Biocompatibility of Dental Materials
Biocompatibility of Dental Materials
Biocompatibility of Dental Materials
MATERIALS
DR JEEVAN
CONTENTS
Introduction
Definition
History
Measuring biocompatibility
Biocompatibility tests
Invitro test
Cytotoxicity test
Mutagenesis assays
Animal test
• Mucous membrane irritation test
• Skin sensitization test
• Implantation test
Usage test
Dental pulp irritation test
Dental implants into bone
Mucosa and gingival usage tests
Summary
Conclusion
References
What is BIOCOMPATIBILITY?
Hippocrates (460-377 BC) the idea that new dental materials must be tested for safety and
As late as the mid 1800s,dentists tried new materials for the first time by putting them into
patients' mouths.
Many exotic formulations were used. For example, Fox developed a "fusible
metal“ that consisted of bismuth, lead and tin which he melted and poured into
Even G.V. Black used patients to test many of his new ideas for restorative
way evolved in the 1960s as the need to protect patients became politically acute and as the
The concept of protecting the patient as a research subject is only 30 to 40 years old.
Also, many of the regulations and ethics in this area are still being challenged and defined
today.
MEASURING THE BIOCOMPATIBILITY:
The initial tests (phases i and ii) are of a short duration, simple and cost
effective.
Only after completing initial test, the material progresses from simpler in
vitro tests to the more complicated in vivo tests.
Outside body
Quick, inexpensive, easy, standardized & well suited for large scale screening
• Disadvantage
Questionable relevance to final in-vivo study on same material & lack of inflammatory and
51Cr
NR
NR
TB
HEALTHY CELL TB INJURED CELL
2.CELL METABOLISM / CELL FUNCTION TESTS
It is a colorimetric assays
No direct contact
c. Sample material
Monolayer – gel is detached & turned upside down so that filter is on top for
placement of sample material
INFERENCE: if sample is cytotoxic, width of cytotoxic zone is assessed.
a) Immune function
c) Chemotaxis
d) Complement activation
a) Genotoxic mutagens : directly alter DNA of cell. Each chemical has specific DNA
b) Epigenetic mutagens : support tumor growth by altering the cell`s biochemistry. Do not
standardized cell
Usually involving mammals such as mice, rats, hamsters, or guinea pigs, and are
distinct from usage tests in that the material is not placed in the animal with
regard to its final use.
Advantage :
• The biological responses in animal tests are more comprehensive and may be more
relevant than in vitro tests
Disadvantages :
• there can be difficulties to interpret and control, are expensive, may be time consuming,
and often involve significant ethical concerns and paperwork.
1)MUCOUS MEMBRANE IRRITATION TEST
Place the test material , positive & negative control in contact with hamster cheek
Animals are then sacrificed & biopsy specimen are prepared for histological examination.
redness).
3)IMPLANTATION TESTS :
or histochemical methods
USAGE TESTS
GOLD STANDARD OF TESTS.
Disadvantages
These tests are extremely expensive, last for long periods, involve many ethical and
often legal concerns, and are exceptionally difficult to control and interpret
accurately.
1)DENTAL PULP IRRITATION TESTS :
INFERENCE: teeth removed & sectioned for microscopic examination shows necrotic &
inflammatory reactions of pulp.
Types of pulpal response:
odontoblastic zone
of odontoblastic zone.
implant
Failure of implant was denoted by formation of wall of a cyst around the implant caused
b. Moderate
c. Severe
Perform oral prophylaxis before the test as bacterial plaque initiate inflammation in gingiva
that may hinder the response.
CORRELATION OF TESTS
Each type of test are designed to measure different aspects of biological response to
materials
a material.
All materials were tested at the bottom of the pyramid & materials were webbed out
Progress of
testing
•Number of materials tested is represented by width of the triangle.
CLINICAL TRIALS •Unspecific toxicity :condition that did not necessarily reflect those of
UNSPECIFIC TOXICITY
No. of tests
CONTEMPORARY STRATEGY
Progress of
testing
•The concept was similar to early scheme except types of tests were
mutagenicity.
