 Introduction

 Definition
 Requirements of dental materials
 Tests for evaluation of biocompatibility
 Allergic responses to dental materials
 Standards that regulate the measurement of biocompatibility
 Reaction of other oral soft tissues to restorative materials
 Reaction of bone & soft tissues to implant materials
 Cause no harm” should be the motto of every dentist while providing dental care
to the patient.
 The mouth with saliva and inherent microflora is particularly daunting for
restorative materials
 Any dental material used in the oral cavity should be harmless to the pulp and
oral soft tissues.
 It should not contain any toxic substances that may be absorbed into the
circulatory system, should not induce any allergic reaction in the patient, and
should have no carcinogenic potential.
 Once the material is placed in the oral cavity, it should be able to exist in
harmony with the tissues.
 This ability of a material is termed biocompatibility, i.e., being compatible with
living tissues.
 HISTORICAL BACKGROUND
• Concept of ethical treatment of patients extends back to the time of
Hippocrates (460 – 377 B. C.)

•Mid 1800:dentists tried new materials for the first time by putting them
into patient’s mouth

•Concept of protecting the patient as a research subject is only 30-40 Years

old.

5
HISTORICAL BACKGROUND
The current philosophy about testing the biological properties of
dental materials in a systematic way evolved in the 1960s as the need
to protect patients became politically acute and as the number of new
materials increased.

Even G.V. Black used patients to test many of his new ideas for
restorative materials, such as early amalgams

6
 Biocompatibility is defined as the ability of a restorative material to induce an
appropriate and advantageous host response during its intended clinical usage
(Murray et al., 2007).

 The ability of a biomaterial to perform its desired function with respect to a

medical (or dental) therapy, without eliciting any undesirable local or systemic
effects in the recipient or beneficiary of that therapy, but generating the most
appropriate beneficial cellular or tissue response in that specific situation, and
optimizing the clinically relevant performance of that therapy (Williams, 2008)
 Biomaterial refers to any nonvital material intended to interact with biological
systems within or on the human body.
 Dental materials inserted into the oral cavity therefore belong to the group of
biomaterials
 Describes the ability of a material to perform with an appropriate host response
when applied as intended.
 A biocompatible material may not be completely “inert”; in fact, the
appropriateness of the host response is decisive.
 Besides this classic concept of biocompatibility (inert/ tolerable biomaterial), the
targeted influence of a biomaterial on the metabolism of adjacent cells has gained
an increasingly important function (bioactive materials).
 Surfaces of materials can be specifically pretreated (“biofunctionalized”), such as
by coating a titanium surface with signaling proteins (e.g., bone morphogenetic
protein to improve the attachment of bone tissue)
 Tissue engineering is a comparatively new area of biomaterial application.
 It is the science of design and manufacture of new tissues for the functional
restoration of tissues and organs (regenerative medicine/ dentistry).
 Nondegradable and (mainly) degradable biomaterials serve as scaffolds for
signaling molecules or cells, or both, and they are designed to actively interfere
with adjacent body cells.
 The biocompatibility of a material is mainly determined by its release of
substances through solubility or corrosion.
 These substances may damage cells, or, by stimulating cellular synthesis of certain
proteins (e.g., pro-inflammatory mediators such as interleukin-1 and interleukin-6),
induce inflammation.
 Likewise, the surface absorption or accumulation of proteins, or the interaction of a
material with the extracellular matrix, is important for the biological behavior of a
material (for example, the attachment of cells/bacteria on material surfaces).
 The adhesion of proteins (e.g., the formation of a pellicle by saliva proteins) is
influenced by a material’s chemical properties as well as its physical
characteristics (e.g., wettability, surface energy).
 Safety in relation to the evaluation of (dental) biomaterials means freedom from
unacceptable risks.
 Thus, safety does not stand for a complete lack of risks.
 As with the definition of the term “biocompatibility”, adequacy has an important
function with respect to safety.
 Side effects of a biomaterial are defined as those effects that, besides the intended
main function, are also characteristic for this biomaterial but are not wanted.
 A synonymously used term is “adverse effects.”

