Biocompatibility of Dental Materials: DR Khushboo R I Mds

Biocompatibility of dental
materials
Dr Khushboo R
I MDS
SCOPE
Introduction
Classification of biocompatibility tests
Various biocompatibility tests
Standards regulating the tests
Allergic reactions to dental materials
Pulp responses to operative materials
Periapical responses to endodontic
materials
Conclusion
INTRODUCTION
Biomaterial
is used to make devices to replace a part or
a function of the body in a safe,reliable,
economic, and physiologically acceptable
manner
[Hench and Erthridge, 1982]
The Clemson University Advisory Board for

Biomaterials -a systemically and
pharmacologically inert substance designed
for implantation within or incorporation with
living systems.
INTRODUCTION
The success of biomaterials in

the body depends on factors such
as the material properties,
design, and biocompatibility of
the material
INTRODUCTION
Increaseemphasis on biocompatibility
since the last quarter of 20th century..
Council on Dental Materials, Instruments

and Equipment of American Dental
Association (1972) published an article
entitled Recommended Standard
Practices for Biological Evaluation of
Dental Materials.
INTRODUCTION
Biocompatibility of materials is defined as the

ability of material to function in a specific
application in the presence of an appropriate host
response
Biocompatible is defined in Dorlands Illustrated

Medical Dictionary as being harmonious with life
and not having toxic or injurious effect on biologic
function
Propertyof the material to

be in harmonious relation
with the tissue..
INTRODUCTION
Interaction between the body tissues

& the foreign material.
Interface between the material & the

tooth pulp, dentin, periodontium,
periapical areas, oral cavity in
general
Dynamic relation
INTRODUCTION
Dental restorative material should-

Be harmless to the pulp and to the soft
tissues
Contain no toxic diffusible substances that
can be absorbed into circulatory system
to cause a systemic toxic response
Be free from sensitizing agents that could
lead to allergic response
Have no carcinogenic potential
Provide adequate marginal seal
CLASSIFICATION
According to Anusavice
Primary tests
Cytotoxicity tests
Genotoxicity tests
Secondary tests
Systemic toxicity
Inhalation toxicity
Skin irritation & sensitization
Implantation tests
CLASSIFICATION
Preclinical usage tests

Pulp & dentin usage tests
Pulp capping & pulpotomy usage tests
Endodontic usage tests
CLASSIFICATION
According to FDI
Initial tests
Oral test
Intraperitoneal tests
Inhalation tests
Haemolysis tests
Ames tests
Styles tests
Dominant lethal tests
Cytotoxicity tests
CLASSIFICATION
Secondary tests
Sub-cutaneous implantation tests
Bone implantation tests
Sterilization tests
Oral mucous membrane irritation tests
Usage tests
Pulp & dentin tests for restorative materials
Pulp capping & pulpotomy material tests
Endodontic material tests
Endosseous implant material test
CLASSIFICATION
According to William O Brien
Initial tests
Cytotoxicity tests
Mutagenesis tests
Immune function assay
Complement activation tests
Haemolysis tests
Oral & intraperitoneal Median Lethal
Dose assays
CLASSIFICATION
Secondary tests
Mucous membrane irritation tests
Skin sensitization tests
Implantation tests
Usage tests
Dentin pulp irritation tests
Dental implantations into bone
Mucous & gingival tests
BIOCOMPATIBILITY TESTS
Primary tests-
Economical, in vitro screening tests
product with promising attributes
subjected to secondary tests
Done outside a living organism
Placement of a material in direct or
indirect contact with a cell, enzyme or
other isolated biological system.
Direct tests are further sub-divided - the
material or some extract from the
material
Secondary tests
In vivo, animal tests
Distinct from the usage tests
Dental materials in contact with the
tissues of healthy laboratory animals
Several tests for checking allergy,
inflammations & other sub-lethal
chronic biological responses
Usage tests
Material placed in a situation identical to
its intended use
Conducted at last
Usefulness directly proportional to the
fidelity with which the test mimics the
clinical use of the material
Employs animals with similar oral
environment as humans
Drugs usage tests thoroughly
conducted & scrutinized.
Dental material manufacturer 7 yrs to
prove efficacy of the product
Should not be assumed that a dental
product that can be purchased
necessarily fulfills the advertized
claims
Look for ADA seal
Cytotoxicity Tests
Dental material in a fresh or a cured
state placed on tissue culture cells or
on membranes on culture cells
Assess the cytotoxicity by measuring
cell number or growth after exposure
Cells placed in a well of a cell cultured
dish
Materialnot cytotoxic-the cells remain
attached to the well & will proliferate
Material cytotoxic-the cells stop

