BIOCOMPATIBILIT

Y OF DENTAL
MATERIALS
DR.RAMASHANKER
Associate professor
Deptt. of prosthodontic
3rd nov2014 time-10-11am
 CONTENTS
 Introduction
 History
 Definition
 Requirements
 Tests for evaluation
 Allergic responses to dental materials

 Materials considered for biocompatibility

 Physical factors affecting pulp health

 Summary
 References
 Introduction
 Biocompatibility :- interaction
between body & material
 Body ↔ Material
 Placement of material creates
interface : dynamic
 Interface activity depends on:
- location of material
- its duration in body
- its properties
- health of host

3
 History
 Mid 1800’ s dentists tried new
materials for first time by directly
putting them in patient’s mouth

eg. Fox : fusible metal-bismuth,

lead & tin-melted & poured in
cavity preparation at appx.100o C

 G.V. Black tried his new ideas of

restorative materials, like early
amalgams in patients’ mouth
 Concept of protecting
patients- early 1960’s

 Regulations & ethics

introduced
 Organisations like
FDA,ANSI,ADA and
ISO .
 Definition

 Being harmonious with life & not having toxic or

injurious effects on biologic function.
(G.P.T. 8th edn.-2005)

 Ability of the material to elicit an appropriate

biological response in a given application in the body
(Kenneth J.A).
 Requirements for Dental Material
Biocompatibility

 Should not be harmful to pulp & soft tissues

 Should not contain toxic diffusible substances

 Should not produce allergic responses

 Should not be carcinogenic

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 Biomaterial

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.
(G.P.T. 8th edn.-2005)

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Classification of Biomaterials from
perspective of Biocompatibility

 Those which contact soft tissues within the oral cavity

eg. Acrylic resin

 Those which could affect health or vitality of pulp

eg. Liner, bases

 Those which are used as root canal filling materials

eg. Gutta percha
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Classification of Biomaterials from
perspective of Biocompatibility

 Those which affect hard tissues of oral cavity

eg. Implants

 Those used in dental laboratory

eg. Nickel, chromium, cobalt

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 ADVERSE EFFECTS FROM
DENTAL MATERIALS

• Classical biological reactions to materials are :

TOXICITY
INFLAMMATION
ALLERGY
MUTAGENICITY

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 TOXICITY
 Earliest response studied

 Earlier material containing LEAD posed a

risk to patient due to toxic property of lead

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 INFLAMMATION
 Involves activation of the host immune
system

 Histologically it is characterized by edema

of the tissue with infiltration of acute &
chronic inflammatory cells

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14
 ALLERGY
 Most common response that occurs when the body
recognizes a material as foreign

 Reactions involves all dimensions of immune

system

 An allergic reaction results histologically in an

inflammatory response that can be difficult to
differentiate between non allergic
inflammation or low grade toxicity .
Allergy

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 Allergic Responses to Dental
Materials

 Allergic Contact Dermatitis

 Allergic Contact Stomatitis

 Allergy to Latex products

 Allergic Contact Dermatitis

 Most common occupational disease

 Susceptibility & prior sensitization necessary

 Dose independent

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 Allergic Contact Dermatitis
 Usually occurs where body surface makes

direct contact with allergen.

eg. Monomers of bonding agent-

distal part of fingers & palmer aspect

of fingertips

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
 Patch Test
 Most definitive diagnostic test
 Suspected allergen applied to skin to produce small area
of allergic contact dermatitis

After 48 to 96 hrs

hyperemia, edema, vesicle formation & itching

Positive reaction
(Slavin and Ducomb,1989)

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 Allergic Contact Stomatitis

 Most common adverse

reaction to Dental Materials

A) Local/contact type lesions

B) Systemic/distant lesions

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 Allergic Contact Stomatitis
 Common allergens :- chromium, cobalt, mercury,
eugenol, components of resin based materials, &
formaldehyde

 Mouthwashes, dentifrices, lozenges, & cough drops

cause burning, swelling & ulceration of oral tissues.