 Toxicity of a material describes the ability to damage a biological system by

chemical means. In higher organisms (animals, human beings), local toxicity – that
is, adverse reactions emerging at the application site – is differentiated from
systemic toxicity, in which adverse reaction appear in an area distant from the
application site.
 In dentistry, local reactions primarily occur in the pulp, the periapical
periodontium, and the gingiva/ oral mucosa.
 Immunotoxicity of a material describes adverse effects on the structure and
function of the immune system, for instance on relevant cells such as monocytes.
 These effects impair the host defense (e.g., against infection) or may cause tissue
damage, such as by chronic inflammation.
 Placement of a material in the body creates an interface that must exhibit both
biological and structural stability during the lifetime of the implanted device.
 These interfaces are dynamic, and their transitional functionality is dependent on
the quality of the junction and the biocompatibility of the material.
 The dynamics of the interfacial interaction affect the material’s biocompatibility
and its acceptance by the body, which depend on the shape, size, and location of
the material, its physical properties, its composition, and the stresses that develop
during function.
 Three major factors are linked to the success of dental materials:
 (1) material properties,
 (2) the design of the dental device, and
 (3) the biocompatibility of component materials.
 1. The chemical nature of its components
 2. The physical nature of the components
 3. The types and locations of patient tissues that will be exposed to the device
 4. The duration of the exposure
 5. The surface characteristics of the material
 6. The amount and nature of substances eluted from the material
 when a dental material is placed in a tooth, the interface between them is active
and dynamic.
 Four types of interactions can take place: (a) between the material and the pulp
(via the dentinal tubules), (b) between the material and the periodontium, (c)
between the material and the periapical bone, and (d) between the material and
the oral cavity.
 These interactions could produce changes either in the material or in the host,
which could be either beneficial or harmful.
 The arrows in this figure indicate the pathways
that foreign substances from a restorative
material, if present, take into the oral environment,
the tissue space next to the periodontium (PD),
the pulp chamber (P), or the periapical region
(PA).
 The periodontal ligament is also an important
tissue, since it is located in proximity to the pocket
or attachment area, which is often a site for
accumulation of biofilms and ions, atoms, or
molecules of substances released from the
cervical region of dental restorations that can
extend into this area.
 Such accumulations can be metabolized, which
could then change their biological properties.
 Adverse effects of a material are those effects that, besides the intended main function,
are also characteristic for this material but are not wanted when the material is put to
use.

 The adverse effects of dental materials can be subdivided into the following:
 1. Systemic toxicity
 2. Local toxicity
 3. Allergic reactions
 a. Cross-reactive allergy
 b. Concurrent allergy

 4. Other reactions
 a. Genotoxicity
 b. Mutagenicity
 c. Carcinogenicity
 d. Teratogenicity
 Toxicity of a material is the dose-related potential of a material to cause cell or
tissue damage.
 Most materials used in dentistry give out substances that may find their way to
different body organs via several pathways, namely, through the oral mucosa,
leakage into the periapex, aspiration through the respiratory tract, and absorption
through the gastrointestinal tract.
 Systemic toxicity is the toxicity in which adverse reactions appear in an area
distant from the application site.
 The systemic response depends on the following:
 1. Duration and concentration of the exposure
 2. Excretion rate of the substance
 3. Site of the exposure
 A response in the immediate vicinity of contact with a substance in the form of
adverse reactions is termed local toxicity.
 Tis is an unfavorable phenomenon usually observed at the place where the
material is used or in the surrounding locale, many times effecting injury to
different cells (cytotoxicity).
 According to Mosby’s Dental Dictionary, cytotoxicity is the description of the
extent of the destructive or killing capacity of an agent.
 Inflammatory response or possible allergic reaction adjacent to a class V resin-
based composite.
 A, Possible allergic reaction to
nickel alloy in watchband buckle.
 B, Bilateral erythema in a female
patient that may have been
associated with allergic reactions
to nickel in a recently cemented
metal-ceramic crown (left side of
photo) and in two metal-ceramic
crowns (right side of photo) of a
three-unit fixed dental prosthesis.
 C, Severe allergic reaction in the
lips of a patient who was exposed
to a nickel-containing orthodontic
wire
 Large blue-colored areas, typically referred to as an amalgam tattoo, which is a benign area of
discolored membrane in the mouth. These examples are not associated with allergic reactions to
mercury or any other metallic elements in the amalgam fillings.
 The discoloration is caused by small amalgam granules that have fallen into open wounds created
during the condensation and carving of amalgam fillings in prepared teeth (A and B) or retrograde
fillings in root apices
 A Palatal area that was exposed to an acrylic palatal appliance . B, Acrylic
appliance with embedded wire. C, Initial healing of palatal tissue shown in A within
2 to 3 days after removal of the palatal appliance