growing, exhibit cytopathic features or
detach from the well
Material is solid- zone of inhibited cell

growth is assessed
Change in membrane permeability
also a test to measure cytotoxicity
Basis -loss in membrane permeability
is equivalent to cell death
Two types of dyes vital & non-vital
Vital dyes- Neutral red, Na2CrO4
Non vital dyes -Trypan blue, Propidium
iodide
Genotoxicity Tests
Ames test-
1. Histidine dependent mutants are
exposed to the sample & the rate of
reversion to non- histidine dependent
strains is noted
2. The chemicals that the frequency of
reversion back to the native state
have a high probability of being
carcinogenic
Styles cell transformation test
1. Assay quantifies the ability of
carcinogenicity of the material
2. Cell lines allowed to grow in soft agar
3. Untransformed fibroblasts do not
grow within an agar gel whereas
genetically transformed cells grows
below gel surface
Systemic toxicity
Oral median lethal dose (LD50) test
1. Test sample administered daily to
rats for 14 days
2. If 50% of the animals survive,
product considered non toxic.
Dermal Toxicity
Irritation- defined as an inflammation
brought about without the intervention
of an antibody or immune system
Sensitization- defined as an
inflammatory response requiring the
participation of an antiboby system
specifically for the material allergen in
question.
Allergen- it is defined as a
substance that is not primarily
irritating on the first exposure but
produces reaction more rapidly in
animals of appropriate genetic
constitution on subsequent
exposure to similar concentration
The test material is introduced
intradermally on the shaved
intrascapular region
After 24hrs- dermal reaction assessed
Forthe main test, the highest

concentration of the test material that
causes no more than slight erythema
& edema is selected
After7 days, same concentration test
material placed on the gauze patch &
applied to the previously injected sites
After removal of the dressing at 24hrs,

48hrs & 72hrs, the skin reaction at the
challenged skin sites evaluated &
graded
Mucous Membrane Irritation Test
Conducted by placing the test
material & positive & negative
controls in contact with tissue
After several weeks of contact, the
controls & test sites examined & the
gross tissue reaction recorded
Animals then sacrificed & biopsy
specimens prepared for histological
evaluation
Inhalation Toxicity Tests
Test performed on animals in an
exposure chamber by releasing the
spray material around the head and
upper trunk
Animals subjected to 30sec of
continuous spray released at 30min
interval
After 10 consecutive exposures,
animals observed over a 4-day period.
If the animal dies within 2-3 minutes,
the agent considered very toxic.
Implantation Tests
For materials that contacts sub-
cutaneous tissue or bone
Considers form, density and surface
finish of the product
Short term tests ( 12 weeks)-
material implanted in sub-cutaneous
tissue or muscles
Long term tests ( 12 weeks) in
muscles or bone
Short term implantation by aseptically
placing the compound in small open
ended polyethylene tubes into tissue
Test samples & controls placed at
separate sites & allowed to remain for
1-11 weeks.
Or an empty tube embedded first &
the inflammatory reaction from
surgery allowed to subside. The test
material placed thereafter.
Areas excised & prepared for
microscopic evaluation.
Bone implantation- the lateral cortex
of femur or tibia exposed, holes are
drilled & cylinders of the test material
implanted into drilled holes.
H/P- evaluate the formation of new
bone onto the surface of the test
implant material without intervening
connective tissue
Pulp & dentin usage test
Designed to assess the
biocompatibility of material in dentin
adjacent to pulp
Materials placed into class V cavity
preparation in monkeys
1mm or less of tubular dentin is left
between the floor of the cavity
preparation & the pulp
Negative control zinc oxide
Positive control a restorative material
(induces a moderate to severe pulp
response)
If a product is to be used as a luting
agent, a class V cavity preparation is cut
to receive inlays
Then luted under pressure till the initial
set of the luting agent to simulate
hydraulic forces produced during
cementation
Animals sacrificed after 7, 28,
70days
Teeth sectioned & evaluated
Necrotic & inflammatory responses

