected according to the si!e of the implant test specimen
and the intended duration of the test in relation to the life span of the animal"
.or short5term tests 0 1, wee;s1 in subcutaneous tissue or muscle, animals
such as mice, rats, hamsters, guinea pigs and rabbits are commonly used"
.or long5term tests 0 1, wee;s1 in muscle or bone, animals such as rabbits,
dogs, sheep, goats and subhuman primates with a relatively long life e6pectancy are
.or subcutaneous and muscle implanttion, the test implant material is pac;ed
into various types of plastic tubes 0variations of polyethylene or #eflon1"
.or bone implantation, the lateral corte6 of a femur or a tibia or both are
e6posed, and holes are drilled using low speed, intermittent cutting under profuse
irrigation with physiologic saline solution to prvent over5heating of the bone"
3ylinders of test implant material are inserted into the drilled holes by
finger pressure to allow a tight press fit"
#he diameter of the implant and the implant bed in the bone must match
well enough to avoid the ingrowth of fibrous connective tissue and mobility of the
=istopathologicaly, one evaluated the formation of new bone onto the
surface of the test implant material without intervening connective tissue"
0Grou# III * Pre+Clii!al Usa,e Tests*
A product can be approved by the D"&" food and Drug Administration 0.DA1 after
it successfully passes the primary and secondary tests on the bases that the product
should not be harmful to humans"
/n regard to dental materials, the manufacture has as long as + years to prove
efficacy after the product has reached the open mar;et with .DA approval"
0Pul# a& Deti Usa,e Test*
#his test is designed to assess the biocompatibility of dental materials placed in
dentin ad7acents to dental pulp"
@on5rodent mammals 0subhuman primates, dogs, furrets, and miniature pigs1
are selected to ensure that their dentition contains recently erupted, intact permanent
3lass E cavity preparation are cut on the buccal > labial surfaces or both
using sharp burs with an ade8uate air 4water spray to leave 1mm or less of
tubular dentin between the floor of the cavity preparation and the pulp"
#he appropriate number of cavities are restored"
As a negative control, some form of !inc5o6ide 0F?(1 is used"
.or a positive control, a restorative material is selected that consistently
induces a moderate to severe pulp response"
/f a product is to be used as a luting agent, a 3lass E cavity preparation is cut to
receive suitable inlays"
#hese are then heated under pressure for the length of time necessary to the
initial set of the luting agent to simulate the hydraulic forces produced during
cementation of full crowns, inlays or onlays"
#he animals are sacrificed after + days, ,2G days, +0GB days" After routine
histopathologic processing, the specimens are grinded for degree of inflammatory
response, the prevalence of reparative dentin formation in the pulp and the number of
microorganisms 0microlea;age1 entrapped in the surrounding cavity walls and cut
dentinal tubules"
'romising test materials induce the least inflammatory response in the pulp"
/f a response is produced, the time re8uired to disappear is also measured"
#he less reparative dentin that is subse8uently formed the bitter, because more
bul; vital pulp tissue is available to dent with future episodes of caries and dental
0Pul# !a##i, a& #ul#oto"% usa,e tests
=ere, the testing produces are same as those which were 7ust described, e6cept
that the pulp is merely e6posed for the pulp capping evaluation and is partially removed
for the pulpotomy assessment"
A 3a0?=1, product is used on negative control"
#he animals are sacrificed after +G, days and +0GB days observations
are made of dentinal bridge formation ad7acent to or sub7acent to the applied
capping material"
#he 8uality or structure of the covering dentinal bridge is determined"
/t is preferred to find a bridge directly against the capping material,
implying minimal destruction of pulp tissue at the same time the pulp capping
agent was applied"
0E&o&oti! Usa,e Test
.or this test the same types of animals are used but the pulp is completely >
almost completely removed from the pulp chamber and root canals replaced by the
obturating test material and control material"
F?( > F?( combined with a sealer 0usually <rossmans sealer1 is used
as a control material"