 Lichenoid reactions :- Long-term effect in oral mucous

membrane adjacent amalgam & composite resins.
(Bratel and Johntell,1994)
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 Allergy to Latex Products

 Polyether component-main
causative agent
…March,1988

 Dermatitis of hand (eczema)

most common adverse
reaction

 Localized rashes & swelling to

wheezing & anaphylaxis
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 Repeated exposure & duration plays important role.

 Most serious systemic reactions occur when gloves or

rubber dam contact mucous membrane - generalized
angioneurotic edema, chest pain, rash on neck or chest
region and respiratory distress
…Blinkhorn and Leggate,1984

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Prevention: Use Vinyl gloves or gloves made of
other synthetic polymer gloves:-

Polythene gloves.
Powder free gloves.
Nitrile gloves.

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 MUTAGENIC REACTIONS
• Mutagenicity results when the components of the
material alter the base pair sequences of the DNA in
cells

• Dental materials or components such as nickel,

copper, beryllium, some components of root canal
sealers & resin based materials are mutagens
KEY PRINCIPLES THAT DETERMINE
ADVERSE EFFECTS

• Two key factors have paramount importance :

 Metal Corrosion or Metal degradation

 Surface Characterstics

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 CORROSION
• Biocompatibility depends on degradation process
• Biological response of corrosion products
depends on:
Amount
Composition
Form
Location in tissues

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 CORROSION
• Biological environment in contact also
determines the corrosion property
for eg:
 salivary esterases accelerate breakdown of dental
resins
 Ingestion of acidic substances may alter corrosion
of alloys or ceramics

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 SURAFCE CHARATERISTICS
• Surface different from the Interior region
• For eg: casting alloy
sealant
• EFFECTS OF SURFACE :
Ti alloys promote osseointegration
Rough surface promotes corrosion

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 Tests for Evaluation of
Biocompatibility

Aim
 To eliminate any potential harm or damage to oral or
maxillofacial tissues from a product or any
component of a product

 To modify or control the use by manufacturer &

operator to prevent cytotoxicity.

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 Tests for Evaluation of
Biocompatibility

 Biocompatibility tests are classified on three

levels (tiers) :-

1. Group I : Primary tests

2. Group II : Secondary tests
3. Group III : Usage tests

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 Group I : Primary Tests
 Advantages :-
 in vitro test, done in controlled experimental
condition
 Most rapid, economical & easily standardized
 Large scale screening

 Disadvantages :-
 Lack of relevance to in vivo use of material
 Lack of immune, inflammatory & circulatory
system 33
 Cytotoxicity Tests

 Material in a fresh or cured state → placed

directly on tissue culture cells or on
membranes overlying them.

e.g.. Agar (Agar overlay technique)

Barriers like dentin disks
 Genotoxicity Tests
 Determines carcinogenic/mutagenic potential

 Carried out on mammalian or non-mammalian cells,

bacteria, yeasts, or fungi.

 Evaluates gene mutations, changes in chromosomal

structure & other DNA or genetic changes caused by
dental materials.
 Genotoxicity Tests
 Ames Test :-
-Material is tested with mutant histidine dependant
bacteria
-Agent is added to culture medium consisting salmonella
typhimurium mutant gene which cannot produce histidine
-If carcinogenic :- salmonella species reversed to original
state, i.e.... start producing histidine again
 Group II : Secondary Tests
Advantages :-
 Intact biologic system to respond to a material
 Provide important bridge between in vitro
environment & clinical use of material

Disadvantages :-
 More expensive & difficult to control
 Time consuming
 Ethical concerns
 Group II : Secondary Tests
1. Systemic toxicity test :-
 Material administered to test animals e.g.. Rats-
orally or i.v.

 If > 50% animals survive material is

safe
 Group II : Secondary Tests

2. Skin irritation test :-

 Irritation is inflammation without intervention of
antibody or immune system.
 Material held in contact with shaved skin of rats
for 24 to 90 days
 Erythema & edema are examined & confirmed.
Group II : Secondary Tests

3. Skin Sensitization test :-

 Sensitization is inflammatory response requiring

participation of an antibody system specific for
material allergen.
 Done similar to irritation tests
 Group II : Secondary Tests
4. Inhalation toxicity test :-
 Performed on rats, rabbits or guinea pigs in
exposure chamber with aerosol preparations by
releasing spray material around head & upper
trunk of animals.
 Death within 2 to 3 min. very toxic
No death safe for human application
 Group II : Secondary Tests
5. Implantation test :-