analyzed & the thickness of the
remaining & reparative dentin are
quantified
Promising test materials induce
the least inflammatory response
in the pulp
If response produced, the time

required to disappear is
measured
Less the reparative dentin, the

better
Pulp Capping & Pulpotomy usage tests
Pulp exposed for pulp capping and
partially removed for Pulpotomy
assessment
Ca(OH)2 used as a negative control
The animals sacrificed after 1, 7 &14 days
Quality & the structure of dentinal bridge
evaluated
Preferred to find a bridge directly against
the capping material
Endodontic usage tests
Pulp completely removed and
replaced by obturating test material
and control materials
Animal sacrificed after 28+/- 3 days,
13+/- weeks.
Teeth removed & degree of
inflammation evaluated
Biocompatible material- minimum/no
response/shortest resolution time
Dental implants into bone
3 evaluation criteria-
1. Penetration of a periodontal probe
along implant
2. Mobility of the implant
3. The bone implant integration
.Successful implant - no mobility, no
periimplant radiolucency, minimum
vertical bone loss, minimum fibrous
encapsulation & no soft tissue
complication
Mucosa & Gingiva tests

Materials are placed in cavity
preparation with subgingival
extensions
Materialseffect observed at 7
days & again after 30 days
Response categorized as slight,
moderate, severe
Difficultyis the presence of some degree

of pre-existing inflammation in gingiva
Perform dental prophylaxis
Time for healing (8-14 days) given before

assessing the effects
STANDARDS REGULATING THE
MEASUREMENT OF BIOCOMPATIBILITY
1926- 1st effort of the ADA to establish

guidelines for dental materials
Recommendation on materials not kept

pace with technological development
1. Fast advance in cellular & molecular
biology
2. Variety of tests for assessing
bioavailability
3. Lack of standardization
1933 (Dixon & Rickert) Toxicity
of dental material investigated by
implanting the material into
subdermal tissue
1959(Massler) implanted the test

material into pulp
1958 ( Mitchell) implanted the

test material into connective
1972- Council on dental material,
instruments & equipments
of ANSI/ADA approved
document no 41
1976- Passage of medical device bill
by congress for biological
testing for all medical devices
1982- Addendum made to the
previous document
ANSI/ADA document41
3 categories of tests described in 1982
ANSI document- initial, secondary &
usage tests
Initial tests- in vitro assays for
cytotoxicity, RBC membrane lysis,
Mutagenesis & Carcinogenesis at
cellular level & in vivo acute
physiological distress & death at
the level of whole organism
Secondary tests- in small animals for
inflammatory or
immunogenic
potential
Usage tests- placement of materials in
their intended use
Multinationalworking groups
formed to develop international
standard
Final document published in 1992
Standard divides tests into Initial

& Supplementary tests
Initialtests- tests for cytotoxicity,
sensitization, & systemic
toxicity. Some of in vitro,
others in animals in non- usage
manner
Supplementary tests- chronic
toxicity, carcinogenicity &
biodegradation. in animal
system, many in usage
situation
ALLERGIC RESPONSES TO DENTAL MATERIALS
Allergic Contact Dermatitis

Most common adverse reaction
Interval between exposure and the
occurrence of clinical feature varies
between 12-48 hrs
Usually occurs at direct contact site
Eg: - monomers of bonding agent,
acrylic components of
dental cements
Industry workers also affected
ALLERGIC RESPONSES TO DENTAL
MATERIALS
Allergy to latex products