#he animals are sacrificed after ,2Gdays and 1G1 wee;s"
#he teeth are removed together with their surrounding apical periodontal
tissues 0soft and hard1 in a single bloc;"
#he degree of inflammation is evaluated in the periapical tissues"
.or a compatible material, one should observe minimal or no response
and the shortest resolution time if a response is detected" #his time is affected
by the resistance of the test material to degradation and dissolution"
:hen the latter occurs, tissue fluid accumulates in the porous areas of
the obturation material, and it may contribute to the growth of microorganisms,
recurrent infection and clinical failure"
0Aller,i! Cota!t Der"atitis as t'e "ost !o""o o!!u#atioal &isease1
#he interval between e6posure to the causative agent and the
occurrence of clinical manifestations usually varies between 1, and -2 hours,
although it may be as short as - hours or as long as +, hours"
#he incubation period may be as short as , days 0poisoning1 or as long
as several years 0for a wea; sensiti!er such as chromate1"
Dermatitis usually occurs where the body surface ma;es direct contact
with the allergen"
A s;in condition that is fre8uently confused with allergic contact dermatitis is
$primary irritant dermatitis*"
3aused by a simple chemical insult to the s;in ("g", $Dishpan hands*"
A prior sensiti!ing e6posure is not necessary
'rimary irritant dermatitis is dose dependent"
Allergic reactions are virtually dose dependent"
'ersonnel and patients involved in orthodontics and pediatric dentistry have the
highest incidence of side effects" 0B0C of the personnel 1C of the patients1"
An allergic contact dermatitis associated with the monomers of bonding
agents fre8uently involves the distal parts of the fingers and the palmar aspects
of the fingertips"
&imilar conditions can develop from acrylic components of dental
0Aller,% to Late. Pro&u!ts
?n )arch ,9, 1991, the .DA issued a bulletin 0D&, .DA, 19911 in response to
the increasing number of later related allergic reactions"
/n our modern environment there are many sources of daily late6 e6posure egs
li;e gloves, hot water bottles, rubber heating, rubber bul; eye droppers etc"
H=ypersensitivity to late65containing products may represent a true late6 allergy
or a reaction on to the accelerators and antio6idants used in late6 processing"
'rocessing brings the allergens to the surface and places the highest
concentration of allergens ne6t to the s;in of the wearer 0&nyder and &ettle, 199-1"
#he .DA 019911 has estimated about 65+C of surgical personnel may be allergic
to late6"
A survey of periodontists, hygienists, and dental assistants revealed that
-,C of these professionals reported adverse reactions to occupational
materials, most of which were related to dermatoses of the hands and fingers"
Adverse reactions in "+C of , patients were associated with late6
%eactions may vary from locali!ed rashes and swelling to more serious
li;e to whee!ing and anaphyla6is"
HDermatitis of the hands 0(c!ema1 is the most common adverse reaction
0%an;in et al 1991"
%epeated e6posure and duration of e6posure play a role in the degree of
response, which e6plains the high incidence of late6 allergy among surgical personnel"
#he most serious systemic allergic reactions occur when late65containing
products, such as gloves and rubber dam contact the mucous membrane"
H/n 192- Blin;horn and Aeggate described general angioneurotic edema, chest
pains and a rash on the nec; and chest of a 1B year old boy as a reaction to rubber dam"
0#he reported incidence of hypersensitivity reactions were almost e8ual to those
associated with gloves1"
#o avoid these adverse responses to late6 products, vinyl gloves or gloves made
from other synthetic polymers may be used"
0Aller,i! Cota!t Sto"atitis 4 is by for the most common adverse reaction to dental
%eactions may be local>contact type lesions, but reactions distant from the material
site 0e"g", itching on palms and feet and sole of feet1 are also reported"
H#he most definitive diagnostic test for allergic contact dermatitis > stomatitis is
the patch test"
#he suspected allergen is applied to the s;in with the intent to produce a small
area of allergic contact dermatitis"
#he test generally ta;es -2596 hours, although a reaction may appear
after ,- hours"
#he reaction may cause hyperemia, edema vesicle formation and itching
0&livin and Ducomb 19291"
