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SRI GANESH
INDIAN DENTAL ACADEMY
Leader in continuing dental
education
www.indiandentalacademy.com
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Biological properties
of Dental materials.
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Contents
 Introduction
 Biocompatibility v/s Biological properties
 Components of biocompatibility
 Adverse effects of dental materials
 Toxicity
 Inflammation
 Allergy
 Mutagenicity
 Carcinogenicity
 Local & Systemic effects of materials
 Key principles that determine adverse effects from materials
 Concept of Immunotoxicity
 Oral anatomy that influences the biological response
 Enamel
 Dentine & Pulp
 Bone
 Measuring the biocompatibility
 Invitro tests
 Animal tests
 Usage tests
 Clinical trials
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 Advantages & disadvantages of biocompatibility tests
 Correlation among the tests
 How tests are used together ?
 Regulatory standards for measurement of biocompatibility
 Current biocompatibility issues in dentistry
 Reaction of pulp to different materials
 Dentine bonding & Dentine bonding agents
 Dental amalgam
 Dental cements
 Bleaching agents
 Latex
 Impression materials
 Biocompatibility of metals
 Reaction of other oral soft tissues to restorative materials
 Denture base material
 Soft denture liner & adhesives
 Reactions of bone & soft tissues to Implant materials
 Conclusion
 List of references
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Introduction
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Biological properties of Dental
materials
 Biocompatibility = Lack of interaction
 Biocompatible material = list of negatives
 Non degradable
 Non irritant
 Non toxic
 Non allergic
 Non carcinogenic
 Non mutagenic
 Total inactivity = Passive ignorance ?
 More appropriate – active acceptance
 Biocompatibility : ability of a material to perform with an
appropriate host response, in a specific application.
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Components
 Initial Physiochemical interaction
 Effect of the tissue environment
 Local host response
 Transport of products – Systemic effects
 Establishment of solid-liquid interface as any material is
implanted into the tissue
 Protein absorption is the first event
 Immediate response to injury is inflammation
 Very few is know about the factors
 Condition of the host
 Properties of the material
 Context in which the material is used
Eg: Biocompatible as Crown & Bridge but not as an implant material
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Adverse effects from Dental
materials
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Toxicity
 Placement of a foreign material in the body carries the possibility
of toxicity
 Toxicity can be of 2 types
 Acute toxicity.
 Chronic toxicity.
 Type 1: requires prolonged or repeated administration
 Type 2: requires very few or one dose but long lasting effects
 Type 1 chronic toxicity is a possibility with “Biomaterials”
Eg: metal ions released by gradual corrosion of an implant
 According to J.J.Jacobs et al (1991)
 Vanadium – lungs
 Aluminium – surrounding tissues
 Fortunately, materials causing over toxicity are no longer used in
dentistry.
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Inflammation
 May result from toxicity or allergy and often it
precedes toxicity.
 Oedema, inflammatory cell infiltrate
 Current biocompatibility researchwww.indiandentalacademy.com
Allergy
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Allergy
 Body specifically recognizes material as foreign &
reacts disproportional to the amount of material
 Gell & Coomb‟s classification of immune responses
 Type 1: Atopic or anaphylactic reaction
 Type 2: Cytotoxic hypersensitivity reaction
 Type 3: Immune complex disease
 Type 4: Delayed or cell mediated hypersensitivity
 Type 5: Stimulating antibody reaction
 Type 6: antibody dependent, cell mediated Cytotoxic
reaction
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 Type 1, 2, 3 – quickly. Eosinophils, Mast cells & B
lymphocytes
 Type 4 – delayed. Monocytes & T cells
 Allergic response – individual‟s immune system
recognizes a substance as foreign
 Allergic reactions – initially dose
independent, disproportionate
 Toxic / inflammatory reactions – dose
dependant, proportionate
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Mutagenic reactions
 Alteration in base pair sequence (mutation)
 2 types
 Alteration in cellular process that maintain DNA integrity
 Direct interaction
 Can occur from radiations, chemicals, errors in DNA
replication process
 Examples
 Metal ions – nickel, copper, beryllium
 Few components of root canal sealers
 Resin based materials to some extent
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Carcinogenic response
 Currently no dental material has been shown to be
carcinogenic for dental applications in patients
 However, carcinogenesis is often exceedingly
difficult to prove or disprove conclusively
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Local & Systemic effects of