March 29, 1991 FDA issued a bulletin
about the increasing number of latex-
related allergic reactions
Malten & associates (1976) reported
an increasing incidence of
hypersensitivity.
Thiuram, accelerators & antioxidants-

causative agent of latex allergies
InMarch (1998)- polyether, the

causative agent
Soaking the latex product gets the

allergen on the surface (Snyder &
Settle,1994)
Dermatitis of the hands (eczema)

Localized rashes and swelling to
wheezing and anaphylaxis
Most serious systemic allergies when
latex contact the mucous membranes
Vinyl gloves /other synthetic polymers
used
Allergic contact stomatitis

Most common adverse reaction to
dental materials
Reaction may be local (contact type
lesions) or distant from the material
site
Diagnostic test - patch test
MATERIALS
Patch test-
1. Allergen applied to the skin.
2. Takes 24-96hrs for the reaction to
appear
3. Causes hyperemia, edema, vesicle
formation & itchings ( Slavin &
Ducomb 1989)
.Dental materials contain many

components known to be allergens
MATERIALS
Baker & coworkers (1988)- self cure
appliances more allergic than heat cure
To avoid -appliances be immersed in

water for 24hrs before wearing
Patients found allergic to gold

restorations, amalgam & composite
Amalgam allergy mostly due to mercury

Mercury controversy
Controversy over biocompatibility of
amalgam restorations due to
elemental mercury
< 0.01% of ingested elemental
mercury is absorbed.
Has high vapour pressure
About 65-85% of the
mercury vapour that
is inhaled is retained
Symptoms of chronic Mercury

poisoning weakness, fatigue, anorexia,
weight loss, insomnia, irritability,
shyness, dizziness & tremors in the
extremities
Symptoms of Methyl Mercury

poisoning includes paresthesia of the
extremities, lips & tongue, ataxia &
concentric constriction of visual fields
Micromercurialism hypersensitivity
Patch test
The lowest level of total blood mercury

at which non-specific symptom occur
is 35 ng/mL
Allergy to nickel
10% of the female population
compared to about 1% of the male
population.
30% of patients with known nickel
allergy develop a reaction
Toxicity & allergenicity of beryllium

Berylliosis
Beryllium containing alloy ground with
adequate ventilation
MINIMIZING DENTAL IATROGENESIS
Iatrogenesis defined as the creation of

side effect, problems, or complications
resulting from treatment by a physician
or dentist
Stanley HR (1994) low speed hand piece

(6000-20,000 rpm) with air water spray,
a cavity preparation 2 mm from the pulp,
elicits minimal pulp lesion
Ifpreparation < 1 mm of the

pulp, intensity of response
increases
H/P thermal insult results in loss

of cytoplasmic continuity of
odontoblasts and displacement of
odontoblast nuclei into the
dentinal tubules due to
dehydration
Generation of heat- most severe

trauma to pulp
Extensive insult - cell rich zone of

pulp is damaged, reparative
dentin formation may be
impaired
The pulp is a tissue of low compliance

according to Goodies et al (1989)
Zach and Cohen (1965) reported

-15% of irreversible pulpal damage in
monkeys for a temperature elevated to
5.60C
-60% for a temperature elevated to 110C
-100% for a temperature elevated to
16.60C
In a cavity preparation, diamond bur

creates more heat than TC bur
According to Cohen, Blushing of
teeth during or after tooth preparation
attributed to frictional heat
Represents vascular stasis and is
reversible.
PULP RESPONSE TO SPECIFIC
AGENTS & TECHNIQUES
Amalgam
Conventional amalgam is considered
to be either inert or mildly irritating to
the
Low copper amalgam is well tolerated
than high copper
Inflammatory response
is seen after 3days
& after 5 weeks
AGENTS & TECHNIQUES
Swerdlow and Stanley (1962) blamed
condensation pressure for the pulp
response
Resolution as early as 15 days
Boremark and associates (1968)

showed that radioactive mercury
reached the pulp after 6 days if no
cavity liner was used
AGENTS & TECHNIQUES
Less transport of mercury in
older patients & in non vital teeth
Liners suggested to avoid pulpal