Allergic contact dermatitis on the
fingertip of a dentist
after contact with resin-based
composite
 Allergic contact dermatitis on
the fingertip of a dentist after
contact with resin-based
composite
 Pronounced gingivitis of an orthodontic patient (nickel-containing device) who
revealed a positive reaction in a patch test.
 The most important differential diagnosis would be “plaque-associated”
inflammation.
 b Persisting perioral and labial eczema of an orthodontic patient (copper–nickel–
titaniumwires).
 The patient had no intraoral symptoms, and there was complete regression after
replacement with titanium wires
 Allergy is an abnormal antigen–antibody reaction to a substance that is harmless
to most individuals.
 Allergic reactions are not dose dependent.
 An allergic reaction occurs when the body specifically recognizes a material as
foreign and reacts disproportionately to the amount of the material present.
 An allergic reaction to a substance can be triggered if the organism was previously
sensitized (exposed) to this compound.
 These allergic reactions are also called hypersensitivity reactions which require
previous sensitization of the allergen and are mediated by IgE.
 Type I, II, and III reactions tend to occur quickly and are modulated by
eosinophils, mast cells, or B lymphocytes that produce antibodies (IgE, IgG),
whereas type IV reactions tend to be delayed and are modulated by monocytes
and T-cells.
 Dental materials may cause allergies of types I and IV.
 The dose levels causing allergic reactions are generally significantly lower than
those causing toxic reactions.
 Allergies to various substances can occur simultaneously
 If an individual is allergic to a particular element, then it may be assumed that he will
also be allergic to chemically similar elements.
 Examples are nickel and palladium, which belong to the same main group in the
periodic table of elements.
 Patients who suffer from an allergy to nickel are very often also allergic to palladium
 A concurrent sensitization is generated by two allergens that are frequently
present at the same time within a material or in the environment.
 Thus by parallel exposure, they may elicit positive reactions in allergy testing. For
example, ethylene glycol dimethacrylate (EGDMA) and hydroxyethyl
methacrylate (HEMA) are compounds present in the dental composite material
which can act as allergens at the same time, thus producing concurrent allergy.
 Genotoxicity refers to the ability of substances released from materials to cause
alterations of the genome DNA.
 A transfer of these genetic damages to subsequent generations of cells can be
avoided by programmed cell death.
 Mutagenicity is the ability of a substance to pass genetic damages on to the next
generation.
 When the components of a material alter the base-pair sequences of the DNA in
the cells, mutagenic reactions (mutations) result; for example, metals such as Ni,
Cu, and Be are known mutagens.
 Carcinogenicity is the ability of a material or substances released from it to induce
malignant tumors.
 Teratogenicity is the ability of certain substances to cause malformations during
embryonic development.
 Biocompatibility of dental materials is characterized by many parameters such as
toxicity, allergenicity, genotoxicity, mutagenicity, carcinogenicity, and
teratogenicity.
 Hence, it is impossible to biologically characterize a test material by any single test
method.
 The material needs to be evaluated by conducting a series of structured in vivo
and in vitro tests
 The tests used to measure the biocompatibility of dental materials are as follows:
 1. In vitro tests
 2. Animal tests
 3. Usage tests
 Before a material is tested on animals and humans, it has to undergo a series of
laboratory in vitro tests
 There are more than 20 different cell culture tests that can be used to assess the
cytotoxicity of dental materials.
 Mouse fibroblasts (L-929, 3T3) or human epithelial cells (HeLa) are grown in a
monolayer in culture plates and are used for these tests.
 A monolayer culture consists of a single, closely packed layer of cells.
 Each component of the test dental material is then placed directly onto the cells
and its toxicity is evaluated over a short duration (normally >24 hours).
 used for testing the cytotoxicity of the leachable components of the test material.
 A monolayer cell culture is used for the test.
 The cells are stained with neutral red vital stain dye.
 A layer of agar is placed over this monolayer of cells.
 The test material is then placed over the agar layer and incubated for 24 hours.
 The presence of leachable toxic substances is manifested by loss of dye within the
cells as they lyse.
 a cellulose acetate filter having 0.45-mm filter pores is used.
 Cells are grown on one side of the filter and the test material is placed in contact
with the opposite surface of the filter.
 Any leachable substance from the test material must diffuse through the pores to
exert a cytotoxic effect on the cells.
 Dentin barrier tests simulate in vivo oral environment more closely by placing a
bovine dentin disc between pulpal fibroblasts and the test material.
 Cultures are permanently perfused with growth medium, which keeps the cultures
vital for up to several weeks.
 helps to identify specific components which may be responsible for pulpal effects
through dentin, an option not available with other testing methods.
 also help to identify compounds that repress or intensify the cytotoxic effect of a
substance by reducing or increasing dentin permeability
 special culture agar is used which is histidine-deficient.
 Genetically altered bacteria(Salmonella typhimurium) are used as test organisms,
which cannot grow and form colonies on this histidine-deficient medium.
 If the test material is mutagenic, the bacteria will begin to grow as soon as they
come into contact
 The micronucleus test is a genotoxicity test used for the detection of micronuclei
in the cytoplasm of interphase cells.
 A micronucleus is a small nucleus that forms whenever a chromosome or a
