Biocompatibility of Dental Materials

Biocompatibility of Dental
Materials
Introduction
• Dentistry as a profession is 2000 yrs old.
• Use of dental materials is as old as the
profession.
• Around 2000 different materials are used
in dentistry currently.
• Not even one material is safe for 100% of
population.
Definition
Biocompatible is defined as being harmonious
with life and not having toxic or injurious effects
on biologic function.
Biomaterial is 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.
Requirements of dental materials
biocompatibility
• It should not be harmful to the pulp and soft
tissues.
• It should not contain toxic diffusible substances
that can be released and absorbed into the
circulatory system to cause a systemic toxic
response.
• It should be free of potentially sensitizing agents
that are likely to cause a systemic toxic
response.
• It should not have carcinogenic potential.
Area of concern
Oral environment is complex and varied
• Time
• Exposure
• Contamination
• Temperature
• pH
• Varied tissues and their response.
Allergy
• Type I – Anaphylactic Reaction
• Type II – Cytotoxic Hypersensitivity
• Type III – Immune Complex Hypersensitivity
• Type IV – Delayed Hypersensitivity
• Type V – Stimulating Antibody Reaction
• Type VI – Antibody Dependent, Cell Mediated
Cytotoxicity Reaction.bggf
Dentists role
• Should know about the safety of the
material purchased.
• Should know the side effects of materials,
whether they affect the patients, dentist, or
the technicians.
• Should know the mechanism by which
these effects are produced.
• Should know the means to prevent it.
Adverse Effects
• Toxicity
• Inflammation
• Allergy
• Mutagenicity
Biocompatiblity Tests
Purpose of these tests is to eliminate any
potential product or component of a
product that can cause harm or damage to
oral tissues or to the body.
Three levels of tests
Primary test
Secondary test
Preclinical usage test.
Primary test
Cytotoxic evaluation
Genotoxicity test
Secondary test
Material is evaluated for its potential to
create
• Systemic toxicity
• Inhalation toxicity
• Skin irritation and sensitization
• Implantation responses.
Secondary tests
Systemic toxicity test – Sample is administered for
14 days to rats thru diet.If 50% of animals
survive, the product has passed the test.
Dermal toxicity test – Sample is held in contact
with the shaved skin of albino rats for 24 to 90
days.
Sensitization test – Done on guinea pigs to know if
the sample is an allergen.
Inhalation toxicity test – Sample is sprayed for
30secs continuously for 10 times at 30mts
interval and the animals are observed for 4
days.
Secondary tests
• Implantation tests not only depend on the
material but also on its physical
characteristics. It can be short term (≤ 12
weeks) tests in subcutaneous tissue or
muscle in small animals or long term (≥ 12
weeks) tests in muscle or bone in bigger
animals
Preclinical Usage Test
Primary test → Secondary test → US FDA
Pre clinical usage

approval →→→→→→→→ Final approval
7 years
Preclinical Usage Test
• Pulp and dentin usage test.
• Pulp capping and pulpotomy usage test.
• Endodontic usage test.
Pulp And Dentin Usage Test
Restorative Material
Study – Non rodent

mammals.
Class V cavities
-ve Control – ZnOE
Specimens examined
at 7days, 283days,
and 705days
Pulp Capping and Pulpotomy Usage Test
Pulp Capping Material
Pulpotomy Material
-ve Control – CaOh

Specimens examined
at 72 days and 705
days
Endodontic Usage Test
Root Canal Sealers

- Ve Control ZnOE
Specimens examined
at 283 days and 131
weeks
O
F S
P
E
R T U
S C E
S
USAGE O E A OC
G S G O P
E NN R
SECONDARY
R T I
D
D
M
E I A
RA
A
PRIMARY S N Y
R
R Y
S G Y
NUMBER OF MATERIALS
USAGE
PRIMARY SECONDARY
Allergic Contact Dermatitis
• Occurs due to sensitization