reaction
Gallium alloys showed a

significant foreign body reaction
than standard alloys
AGENTS & TECHNIQUES
Ahamad S. Al- Hiyasat, Omar M.
Bashabsheh, Homa Darmani (2003)
investigated the cytotoxicity of high noble
alloy and base metal alloys, including
nickel chromium alloys, cobalt chromium
alloys and copper based alloy using. It
was found that the high noble alloy was
least cytotoxic and copper based alloy
was the most cytotoxic followed by nickel
chromium and cobalt chromium alloys.
(International Journal of Prosthodontics 2003;
16(1): 8-12. )
AGENTS & TECHNIQUES
Chemically cured resin composite
If liner not used-chronic pulpitis lasts
for an indefinite time in ordinary depth
cavities
Increased potential for irritating the

pulp due to requirement of matrix
pressure to enhance adaptation to the
cavity walls
AGENTS & TECHNIQUES
Visible light cured resin composite

In vitro freshly set resin cause moderate
cytotoxicity
Newer systems cause minimal toxicity.
Inflammatory response low to moderate after
3 days when placed in cavities with 0.5mm
dentin.
Reactions diminished after 5-8 weeks
The cytotoxicity due to uncured resin
components
AGENTS & TECHNIQUES
Chemically cured composites more
cytotoxic than light cured composites
Prudent
to use twice the
recommended time exposure
Conservative cavity preparation with

incremental placement of the resin
composite highly recommended to
minimize the pulp response
AGENTS & TECHNIQUES
Zinc phosphate cement
Not toxic as base
For cementation, applied pressure in
seating the restoration causes flow of
acid, creating coronal pulp lesion after
3-4 days.
Young tooth more susceptible
Elicits strong to moderate
cytotoxic reactions that
decrease with time after setting
AGENTS & TECHNIQUES
Leaching of zinc ions and a low pH is
cause of these effects
Best protection-two coats of varnish,
dentin bonding agents or liner
Other formulations included calcium
hydroxide in the powder or copper &
fluoride as an antimicrobial
agent
AGENTS & TECHNIQUES
Polycarboxylate cements
Pulpal response similar to ZoE
Slightto moderate response after 3

days & only mild, chronic
inflammation after 5 weeks
Reparative dentin formation is minimal

& thus recommended only in cavities
with intact dentin
AGENTS & TECHNIQUES
Zinc oxide eugenol cements
Relatively innocuous in usage tests
Concentration of eugenol in the cavity
just below ZoE is10-2, the concentration
on the pulpal side is 10-4 or less
Causes slight to moderate
inflammatory reaction in first week
Mild, chronic inflammatory reaction with
reparative dentin formation within 5-8
weeks
AGENTS & TECHNIQUES
Calcium hydroxide cements
Initial response of exposed pulp tissue
is necrosis to a depth of 1mm or more
After necrosis, neutrofils accumulate
in the sub necrotic zone
After 5-8 weeks,mild to moderate
inflammation remains
AGENTS & TECHNIQUES
Resin mixed calcium hydroxide
becomes less irritating & stimulates
reparative bridge formation more
quickly with no zone of necrosis
Resin containing calcium hydroxide

are the most effective liners
Dycal better than pulpdent.

AGENTS & TECHNIQUES
Capping agent should never be placed
on a bleeding pulp
Can lift off the dressing and permit

formation of excessive clot resulting in
differentiation of fibroblasts and
odontoblasts to create ectopic
reparative dentin formation in non-
ideal site
AGENTS & TECHNIQUES
Glass ionomer cements