fragment of a chromosome is not incorporated into one of the daughter nuclei
during cell division.
 In this test, the experimental material is exposed to cell cultures of human or
rodent origin with and without an exogenous source of metabolic activation.
 The cells are then grown for a suffcient period to check for the formation of
micronuclei, which will indicate the chromosome-damaging potential of the
material
 The in vitro tests are fast, inexpensive, easily standardized, and can be used for
large-scale screening.
 The disadvantages are that these tests lack relevance to the in vivo use of the
material.
 The in vitro environment also lacks the complex coordination of systems (immune
system, circulatory system) that are present in an organism.
 Once the test material clears the in vitro test stage, it is then tested on animals.
 The test material is placed into an experimental animal.
 Common animals that can be used are mice, rats, hamsters, ferrets, and guinea
pigs.
 LD50 median lethal dose is the calculated dose of a chemical substance that causes
death of 50% of the experimental animals.
 This was the standard procedure for the determination of acute toxicity till the
1980s.
 But due to ethical and legal issues related to the use of animals, this test is not used
much and newer tests such as the limit test, where animals are spared, are
preferred.
 In limit test, a “fixed dose” (e.g., 5 g of material/kg of body weight) is administered
to the experimental animals (may be five animals).
 The test animals are then observed for up to 14 days, and any signs of toxicity are
noted.
 If no animal dies at the end of the test period, then there is no need to test a higher
dose.
 The “fixed dose” that was used becomes the “upper limit” for the amount of test
material that can be administered.
 If there is death of the animals following the administration of the “fixed dose,” then
a lower dose should be administered to the next set of animals and the results
evaluated accordingly.
 For implantation tests, materials are implanted subcutaneously, intramuscularly, or
in the bone of an experimental animal (rats, rabbits, etc.).
 After different periods of implantation of the material in the tissues (between 1
week and several months), the adjacent tissue is investigated macroscopically and
microscopically
 The material under investigation is first injected intradermally into the
experimental animal, together with Freund’s complete adjuvants (FCA), an
immunopotentiator.
 Seven days later, the same substance is applied topically to the same site for 2
days.
 It is intended to amplify the immunological effect by FCA and thus to increase the
sensitivity of the test.
 Fourteen days after thisinduction period, the test substance is applied on a
different area of the skin.
 Subsequently, the skin reaction is assessed after an appropriate exposure time
 In Buehler test, the material under investigation is first injected intradermally into
the experimental animal but without the application of FCA.
 Terefore, the Buehler test is considered to be more protective of the animals though
less sensitive than the maximization test.
 The in vivo version of micronucleus test is carried out on rodent bone marrow or
peripheral blood.
 This test is one of the most successful and reliable tests for genotoxic carcinogens.
 In animal tests, the test material can be directly allowed to interact with a complex
biological system of an animal.
 However, these tests are expensive, difficult to control, and time consuming.
 In addition, there are ethical issues on animal treatment to be considered.
 There is also a concern about whether animal species adequately represent the
human species
 Usage tests can be performed in animals or humans.
 Use of animals in usage tests is limited to larger animals with anatomy that closely
resembles humans.
 The test material is placed in an environment relevant to the use of the material
in clinical practice.
 The gold standard of usage tests are clinical trials that are performed in humans.
 Pulp compatibility of dental materials is naturally of great importance for its
clinical usage.
 It is carried out on teeth of experimental animals or on human teeth that have to be
extracted for orthodontic reasons.
 In both cases, class V cavities are prepared as atraumatically as possible and are
then filled with the test material.
 After a period of several days to months, the teeth are removed and histologically
prepared; the pulps are microscopically evaluated for signs of acute or chronic
inflammation
 The material to be tested is placed in the root canals of animal models after root
canal preparation.
 The animal models used are primates and dogs.
 To assess biocompatibility, histological evaluation of the apical tissues is done.
 Similarly, to opt for a suitable endodontic treatment, pulpal infection can be
provoked experimentally.
 However, both pulp/dentin test and the endodontic usage test present technical
and ethical problems using large experimental animals.
 Materials used for dental implants are inserted into the jaws of test animals.
 The test animals that can be used are primates, dogs, miniature pigs, guinea pigs,
and rats.
 Tissue reaction is assessed histologically, the tissue in contact with the implant
being of particular interest.
 The usage tests are clinically more relevant.
 However, they are complex and therefore difficult to perform; they are also
expensive and time consuming.
 There are also legal issues in clinical trials
 The ideal method to evaluate the biocompatibility of a material would be to test it
on human subjects.
 But because of legal and ethical issues, this is not possible.
 In order to protect human health, a test material can be tried on humans
 only if it clears the in vitro, animal, and usage (on animals) tests.
 Once a material passes through the in vitro and animal tests, an IND (Notice of
Claimed Investigational Exemption for a New Drug) application which details the
following points is submitted to the FDA for approval:

 1. Novelty of the test material, its composition, and manufacture

 2. Results of all the in vitro and animal tests conducted on the test material
 3. Proposed application of the material, availability, and method of use
 4. Methods to determine the safety of the drug and its outcome in humans
 After the material is FDA approved, it can then be subjected to the following three
phases of a clinical trial:
 1. Phase I trials: In this phase, the material is tested in a few healthy individuals
after obtaining informed consent.
 The test material is applied/administered in increasing increments in the
individuals until the required result is achieved or till the individual experiences an
adverse effect.
 In this way, the “Safe dose” of the material is determined.
 2. Phase II trials: In this phase, the material is tested in a small group of patients.
The aim of this phase is to determine the “Therapeutic dose” of the material.
 Phase III trials: The test material in this phase is subjected to a large-scale
study.
 The studies must have a suffcient number of subjects, and the allotment of these
subjects to the control and test groups must be unbiased.
 The test groups must comprise other materials with which the test material can be
compared.
 The aim of this phase is to prove that the test material is “Safe and Effective.”
 The data obtained from these trials is then submitted to the FDA in NDA (New Drug
Application).
 The FDA then designates the test material as either “complete” or “incomplete.”
 A “complete” test material is permitted for marketing while an “incomplete”
material must be subjected to more tests before it is accepted.
 4. Phase IV trials: Reports regarding any allergies, interaction with other
materials, and the amount of material circulated/distributed must be reported to
the FDA at timely intervals.
 This will aid in recognizing any delayed adverse effects of the material
REGULATIONS & STANDARDS
 Acc. To Medical Device Directive(MDD) : -
A medical device is applied as a device used for diagnosis,
prevention, monitoring, treatment or alleviation of disease.
 Does not achieve its principal intended action in or on the humans by
Pharmacological, Immunological or metabolic means.
 E.g. Dental material

 European Economic area - MDD

 United States – FDA

89
 A multiplicity of laws,
standards and Laws
recommendations regulate the Standards
marketing of medical devices, Recommendations
generating the impression that
dentist can exclusively rely on
them( eg. CE Labeling).