Dental materials contain many components ;nown to be common allergens such
as chromium, cobalt, mercury, eugenol components of resin based materials,
colophonium and formaldehyde"
)inute amounts of formaldehyde may be released as a degradation
product of unreacted monomers in dentures made from resin based composite
materials" 'eople who are sensitive to formaldehyde may develop enhanced
tissue responses under this condition"
Ba;er and co5wor;ers 019921 demonstrated that the free residual methyl
methacrylate monomer in autopolymeri!ed acrylic dentures can also cause allergic
#he allergic reactions associated with resin5based materials affect not only
patients but also dental personnel wor;ing such materials"
%esin based composite materials consists of inorganic fillers usually
8uart! > glass and an organic matri6 composed of polymeric dimethyacrylates
0also initiators e"g", ben!ol pero6ide or comphor8uinone, accelerators, toludine,
anilines, inhibitor dibutyl pthalate"
#he polymeri!ation of composite materials is never complete i"e" a percentage of
reactive groups do not participate in polymeri!ation this incomplete polymeri!ation
may predispose to material degradation 4 this degradation and wear of the materials
release components of the resin based materials and these may cause reactions both
locally and systemically"
Although a few gingival reactions have been reported following contact with
composite materials, the permeability of the gingival epithelium enhances the penetration
of leachable components and thus the potential for to6ic and allergenic reactions"
Dnder e6tremely rare conditions 01"1 million1, patients who have been sensiti!ed
to gold may react to gold restorations with burning sensation and lichenoid lesions of the
oral mucosa in contact with gold alloy as well as generali!ed systemic reaction"
- &uch lichenoid reactions can also be seem with amalgam"
3hemicals that may produce allergic contact stomatitis on a short term basis can also
be found in mouthwashes, dentifrices and topical medications" ("g", Ao!enges and
cough drops #hese can cause burning, swelling and ulcerations of the oral tissues"
0T'e Mer!ur% Cotrovers%9 .or many years a contranged over the biocompatibility of
amalgam restorations because of elemental mercury"
:hen the most recent wave of antiamalgam sentiment the claim was made that
a few patients can react to e6treme amounts of mercury with signs and symptoms of
mercury poisoning"
/t was alleged that these patients had a condition that prompted some
dentists to diagnose this $micromercuralism hypersens through the use of
cutaneous patch test"
/n spite of attempts to demonstrate a direct relationship between the
presence of dental amalgams and deviated blood levels of mercury, nothing has
been found"
#he average mercury level in the blood of sub7ects with amalgam was
0"+mg>ml whereas the level in sub7ects without amalgams was 0"mg>ml"
/n comparison, other investigators reported that ingestion of one salt water
seafood meal per wee; raised the average blood level from ," to B"1mg>ml"
#hus, 1 salt water seafood meal > wee; can be e6pected to contribute +
times more mercury to blood levels than the presence of multiple dental
amalgam restorations"
#he lowest level of total blood mercury at which the earliest nonspecific
symptoms occur is B mg>ml 0after long5term e6posure1"
#hus, the widespread removal of amalgam is unwarranted"
&pray, a cavity preparation ,mm for the pulp elicits a minimal pulp lesion
despite restorations with F?("
As the cavity preparations approaches within 1mm of the pulp, the
intensity of the responses increases"
#he inflammatory response is significant in the first ,- hours9
@eutrophic migrates to deeper tissues of the pulp"
?dontoblasts are displaced into the dentinal tubules"
Aocal hemorrhages occur throughout the affected region"
But after a few days the initial lesion begins to reduce in a few days
0acute inflammatory cells are replaced by mononucleated cells1"
By around 0 days, reparative dentin will begin to form and reach its
ma6imum thic;ness after 60 days"
:hen a tooth preparation is cut at high speed 0B0,000rpm1 with ade8uate low5
pressure air5water spray and resotred with F?(, the pulp response is greatly reduced as
compared with low5speed techni8ues for preparations of comparable depth"
Pul# Res#oses to S#e!ifi! A,ets a& Te!'i2ues