GIC pulpal response is bland,
moderate, less irritating than silicate
cement, zinc phosphate cement.
Attributed to absence of strong acids
of toxic monomers
Polyacrylic acid and polyacids are
much weaker than phosphoric acid
and possess higher molecular weight
AGENTS & TECHNIQUES
Tobias and other (1978), found that glass
ionomer cements are less irritating than
zinc phosphate cement, equivalent in
irritancy to polycarboxylate cement and
more irritating than zinc oxide cement
Smith and Ruse (1986) found a general rise
in pH for all cements during first 15 minutes
It is recommended that if there is less than
0.5-mm residual dentin or a pulp exposure,
an appropriate lining of calcium hydroxide
should be placed prior to the placement of
GIC
AGENTS & TECHNIQUES
Resin based composite cements (dual
cure)
Pameijir and Stanley (1992) reported that
when light not used, pulpal reactions
exceeded the acceptable biocompatible level
Important to use an adequate light curing

time
The increase in exposure to visible light is

not harmful to pulp tissue
AGENTS & TECHNIQUES
Peter E. Murray et al (2002) evaluated
and compared the pulp responses of zinc
oxide eugenol, calcium hydroxide, zinc
phosphate, resin modified GIC, composite
resin, bonded amalgam, gutta-percha,
compomers and silicate cements
Result the most effective restorative
material to prevent microleakage and
pulp injury from inflammatory activity
were resin modified GIC, zinc oxide
eugenol, bonded amalgam and
composite resin restoration
( Dental Material 2002; 18: 470-478)
AGENTS & TECHNIQUES
Conditioning agents
Brannstrom and Nordenvall (1977)
noted no significant difference
between dentinal surface conditioned
for 15 seconds and those conditioned
for 2sec
Controversy regarding presence of

smear layer
AGENTS & TECHNIQUES
Bowen and colleagues (1982) introduced
mordanting solution (acidified ferric oxalate)
Itdetected little pulp response due to

dentinal tubule closure
dentinis a very efficient buffer of protons &

most of the acid may never reach the pulp
dentinthickness of 0.5mm has proven

adequate
AGENTS & TECHNIQUES
Penetrationof acids in dentin is less than
100 microns
Possibility of adverse response cannot be

ruled
Conditioning techniques that are associated

with weaker acids, shorter periods of
application & the elimination of rubbing &
scrubbing procedures produce a minimal
pulp response & satisfactory bonding.
AGENTS & TECHNIQUES
Bonding agents
Between 1975-1992, studies showed
that bonding agents helped reduce
the pulp response induced by more
toxic resin based composites
Actsby plugging of
the dentinal tubules
AGENTS & TECHNIQUES
Unbound reagent caused the adverse
reaction
HEMA, a hydrophilic resin is atleast

100 times less toxic in tissue culture
than Bis-GMA
If the dentin in the floor of the cavity

is thin (less than 0.1mm), HEMA may
be cytotoxic
AGENTS & TECHNIQUES
F. M.Huang and Y. C. Chang (2002)
investigated the cytotoxicity of different dentin
bonding agent on human pulpal cells in vitro.
It was found that dentin bonding agents have
significant potential for pulpal toxicity and
toxicity is may be due to the leaching of
substances, like BIS-GMA,TEDMA, UDMA and
camphoroquinone from the dentin bonding
agents.
(International Endodontic Journal 2002; 35: 905-

909.18)
AGENTS & TECHNIQUES
Bleaching agents
Rapidly traverse the enamel & dentin
to be cytotoxic
Depends on a large extent to the
concentration of the peroxide used
Histologic or histochemical analysis of
the pulp following bleaching for upto 2
weeks showed minor reversible
inflammatory changes
(Anderson DG, Chiego DJ, Glickman gn, Mc
Cauley LK: a clinical assessment of the effects of
10% carbamide peroxide gel on human pulp
INFLUENCE OF PATIENT AGE ON
PULPAL RESPONSE
Older patients have less pulp tissue bulk
Reduced vascular component decrease the

capacity of the pulp to recover
Pulp has less defense in resolving a lesion

and resisting infection
Cliniciansshould make every effort to

minimize the development of pulp
responses
AGENTS & TECHNIQUES
Microleakage
Brannstrom and colleagues (1971, 1974)
have proposed marginal leakage around the
restoration, is a greater threat to the pulp
than is the toxicity of the restorative material
Materials lose their anti bacterial effects as

they cure and age
Microleakage causes the tooth to remain

sensitive following placement of restoration
AGENTS & TECHNIQUES
Severe leakage causes bacterial
growth between the restoration and
the cavity & into the dentinal tubules
Toxicproducts liberated by
microorganisms continuously irritates
the pulp
Initiatescaries around the margins of