90
REGULATIONS & STANDARDS
 Safety data sheets.
 safety labels on the
wrappings
.

91
REGULATIONS & STANDARDS
•Horizontal Standards
(valid for all medical
devices)
•Semihorizontal
Standards (valid for
groups of products
such as Dental
materials)
•Vertical Standards
( valid for individual
materials such as
amalgam)

92
 ANSI/ADA Document 41
 Biological testing of Dental Materials
 1972, 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 standard 10993

 Biological evaluation of medical devices
 International standard
 Not restricted to dental materials (horizontal standard)

93
Biocompatibility Of Various
Dental Materials

94
RESIN BASED COMPOSITES
Anterior and posterior filling materials

 Luting composites(eg for luting ceramic & indirect
composite restorations and crown build ups)
 Bonding of brackets and orthodontic bands.
 Temporary crowns & bridges
 Pit & fissure sealants
 Auxiliary materials -acids and adhesives.

96
 Resin based materials :

 MMA, HEMA, TEGDMA,

EGDMA,Formaldehyde &
Glutaraldehyde
silicon, Boron, sodium and Barium

 Light cured < cytotoxic than

chemically cured

 Pulpal reaction diminishes after 5 –

8 weeks

 Protective liner or bonding agent

minimizes Pulpal reaction

97
Extraoral allergic reactions
(type I) after application of a
pit and fissure sealant

Allergic contact dermatitis of a

dentist after contact with resin-
based composites

98
Chemical burn after
inadvertent contact of
phosphoric acid with
gingiva

Gingivitis adjacent to
a cervical composite
resin filling

99
 Light curing units

 Hazardous to eyes
 Afterimages( Reversible)
 Photochemical damages(loss of acuity)(irreversible)
 Protective glasses/ protective shields

100
ZINC PHOSPHATE CEMENT
pH - 2 at 2mints => 5.5 after 24
hours
No systemic or allergic reactions
Cytotoxic – immediately
When placed in VITAL TEETH?
Inclusion of Ca- OH to the
powder or lowering the
concentration of phosphoric acid

101
Zinc phosphate cement
that was left in the sulcus
after cementation results
in periodontal destruction.

102
GLASS IONOMER
CEMENTS
 Luting agent & restorative material

 Histological studies in usage test shows that

any inflammatory infiltrate to ionomer is
minimal or absent after 1 month.

103
CALCIUM HYDROXIDE CEMENT
Suspension form Resin
containing

Highly cytotoxic Mild to moderate

Necrosis 1mm or > No necrotic zone
shortly
Dentine bridge formation Dentine bridge
formation
is quick

104
ZINC OXIDE EUGENOL CEMENT
Max Eugenol release- within first 5
hour(4-5%)
Antimicrobial properties against a
great variety of bacteria

Reaction of the gingiva after

temporary cementation of a crown with
a zinc oxide and eugenol cement.

105
PRECAUTIONS DURING
CEMENTATION
Apply petroleum jelly to the surrounding soft tissues

Clean the excess cement after luting the prosthesis

Any residues of cement left in the gingival sulcus will

lead to inflammation

106
DENTAL CERAMICS
Biocompatible,,Few are Cytotoxic - in vitro

Auxiliary materials
HF acid
If HF comes into contact with skin or mucosa, it may not cause
immediate chemical burn, but within 24-48h, deep tissue necrosis
occurs.
2%HF- erosion of the cornea.

1.23% APF gels may roughen the ceramic surfaces, subsequently

increasing plaque accumulation.

Occupational exposure in labs

Radioactivity of Zirconium Oxide > Al2O3 & SiO2

107
Casting
alloys 108
DENTAL ALLOYS
25 elements
Phase Structure – corrosion properties & biocompatibility
B.C- Released elements, quantities, duration of tissue exposure
Ni & Cu – gingivitis
High Gold & Gold alloys – discolorations & hyperplasia of gingiva
 Thermal treatment ( Ceramic alloys)- cytotoxic
Incomplete removal of oxide layers-gingivitis

109
Metal ions acts as Haptens + resident molecules =
complex (foreign)
Cross reactivity – Pd & Ni allergy
Medical history-Allergy to Jewelry, watches, metal
attachments to clothing, etc.

110
gingivitis due to the PFM
crowns;

after removal of the crowns

and seating of
temporary resin crowns

111
Gold coating of nickel-
based and cobalt-based
alloys.

Pronounced redness of the

palate beneath the denture
base.