A"al,a"9 conventional amalgam restorations have generally been considered to be
either inert or mildly irritating to the pulp"
A common histopathologic feature of amalgam5restored teeth is a dense
accumulation of neutrophilic leu;ocytes between the pre5dentin and the
odontoblast layer"
'ulp response to amalgam placement is related mainly to condensation
/f a practitioner places a conventional amalgam restoration after cutting
a cavity at high speed, the pressure of condensation will intensify the initial
minimal inflammatory response and it will subse8uently increase the formation of
reparative dentin"
&oremar; and associates 019621 showed that radioactive mercury
reached the pulp in humans after 6 days if no cavity liner was used"
#hey also found that the rate of diffusion of mercury into enamel and
dentin was inversely related to the degree of minerali!ation"
#his implies that in old patients, the penetration of mercury ions is less,
owing to the formation of sclerotic dentin"
0C'e"i!all% Cure& Resi Co"#osites
#hese filled resin composites, if not properly lined cause chronic pulpitis
that persists for an indefinite time even in cavities of ordinary depth 0dentin
thic;ness of appro6imate 1mm1"
#he responses to composite restorations may ta;e several days to
wee;s to develop a massive pulp lesion"
0Visi$le Li,'t+!ure& Resi Co"#osites
3omplete polymeri!ation of the entire composite restoration is important
to minimi!e pulp responses"
:hen a composite resin is incompletely cured in a deep cavity
preparation then the level of pulpal response is intensified"
Because incomplete curing of the resins permit high concentration of residual
unpolymeri!ed monomer to reach the pulp"
#he visible > ultraviolet lamps that are used for curing do not have
sufficient energy to cure a large volume or thic;ness in one application, it must
be cured in incremental layers"
<enerally, an increase in the si!e of a tooth preparation and the mass of
the restoration are associated with greater shrin;age of the restoration"
Eolumetric shrin;age accompanying the polymeri!ation reaction is still
the overwhelming obstacle in maintaining adhesion and minimi!ing
=ence, a more conservative cavity preparation with incremental placement of
the resin composite is highly recommended for posterior restorations"
03i! P'os#'ate Ce"et
:hen used as a base, !inc phosphate cement is not a highly to6ic
=owever, with cementation procedures, a different situation occurs when
a thin mi6 of !inc phosphate cement is used to cement a crown or inlay, a
stri;ingly different response occurs"
:hen the patient bites down on a tongue blade to seat the restoration,
the phosphoric acid within the mi6 of !inc phosphate cement is forced into
dentinal tubules"
After > - days, a widespread 5dimensional lesion involving all the
coronal pulp occurs"
A young tooth with wide open dentinal tubules is more susceptible to
such an inflammatory response than is an older tooth, which has produced a
considerable amount of sclerotic and reparative dentin that bloc;s the tubules
and prevents acids from reaching the pulp"
#he best protection against phosphoric acid penetration is provided by
cooling the dentin with , coats of an appropriate varnish, dentin bonding agent,
liner, or a thin wash of 3="
3= cements mechanically plug dentinal tubules and neutrali!e acids"
=ydrophilic resin primers may be used to set tubules and infiltrate the collagen
mesh produced by acid etching the dentin"
0Glass Ioo"er Ce"et
:hen </3 was first introduced as a restorative material the pulp responses were
classified as bland, moderate and less irritating than silicate cement and !inc phosphate
#he blandness of the </3 was attributed to the absence of strong acids
and to6ic monomer"
'olyacrylic acids and related polyacids are much wea;er than
phosphoric acid"
As polymers, they possess higher molecular weight that may limit their
diffusion through the dentinal tubules to the pulp"
&ome water5hardening 0water setting1 formulations, li;e ;etac5fil consists of dried
polymaleic acid produce instead of polyacrylic acid, with an a8ueous solution of tartaric
acid that supposedly leaves little or no unreacted anhydrons polymaliec acid"
&mith and %use 019261 compared the initial acidity of </3 with !inc polycarbo6ylate and
!inc phosphate cements and found a general rise in p= for all cements during the first 1B