the restoration
AGENTS & TECHNIQUES
Dentin hypersensitivity
Enormous out growth of dendrites
following injury contributes to
hypersensitivity
Around 21 days needed for complete

regeneration of the nerve ending
AGENTS & TECHNIQUES
If symptoms disappear (7-12
weeks), means sufficient reparative
dentin is formed
If symptoms persists, it is due to-
degradation of micromechanical
bond, shrinkage of resin during
polymerization, exposure of patent
dentinal tubules
Powell and colleagues (1990,
91)common in females
REACTIONS OF OTHER SOFT TISSUES
TO RESTORATIVE MATERIALS
Cements-
Exhibit some cytotoxicity in freshly mixed state
but decreases substantially with time
Composites
The cytotoxicity is from unpolymerized
componants
The toxicity of the aged composites decreases
with time
Newer composites with non- Bis-GMA, non- UDMA,
matrices have significantly lower toxicity
Polished composites show markedly less
cytotoxicity
Amalgam
When carried into gingiva, causes
inflammatory response
At30days, epithelial proliferation &

mononuclear cell infiltrate seen
Copper toxic to host cells
Severe reactions to gallium based alloys

Materials when continuously bathed in
saliva, cytotoxic agents washes away
before harming gingiva
Finished surface gives milder response
than unfinished margins
Casting alloys
Good record of biocompatibility
Clinically proven that patients with
palladium allergy, virtually allergic to
nickel but converse not true
BIOCOMPATIBILITY OF SEALERS
AH-26
In tissue culture studies, it gave
variable responses from being devoid
of cytotoxicity to moderate to severe
reactions
The animal studies revealed that AH-
26 produces an initial severe
inflammatory reaction, which
subsequently subsides
AH-26 is well tolerated by the

periapical tissues
Excessmaterial tends to become

encapsulated
AH-26 may cause mandibular

paresthesia following overfilling due to
its neurotoxic properties
Diaket
Use of Diaket in endodontics in
humans indicates that it is well
tolerated by the apical and periapical
tissues
Overfilling
with Diaket apparently
causes no inflammatory reactions and
was encapsulated by fibrous
connective tissue capsule.
Evaluated biocompatibility of 4 sealers-Zinc

Eugenol, Tubliseal, Sealapex and Endoflas.
They injected them into the subcutaneous
connective tissue of dorsal surface of rats.
They concluded all the sealers caused some
inflammation that decreased with time.
Overall, Sealapex showed least
inflammatory reaction compared with other
sealers.
M. Mittal, Satish Chandra and Shallen Chandra
Journal of Endodontics.Vol.21, No.12, 1995, 622-62
BIOCOMPATIBILITY OF
IRRIGATING SOLUTIONS
CHLORHEXIDINE GLUCONATE:
Possesses antimicrobial action,
substantivity, and relative absence of
toxicity
Chlorhexidine produced moderate
inflammation in the subcutaneous
tissues of guinea pigs after 2 days
followed by a foreign body granuloma
formation at 2 weeks
Various symptoms of immediate
hypersensitivity, have been reported
after topical treatment with
BIOCOMPATIBILITY OF
IRRIGATING SOLUTIONS
Sodium hypochloride
Tissue culture studies reported that 5%
sodium hypochlorite was extremely toxic to
cells
Undilutedand 1:10 dilution produced

moderate to severe irritation to rabbit eyes
Intradermal injection of undiluted, 1:2, 1:4,

and 1:10 dilutions of sodium hypochlorite
caused skin ulceration
BIOCOMPATIBILITY OF
INTRACANAL MEDICAMENT
Formocresol
Has immunogenic properties & act as an
irritant
Because of its vaporization, formocresol