•Only material that passed the first tier of tests were graduated to
PRIMARY
second tier , & only those that passed second tier were graduated to
clinical trial.
No.of tests
FUTURE SRTATEGIES
All three test done initially, but as testing progresses, usage test predominates. Primary &
secondary tests play a continuing but a decreased role as test continues
The most common progression is from primary to secondary to usage test.
ANSI/ADA specification 41
This was approved by the council on scientific affairs in 1972 and was updated in 1982 to
include tests for mutagenicity.
This specification uses the linear paradigm for materials screening and divides testing into
initial, secondary, and usage tests.
ISO 10993
ISO 10993- It is the international standards for testing the biocompatibility of dental
materials.
Unlike ANSI/ADA document no. 41, the IS0 10993 standard is not restricted to dental
materials.
The standard divides tests into initial and supplementary tests to assess the biological
reaction to materials.
Reactions of pulp
MICROLEAKAGE
There is evidence that restorative materials may not bond to enamel or dentin
If a bond does not form, or debonding occurs, bacteria, food debris, or saliva
may be drawn into the gap between the restoration and the tooth by capillary
Smear layer S
The light-cured resins are less cytotoxic than chemically cured systems
The pulpal inflammatory response to chemically cured and light-cured resin
composites is low to moderate after 3 days when they were placed in cavities with
approximately 0.5 mm of remaining dentin.
Composite resins are cytotoxic in in-vitro tests of direct contact with
fibroblasts
Probably because of unpolymerized components in the air-inhibited
layer that leach out from the materials.
Some of the newer composites with non- BisGMA non-UDMA matrices
have significantly lower cytotoxicity
Polished composites show markedly less cytotoxicity in vitro.
bis-phenol-A and bis-phenol-A dimethacrylate to cause estrogen-like responses in vitro.
Even after 7 days after placing an amalgam, a few inflammatory cells appear
in the gingival connective tissue, and hydropic degeneration of some epithelial
cells may be seen
Amalgam
Histological studies in usage test shows that any inflammatory infiltrate to GIC is
minimal or absent after 1 month
There have been several reports of pulpal hyperalgesia for short periods (days) after
placing glass ionomers in cervical cavities.
This effect is probably the result of increased dentin permeability after acid etching
or the high pH of the restoration.
LINERS, VARNISHES, AND NONRESIN
CEMENTS
CALCIUM HYDROXIDE
ZINC PHOSPHATE
ZOE CEMENT
CALCIUM HYDROXIDE CEMENT
ZINC PHOSPHATE CEMENT
Zinc phosphate cement that was left in
the sulcus after cementation results in
periodontal destruction and bone loss
ZINC POLYCARBOXYLATE CEMENT
Polycarboxylate cements evoke a pulpal response similar to that caused by ZOE,
with a slight-to-moderate response after 3 days and only mild, chronic
inflammation after 5 weeks.
Reparative dentin formation is minimal with these cements, and thus they are
recommended only in cavities with intact dentin in the floors of the cavity
preparations.
ZINC OXIDE EUGENOL CEMENT
mice
PRECAUTIONS DURING
CEMENTATION
Apply petroleum jelly to the surrounding soft tissues
Any residues of cement left in the gingival sulcus will lead to inflammation
DENTAL CERAMICS
Bleaching agents
These agents usually contain some form of peroxide (generally carbamide
peroxide) in a gel that can be applied to the teeth either by the dentist or at home
by the patient.
The agents may be in contact with teeth for several minutes to several hours
depending on the formulation of the material.
Home bleaching agents may be applied for weeks to even months in some cases
In vitro studies have shown that peroxides can rapidly (within minutes) traverse
the dentin in sufficient concentrations to be cytotoxic.
Peroxides rapidly even penetrate intact enamel and reach the pulp in a few
minutes.
Contact with the eyes, which may happen when mixing a liquid catalyst
into a putty impression material by hand, should also be avoided, such
as by wearing protective glasses or by using a paste catalyst.
Extremely cytotoxic
This clinical report raises the possibility that in rare circumstances, for some
patients, the use of titanium dental implants may induce an allergic reaction.
Facial eczema Ten months after removal of
dental implants
a b