#he li8uids in !inc polycarbo6ylate and phosphate cements reacted
rapidly with the powder, causing the p= to rise above ,"0 after 1minute of
#he initial reactions of </3 were slower, e6hibiting a p= of ,"0 at B
minutes and p= of "0 after 10 minutes"
</3s when used as luting agents appear to be pulp irritants because it was
recommended to apply a small dab of 3= only to areas of e6tensive crown preparations
whenever any site of preparation was believed to be within 1mm of the pulp before the
cementation procedure was carried out"
#his provided the re8uired pulp protection without decreasing the overall
adhesion benefits of the </3"
0Resi Base& Co"#osite Ce"ets (Dual+Cure)
:hen dealing with dual cure types of resin cement, it is important to use an
ade8uate light curing time" /f the time is ade8uate, the self5cure mechanism may not be
effective complete polymeri!ation of the remaining uncured resin that was light cured"
(6cessive pulp responses may then occur"
#he increase in e6posure time to visible light is not harmful to pulp
#he same physiologic laws that e6plain the to6icity of !inc phosphate cement
also apply to </3s"
)ore acid solution and less powder in the mi6ture increases the
probability of acid diffusion within dentin"
/n addition, an increase in conditioning time and hydraulic pressure
increases the severity of pulp responses"
03i! O.i&e Eu,eol Ce"et
#hese cements are least in7urious to the dental pulp" @ot only there is no
irritation produced by the material but actually is e6erts a mild palliative and
sedative effect on the pulp"
/t is such a bland material, that it may even lac; necessary irritating
products to stimulate the formation of ,I dentin"
0Co&itioi, (Et!'i,) A,ets
3onditioning agents are used with both resin composite systems and
:hen etching agents were first introduced high concentrations of
enamel etching acids 0+C and B0C phosphoric acid1 were used"
=owever, these high acid concentrations, when applied for e6tended
intervals, remove the smear unit 0the smear layer and dentinal tubule plugs1
thereby increasing the potential for severe pulp responses to restorative
materials placed subse8uently"
BrJnnstorm 019211 showed that conditioning of dentin and removal of smear layer unit
allows the ingress of bacteria and the outward flow of dentinal fluid within tooth material
interfacial region and possibly contributes to formation of a biofilm that interfere with
3onse8uently, some scientists recommend that the smear layer should
remain, but in a modified form"
But others propose that the smear layer be completely removed to
optimi!e the bonding of restorative materials for dentin"
)ount 019901 reported that the agent that removes the smear layer in B seconds
can cause considerable deminerali!ation if left in place for 0 seconds" /f left for 60
seconds can cause pulp damage"
%emoval of the smear layer was accomplished in B510 seconds of
e6posure for a wea; acid and in B seconds for a strong acid such as +C
phosphoric acid"
Bowmen and colleagues 0192,1 introduced a mordanting study 0acidified
ferric o6alate, subse8uently replaced by aluminium o6alate1 that appeared to
dissolve the original smear layer and replace it with a more uniform $artificial*
0altered smear layer1"
Eery little pulp responses were detected because of the dentinal tubule
closure produced by the creation of the new artificial smear layer"
#hus, studies suggest that only the surface of the dentin 010Km depth1 needs to
be modified and not its deeper layers"
H3onditioning techni8ues that are associated with wea;er acids, shorter periods
of application and the elimination of rubbing and scrubbing procedure produce a minimal
pulp response and satisfactory bonding"
0Bo&i, A,ets
Bonding agents do not appear to be to6ic" Betroy 19+B and 199, some studies
demonstrated that bonding agents helped reduce the e6pected pulp responses induced
by the subse8uent placement of more to6ic resin5based composite materials"
#o enhance bonding to a resin5based composite, fast setting EA3, low
viscosity 0unfilled1 resin primer is applied that infiltrates the deminerali!ed dentin
surface 0smear layer and tubules1 and the e6posed collagen mesh to form a
hybrid layer"
?n this layer, a bonding resin is placed and cured"
#he plugging of the dentinal tubules prevents the penetration of to6ic
components to the pulp from subse8uently placed resin5based composite restorations"