haslong distance effects
Itwas found that when the formaldehyde

was radioactively tagged, the labeled
material was found in the dentin,
periodontal ligament, and alveolar bone.
BIOCOMPATIBILITY OF
Glutaraldehyde
When used as an endodontic irrigant,
a 2% glutaraldehyde solution has
been reported to produce little or no
periapical irritation, due to lack of
diffusion through dentin.
BIOCOMPATIBILITY OF
Mineral Trioxide Aggregate
Studies showed that in the freshly
mixed state MTA was found to be less
toxic than amalgam
With radiochromium method it was

found that mineral trioxide aggregate
to be the least cytotoxic.
BIOCOMPATIBILITY OF
OBTURATING MATERIAL
Gutta Percha
Gutta percha is relatively nontoxic,
although some cytotoxicity has been
reported
Few studies have found gutta percha

to be nonirritating to the apical tissues
BIOCOMPATIBILITY OF
OBTURATING MATERIAL
Gutta percha freshly dissolved in chloroform
or rosin chloroform is initially highly cytotoxic
Although the toxicity decreases after two

weeks
When gutta percha is pushed apically into

the periapical tissues,epithelium may
proliferate and grow around the excess
material. This may predispose to the
formation of radicular cyst.
BIOCOMPATIBILITY OF
OBTURATING MATERIAL
Hydron
The implants of this material in the
subcutaneous tissues and bones
of the experimental animals produces
moderate to severe inflammation
Overfillings with Hydron resulted in

calcification of the apical pulp and
periodontal ligament
CONCLUSION
Apart from physical, mechanical

properties biological properties plays
an important role .
The material also should be free of
agents that could elicit sensitization or
an allergic response in a sensitized
patie
BIBLIOGRAPHY
Science of dental materials- Anusavice
Dental materials & their selection-
William OBRIEN
Restorative dental materials- Craig
Materials in restorative dentistry-
Sherwood
Science of dental materials- Shama Bhat
Materials in restorative dentistry- A.
Parameshwaran
Biomaterials-principles & applications-
Joon B Park
Internet sources

Biocompatibility of Dental Materials: DR Khushboo R I Mds

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Biocompatibility of dental

The Clemson University Advisory Board for

The success of biomaterials in

Council on Dental Materials, Instruments

Biocompatibility of materials is defined as the

Biocompatible is defined in Dorlands Illustrated

Propertyof the material to

Interaction between the body tissues

Interface between the material & the

Dental restorative material should-

Preclinical usage tests

Material cytotoxic-the cells stop

Material is solid- zone of inhibited cell

After 24hrs- dermal reaction assessed

Forthe main test, the highest

After removal of the dressing at 24hrs,

Teeth sectioned & evaluated

Necrotic & inflammatory responses

If response produced, the time

Less the reparative dentin, the

Mucosa & Gingiva tests

Difficultyis the presence of some degree

Perform dental prophylaxis

Time for healing (8-14 days) given before

1926- 1st effort of the ADA to establish

Recommendation on materials not kept

1959(Massler) implanted the test

1958 ( Mitchell) implanted the

Final document published in 1992

Standard divides tests into Initial

Allergic Contact Dermatitis

Allergy to latex products

Thiuram, accelerators & antioxidants-

InMarch (1998)- polyether, the

Soaking the latex product gets the

Dermatitis of the hands (eczema)

Allergic contact stomatitis

.Dental materials contain many

To avoid -appliances be immersed in

Patients found allergic to gold

Amalgam allergy mostly due to mercury

Symptoms of chronic Mercury

Symptoms of Methyl Mercury

The lowest level of total blood mercury

ALLERGIC RESPONSES TO DENTAL MATERIALS

Toxicity & allergenicity of beryllium

Iatrogenesis defined as the creation of

Stanley HR (1994) low speed hand piece

Ifpreparation < 1 mm of the

H/P thermal insult results in loss

Generation of heat- most severe

Extensive insult - cell rich zone of

The pulp is a tissue of low compliance

Zach and Cohen (1965) reported

In a cavity preparation, diamond bur

Resolution as early as 15 days

Boremark and associates (1968)

Liners suggested to avoid pulpal

Gallium alloys showed a

Increased potential for irritating the

Visible light cured resin composite

Conservative cavity preparation with

Slightto moderate response after 3