 Only used for testing implants & endodontic

materials.
 Material placed subcutaneously,intramuscularly, or as
a bone implant at lateral cortex of femur or tibia or both
 Histopathological examination has to be done
 Observation period may be upto 1 year.
IMPLANTATION TEST
 Group III : Usage Tests
Advantage :-
 Material placed in an environment clinically relevant to its
use in clinical practice
Disadvantages :-
 Extremely complex & difficult to perform
 Exceptionally expensive & very time consuming
 Ethical concerns

 In animals : usage tests

 In humans : clinical trials

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Classical progression of biocompatibility tests
Newer schemes for progression of biocompatibility
tests
VARIOUS DENTAL MATERIALS
CONSIDERED FOR
BIOCOMPATIBILITY
 Metals : Amalgam & mercury
Nickel
Beryllium
Gold

 Resins : Acrylic Resins

Chemically cured composite resins
Light cured composite resins
 Cements : Silicate cement
Zinc Phosphate cement
Glass ionomer cement
Zinc oxide Eugenol cement

 Miscellaneous : Impression materials

Implant materials
 Amalgam & Mercury
 Mercury itself has no effect on pulp

 Pulp response related to condensation pressure

 Rate of diffusion into enamel & dentin-inversely

related to degree of mineralization.
 Mercury
 Elemental mercury, Inorganic ion & Methyl mercury

 Methyl mercury :-formed by biologic action of

elemental mercury; Absorbed 100% in gut; Most toxic

 Elemental mercury absorbed less than 0.01%

 65% to 85% mercury vapor that is inhaled is retained in

body
 Mercury Levels in Blood
 Subjects with amalgam restoration 0.7ng/mL

 Subjects without amalgam restoration 0.3ng/mL

 Lowest level at which earliest 35ng/mL

non-specific symptoms occur
Mercury Hazard to Dental Personnel
 Via inhalation & skin contact (allergic contact
dermatitis)
 Accidental spillage
 Handling with bare fingers
 Improper storage
 Improper retrieval of spilled mercury or waste
amalgam
 Faulty equipment
 Acute mercury poisoning :-
Rare; stomatitis & diarrhoea

 Chronic mercury poisoning :-

Weakness, fatigue, anorexia, wt. loss, insomnia,
irritability, shyness, dizziness & tremors in extremities.

 Methyl mercury poisoning :-

Paresthesia of extremities, lips & tongue; ataxia (gait
disturbance), & concentric constriction of visual fields
(Tunnel Vision)
Recommendations in Mercury Hygiene
1. Store in unbreakable tightly sealed containers
2. Clean-up spilled mercury immediately
3. Do not handle with bare hands
4. Salvage all amalgam scrap & store it under water
5. Use water spray & suction while grinding
6. Do not use ultrasonic condensers
7. Periodic mercury vapor level determination in clinic
8. Alert health personnel about hazards of mercury
9. Use of rubber dam
10. Provide adequate ventilation
 Nickel
 Most common cause of
allergic dermatitis
 Female : Male :: 10 : 1
 Intraorally : little chance
of allergy
 Nasal & sinus cancer
among nickel refinery
workers due to nickel
carbonyl
 Beryllium
 Component of base metal alloys

 Highest risk to dental technicians during melting &

trimming of alloy

 Berylliosis : inflammatory lung disease due to

inhalation of beryllium dust or fumes
 Beryllium
 Prevention :

• Confirm allergy by Patch test

• Avoid base metal restorations in patients with

known allergy

• Good ventilation & exhaust

 Gold

 Pure gold is inert

 Allergy to gold is very rare

(1 in 1 million)
Cements
 Acrylic Resin
 Cause allergic reactions
(denture stomatitis) when
used as denture base
material or provisional fixed
partial denture resin

 Highest risk for dental

professionals due to
frequent exposure to
unpolymerized monomer
Chemically Cured Resin Composites
 Require use of matrix pressure to enhance adaptation to
cavity walls : Potential pulp irritant