/n 1991, 'amei7er and &tanley evaluated 'risma Dniversal Bond 4 , 0'DB5,1 a ,
component, system composed of a dentin primer and an adhesive"
'rimer contained 0C by wt =()A, 6-wtC (thanol and '(@#A
0adhesive promotor1 6wtC 0Dispent5 acerythriotol 'enta5acrylate phosphoric1"
#he primer promotes wettability of the surface, it did not remove the
smear layer, but modified it by increasing its permeability, thus providing micro5
mechanical bonding"
#he adhesive co5polymeri!ed chemically with the primer" #hen the
primer was placed into 3lass E cavity preparations after having etched the
e6ternal border of the cavities"
#he adhesive was then placed and allowed to dry for 10 seconds"
'rismafil composite was then placed in the cavity and light cured for -0
&pecimens from subhuman primates revealed low5to5average
inflammatory cellular response values for all time intervals, despite small to
average %D# values"
HBrJnnstrom and colleagues 019+1, 19+-1 have proposed that infection caused by
penetration of microorganisms from marginal lea;age around the restoration and
especially beneath it, is a greater threat to the pulp than is the to6icity of the restoration
&tudies have shown that if lea;age is more , bacterial growth occurs
between the restoration and the cavity wall and e6tends up to the dentinal
/t has been concluded that the to6ic products liberated by such
microorganisms might produce continuing irritation to the pulp"
H@ordenvall and colleagues 019+91 predicted that if one microorganism was left in the
smear layer, more than 100 billion organisms could develop within ,- hours if the
conditions were favourable"
HBergonholt! 0192,1 pointed out that although micro5organisms may contribute to the
pulp responses beneath restorations, they appear to be unable to sustain a long5
standing irritation to the pulp"
HDnless recurrent caries develops under a clinically defective restorations the dentin
permeability to no6ious bacterial agents decreases over time even under continual
bacterial provocation, allowing the pulp to heal"
#his may e6plain why pulps remain vital in most restored teeth"
Although it is doubtful that marginal lea;age will ever be completely eliminated, it
certainly can be controlled" :hen e6tensive lea;age is associated with a clinically
defective restoration, recurrent caries can occur"
=owever, further research is need to identify the specific effects of microbial
activity associated with microlea;age"
0T'e O!!urre!e of Deti 5%#ersesitivit%*
&everal factors may be responsible for dentin hypersensitivity9
1" Age and se6 of the patient"
," #he age of the tooth"
" #he amount of sclerosis present"
-" #he pro6imity to the pulp 0%D#1"
B" #he presence or absence of 3= liners"
6" #he depth of the carious lesions versus the thic;ness of reparative dentin
/f no post5operative symptoms occur initially, one might assume that the bonding
and the micromechanical bond are intact and that there is no active lea;age"
=owever, the absence of symptoms may be attributed to sclerosis,
reparative dentin and sufficient %D# present to prevent symptoms although the
micromechanical bond may be degrading and microlea;age may be occurring"
/f the nerve endings in the superficial pulp tissues are in7ured by a
restorative procedure, the healing process induces an enormous outgrowth of
dendrites that temporarily contributes to increased dentin hypersensitivity"
Appro6imate ,1 days are re8uired for complete regeneration of the
nerve endings and return to a normal level of dentin sensitivity"
/f the symptoms develop over a longer period and persist, then it is reasonable
to consider factors such as9
1" Degradation of micromechanical bond"
," &hrin;age of resin during polymeri!ation and failure of liner > base"
" (6posure of patent dentinal tubules"
-" 3usp deformation"
B" (6cessive occlusal loading"
6" .le6ing during chewing 0because of low elastic modulus1"
+" #hermal stimulation"
#he potential for post5operative sensitivity is reduced or avoided by using
bonding systems that seal dentinal tubules"
0Pul# !a##i,
Cal!iu" '%&ro.i&e 9 3alcium hydro6ide in the pure state actually ;ills a certain amount
of tissue when placed in direct contact with the pulp rather than functioning as a bridge
@umerous studies have also shown that 3= is e6tremely to6ic to cells in
tissue culture"
#his destructive characteristic has spurred on a great effort to find a