• Clinical manifestation following exposure
can happen between 12 to 48 hrs.
• Incubation period can be between 2days
to several years.
• It can be confused with primary irritant
dermatitis.
• Commonest cause is latex allergy
Allergic Contact Stomatitis
• Most common reaction to dental materials

• Reaction commonly occurs locally, but can
at distant sites.
• Common allergens are Cr, Co, Hg,
Eugenol, Resin based materials,
Formaldehyde etc.
Oral Anatomy Influencing
Biological Response
• Enamel – Dentin – Pulp Environment
• Periodontal Attachment
• Periapical Area
CURRENT BIOCOMPATIBILITY ISSUES IN
DENTISTRY
LATEX
• 7% of surgical personnel may be allergic to latex.
• 3.7% of adult patients and 5.7% of pediatric patients
show adverse reactions to latex gloves.
• Reaction could be a true latex allergy or to accelerators
and antioxidants used in latex processing.
• Reactions vary from localized rashes to wheezing and
anaphylaxis.
• Identification of specific protein allergen is difficult
because of processing.
• Alternatives are to avoid the given batch, or use of vinyl
gloves or synthetic latex.
Nickel
• Most allergic metal known and more common in women.
• Known cross reactivity between Nickel and Palladium.
• High allergy frequency could be due to tendency of Nickel
containing alloys to release large amounts of Nickel ions
Beryllium
• Present in Ni – Cr alloys in conc. of 1 wt%.
• Beryllium is a documented carcinogen.
• Beryllium containing particles when inhaled may cause a chronic
inflammatory condition called berylliosis. It is a delayed
hypersensitivity reaction and affects dental technicians more.
Mercury and Amalgam
• Mercury is known toxic material.
• Whether mercury in amalgam has toxic effects is
controversial.
• 3 forms – metal (Hgº), inorganic ion (Hg2+), and several
organic forms.
• Metallic mercury is poorly absorbed (1-7%), methyl
mercury a product of bacteria or biological systems is
most toxic and more efficiently absorbed (90-95%).
• Metallic mercury enters through skin or by inhalation →
blood → fat and nervous tissues.
• Amalgam restoration release mercury vapor to cause 1-3 μg/day, and
wearing of amalgam leads to about 45 μg/day of mercury ingestion.
• Toxic effects are neurological or renal, ranging from paresthesia (at levels
≥500μg/kg) to ataxia (at levels ≥1000μg/kg), joint pain (at levels
≥2000μg/kg) and death (at levels ≥4000μg/kg). Lowest level for any
observable toxic effect is 3μg/kg.
• At chronic level the symptoms are more subtle and include weakness,
fatigue, anorexia, weight loss, insomnia, irritablity, shyness, dizziness and
tremors in extremities or the eyelids.
• Amalgams do not release mercury anywhere near toxic level, but the long
half life of mercury in the body cause concern (20 – 90 days).
• Studies have estimated that 450-530 amalgam surfaces would be needed to
produce observable effect.
• There are other constant source of mercury like air, water, diet (fish)
• Removal of amalgam restoration can markedly increase the plasma level of
mercury.
Estrogenecity
• Is the ability of chemical to act as the hormone estrogen in the body
• When the chemical is not produced by the body it is called
Xenoestrogen
• Affects the children more by altering the reproductive cycles.
• Bisphenol A which is the starting point for all composite resins is a
xenoestrogen, but is 1000 times less potent than native estrogen.
• E-screen assay is the test commonly used to assess xenoestrogen
activity.
• No evidence to confirm dental composites have estrogenic effects
SELECTION OF BIOCOMPATIBLE
MATERIAL
Define the use of the material
Define how the material has been tested
Risks and benefits……..

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Biocompatibility of Dental

Biomaterial is any substance, other than a

Pre clinical usage

Study – Non rodent

Pulp Capping Material

-ve Control – CaOh

Root Canal Sealers

• Occurs due to sensitization

• Most common reaction to dental materials

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