 Chronic pulpitis : persists for indefinite period, after

2 to 3 weeks, develop massive pulp lesion

 Thin coating of hard setting Ca(OH)2 cement

recommended for deep cavities
 Light-Cured Resin Composites
 Visible light cured systems : greater depth of cure, shorter
curing time, less porosity & more wear-resistant restorations
than UV light cured systems less pulp response

 Use twice the recommended time exposure to light

 Conservative cavity preparation & incremental curing;

no need for matrices & pressure, to gain adaptation
less toxicity to pulp
 Impression Materials
 Irreversible hydrocolloids :- Inhaling fine airborne
particles (dust) can cause silicosis & pulmonary
hypersensitivity.
Dustless/Dustfree alginate is preferred

 Elastomers :- Cellular toxicity levels

Polyether > Addition Silicone > Polysulphide
 Implant Materials

 Commercially pure Titanium & its alloys are the most

biocompatible restorative materials

 Bio-glass ceramics used as implant materials also

exhibit good biocompatibility
 Implant Materials
 Osseointegration :- Materials have very
low degradation rates, & tend to form
surface oxides that promote bony
approximation within 100Ao space
eg. Titanium, tantalum, several forms of
ceramics

 Biointegration :- Materials undergo

degradation to promote bone formation
without any intervening space
eg. Bio-glass ceramics
 PHYSICAL FACTORS
AFFECTING PULP HEALTH
 Microleakage
 Free penetration of fluids, micro-organisms & oral debris
along interface between restoration & tooth, progressing
down the walls of cavity preparation

 It can result in :-

1. Secondary/Recurrent caries acute/chronic pulpitis,

pulp abscess, etc.
2. Staining or discoloration
3. Sensitivity due to continuing Pulpal irritation
Nanoleakage vs Microleakage
 Prevention:-
1. Use bonding/adhesive techniques for better adaptation
of restoration to tooth surface

2. Regular monitoring of restoration

3. Use cavity varnish below amalgam restoration

(leakage space filled by corrosion products thereby
sealing cavity : but requires much time)
 Thermal Changes
 Temperature fluctuations in oral cavity may crack
restorative material or produce undesirable dimensional
changes Microleakage

 Thermal conductivity & coefficient of thermal

expansion

 Metals are good conductors of heat, causing sensitivity

with large metallic restorations
eg. Amalgam or gold inlays
Provide suitable base
 Galvanism
 Flow of current when two
dissimilar metallic restorations
oppose each other in oral cavity

 Due to different electromotive

potentials of opposing metals

 Saliva acts as electrolyte

 Contact Short-circuit
current flows through pulp
Pain & Discomfort
 Galvanism
 Current falls off if fillings are maintained in contact
due to polarization of cell

 Pain perception depends on patient sensitivity rather than

magnitude of current

 Magnitude of current depends on composition & surface area of

metals

eg. Alloy of stainless steel develop higher current density than

gold or cobalt-chromium alloys when in contact with amalgam
 Galvanism
 As size of cathode (eg. gold alloy) increase relative to
anode (eg. Amalgam), current density increases
 Larger cathode enhances corrosion of smaller anode
 Current density in non-gamma2 containing amalgam is
less than gamma2 containing amalgam

 Prevention :-
Placement of insulating base
Applying varnish on cavity walls
Proper planning of restoration
 Estrogenicity

• Ability of a chemical to act in the body in a

manner similar to that of an estrogen.
• Bisphenol A –xenoestrogen may act on
estrogenic receptors in cells.
• E-screen assay –relies on growth response
of breast cancer cells that are estrogen
sensitive .
 Summary
 Clinical Guidelines for selecting
biocompatible materials :

 Define the use of material

 Define how the material has been tested

 Think in terms of Risk & Benefit

 Conclusion

Benefits Risks

Clinical
Judgement
References:-
1) Philips’ Science of Dental Materials
- Kenneth J. Anusavice
2) Dental Material Sciences
- Combe
3) Dental Materials – Properties & Manipulation
- Craig
4) Color Atlas of Oral Pathology – 4th Edition
- Robinson & Miller
5) Essentials of Oral Pathology & Oral Medicine
- Cawson & Odell
Thank You
For a
Patient
Listening