formula that stimulates reparative dentin bridging without sacrificing any of the
remaining pulp tissue by chemical cauteri!ation, as occurs with many 3=
#he e6act mesh by which 3= generates a dentinal bridge is not clear"
/ts caustic action associated with high p= and its induction of superficial necrosis
are assumed to be the factors involved in the stimulation of ,I dentin formation"
05istolo,i! of 5eali, After Pul# Ca##i,
, different modes of healing have been proposed"
a1 Dentin bridge formation resulting from
original 3= production of high p= 011511
b1 =eal leading to dentin bridge formation
from a less al;aline 3= products"
:ith a cement li;e pulpdent 03= and =,?1, bridge formation occurs at the
7unction of the firm, necrotic non5vital layer created by the caustic 0high al;aline p=1 3=
agent that destroys 1mm or more of pulp tissue"
#his bridge can be readily visuali!ed with the radiolucent pulpdent paste
because the degenerated, necrotic !one separate the 3= layer from the bridge"
:ith the Dycal material, the calcified dentinal bridge forms directly
against the 3= 0the pulp capping agents1 and is more difficult to observe
H&tanley and Aundy 019+,1 found that Dycal produced the !one of coagulated
necrosis similar to that produced by 3= and water > pulpdent but that it was rapidly
removed by phagocytes and replaced with granulation tissue that 8uic;ly organi!ed
differentiated odontoblasts to produce dentin bridge ad7acent to the Dycal"
:ith some new hard setting formulations, bridging at the pulp inteface
occurs without the formation of a visible coagulated necrotic layer 0 indicates a
less e6tensive chemical in7ury than that produced by capping agents of high p=1"
=ealing and regeneration occur directly against the 3= dressing"
HA capping agent should never be placed on a bleeding pulp" /t is also important
to control any e6cessive oo!ing of serum or plasma because it creates a space by lifting
the pulp capping agent from the pulp tissue"
#his can lend to the formation of a clot which can get infected 0,I
infection1 leads to complete loss of pulp vitality"
0E&o&oti! Pro!e&ures
As a conse8uence of pathologic changes in the dental pulp, root canal system
can harbor numerous irritants"
%emoval of irritants from the root canal system and its total obturation
result in repair of periradicular tissue to its normal architecture"
0Sealer Effi!a!%
All currently available sealers lea;, and they are not impermeable"
#his lea;age may occur at the interface of the dentin and sealer, at the
interface of the solid core and sealer, through the sealer itself or by dissolution of
the sealer"
/f the lea;age is more, it can lead to endodontic failure"
&ome cements lea; more than others, mostly through dissolution"
#he border the sealer5periradicular tissue interface, the faster the
dissolution well ta;e place"
.ortunately, most of the root canal sealers currently used, as well as the
solid5core filling materials, are eventually tolerated by the periradicular tissue
once the cements have set"
/f the apical orifice can be bloc;ed principally by a solid5core material, success is
immeasurably improved over time" ?n the other hand, in most studies in which
obturation without sealers was attempted, the lea;age results were enormously greater"
#hus, sealers are essential for endodontic therapy to be successful"
0A#i!al filli, 6it' Deti !'i#s
Dentin chips may produce an apical plug against which other materials are then
/nstead of the routinely obtained mechanical5chemical seal, an apical plug can
be achieved as a $biologic seal*"
&uch a $plug* can prevent overfilling and can restrict the irrigating solutions and
obturating materials to the canal spaces"
After the canals is totally debrided and shaped, a drill or file is used to produce
dentin powder in the central position of the canal"
#hese dentin chips may then be pushed apically and pac;ed into place"
#o conclude, it is imperative for a dentist purchasing a material to ;now if the
material is safe and if it is safe, how safe it is relative to other material"
Dentists, dental students should ;now the most li;ely side effects of materials,
whether they affect dental patients or the au6iliary personnel and lab technicians" #hey
should also invariably recogni!e mechanisms through which these effects are produced
and efforts should be made to minimi!e it"