112
Perioral allergic reaction
after insertion of nickel-
containing orthodontic wires
(CuNiTi)

Lichenoid reaction of
the mucosa contacting an
alloy

113
Pronounced gingivitis after
seating of ceramic crowns,
despite good oral hygiene

Dental lab –Inhaled beryllium –

berylliosis.

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ORAL HYGIENE
PRODUCTS
Toothpastes & Mouthwashes

 Alcohol
Fluorides
Abrasives
Chlorhexidine
.
Allergens are
Flavoring Agents – cinnamon, peppermint, spearmint
Chlorhexidine
Others – acetamide, azulene, benzoates, Choroacetamide, propolis.

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 ORAL HYGIENE
PRODUCTS
Mechanical abrasion of
tooth substance

Allergic contact cheilitis

from spearmint oil in a
toothpaste

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Bleaching agents :
Catabolism of H2O2 => O2 & water
Venous embolization
Cerebral Infarction – 35% H2O2
Dental Hypersensitivity

In-Vitro – traverses the dentine & in sufficient conc. can be

cytotoxic

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TOOTH BLEACHING
AGENTS
Skin lesions on a dentist’s
fingertips, caused by unintentional
contact a bleaching agent in a
dental office

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Impression materials

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IMPRESSION MATERIALS
Silicones – A & C
Polyether
Polysulphides
Hydrocolloids
Alginate
ZnOE

Additional silicones , hydrocolloids and alginate –

nontoxic
 least biocompatibility applies to condensational
silicones

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Distinct local toxic effects- mixing of putty
materials
Latex-may impair the polymerization
Eyes must be protected by appropriate glasses
when liquid catalysts are used
Periodontal sulcus has to be carefully
monitored for remnants of impression materials

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LATEX

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 BARRIER MATERIALS
Latex :
 6% to 7% of surgical personnel may be allergic
 42% adverse reactions to occupational materials
 Hypersensitivity may be due to true latex allergy or
reaction to accelerator & antioxidants
White, milky sap

Addition of ammonia

Hydrolyses & degrades the sap proteins to produce

allergens

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Liquid vulcanization solid
latex sulphur + heat rubber

 Soaked in hot water leaches out allergens

 Allergenicity depends on collecting, preservation & processing

124
 BARRIER MATERIALS
•Contact urticaria following
occupational exposure to
latex proteins in disposable
gloves

•severe irritative hand

dermatitis (non allergic)
caused by frequent hand
washing and wearing of
disposable gloves

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Implants

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REACTION OF BONE & SOFT
TISSUES TO IMPLANT MATERIAL
 Materials – Ceramics, Metals, & Polymers

 a) Reaction to ceramic implant material

 Very low toxic effects.
 Oxidized state, corrosion resistant

 b) Hydroxyapatite
 Relatively non resorbable form of calcium phosphate
 Coating material & ridge augmentation material

 c) Beta -Tricalcium phosphate

 Another form of calcium phosphate, has been used in situations
where resorption of the material is desirable
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 d) Reaction to pure metals & alloys

 ‘Metal’ oldest type of oral implant material

 Shares the quality of ‘strength’

 Initially selected on the basis of the ‘Ease of

fabrication’
 Stainless Steel, Chromium-Cobalt-
Molybdenum, Titanium and its alloys
 Most commonly used is Titanium

 Titanium’s Biocompatibility is associated with

its fast oxidizing capacity.
 Corrosion resistant & allows Osseointegration

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Soft tissue :
 Epithelium forms a bond
with implant similar to that
of tooth
 C.T apparently does not
bond to the titanium, but
forms a tight seal that
seems to limits ingress of
bacteria & its products

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 CONCLUSION

 It is often difficult for clinicians to evaluate the biological safety of new materials.
However, with thorough knowledge of biocompatibility issues and some common
sense, clinician can make reasonable judgments’ about biological safety.

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REFERENCES
Text Books
 Biocompatibility of dental
materials –Gottfried Schmalz &
Dorthe Arenholt – Bindslev
Restorative dental materials (11
edition) – G. Craig & John H. Powers
PHILLIPs’ Science of dental
material
(11 edition)

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