materials
 Local effects
 Pulp
 Periodontium
 Root apex
 Oral tissues – buccal mucosa, tongue
 Systemic effects
 Function of the distribution of substances released from the materials
 Simple diffusion
 Lymphatics
 Blood vessels
 Access to the body by
 Ingestion & absorption in gut
 Inhalation
 Release at tooth apex
 Absorption into mucosa
 Systemic response depends on
 Duration & concentration of the exposure
 Excretion rate of the substance
 Site of the exposure
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Key principles that determine
adverse effects from materials
 A) various types of metal corrosion & other types of
material degradation :
 Biocompatibility depends on the degradation process
 Corrosion is determined not only by material composition
but also by the biological environment
 Many ways for release of products in host
 Metal prosthesis – releases metal ions by
 Electrochemical force
 Particles dislodged by mechanical forces
 Resin composites
 Cyclic stresses
 Salivary esterases
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 B) Surface characteristics :
 Surface is quite different from interior
 Examples
 Dental casting alloy containing 70% gold may have 95%
gold at its surface
 Relative unpolymerized state of a sealant at its surface
 The surface composition, roughness, mechanical &
chemical properties are critical to the biocompatibility
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Concept of
Immunotoxicity
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Concept of Immunotoxicity
“ Based on the principle that small alteration in
the cells of immune systems by materials can
have significant biological consequences ”
 Examples:
 Mercury ions increase the Glutathione but
Palladium decreases Glutathione content of
Monocytes
 HEMA may change the ability of Monocytes to
direct an immune response once challenged by
plaque or others agents
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Oral anatomy that influences
the Biological response
 Enamel : “seals” the
tooth
 Peroxides permeate
intact enamel
 Dentine & Pulp :
 Smear layer
 Effective in reducing the
hydrostatic pressure but
not diffusion
 Acid etching
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 Bone : Osseointegration & Biointegration
 Osseointegration
 Implant & bone closely approximate to each other
 Approximation less than 100 A
 No fibrous tissue in intervening space
 Titanium alloys
 Biointegration
 Implant & bone are fused to one another & are
continuous
 Occurs with Ceramic & Ceramic coated metal implants
Eg: Calcium & Tri calcium
phosphate, Hydroxyapatite, Bioglass
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Measuring the
Biocompatibility
 Is not simple and methods of measurement are
evolving rapidly as more is know about the
interactions between dental materials and oral
tissues & as technologies for testing improves
 Classified as
 In Vitro test
 Animal test
 Usage test
 Clinical trial – special case of a usage test in humans
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In Vitro test
 Placement of a material
or component of it in
contact with
cell, enzyme or some
other isolated biological
system
 Direct
 Material in contact
 Physically present or
extract from material
 Indirect
 Some sort of barrier
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Types of cells used in In-vitro
assays
 Primary cells :
 Directly from an animal into culture
 Grows for only a limited time
 Continuous cells :
 Primary cells transformed to allow them to grow
indefinitely
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Testing procedures & extent of
testing
 Manufacturer‟s responsibility to test new material
 A) Initial tests :deals with general biocompatibility & systemic
effects of a material
 Short term systemic toxicity test
 Short time oral administration
 Toxicity profile
 Acute systemic toxicity test
 I.V administration
 Inhalation toxicity test
 Dental remedies that have significant volatility under usage condition
 Hemolysis test
 In vitro evaluation of hemolytic activity of materials intended for
prolonged tissue contact
 Emes mutagenicity & the dominant lethal test
 To asses the potential carcinogenic activitywww.indiandentalacademy.com
Cytotoxicity tests
 Measures cell count or growth after exposure to a
material
 Method 1 :
 Place the cells in the well of a cell culture dish
 If Cytotoxic - cell may stop growing, exhibit cytopathic
features or detach from the cell
 Method 2 :
 Measurement of cytotoxicity by a change in membrane
permeability
 Loss in membrane permeability is equivalent or very nearly
equivalent to cell death
 Identifies the cells that are alive or dead
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Tests
 Sensitization test
 Oral mucous membrane irritation test
 Subcutaneous implant test
 Bone implant test
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Usage tests
 Pulp &Dentine test
 Response of dentine & pulp
 Minimum experimental variables
 Pulp capping & Pulpotomy test
 Endodontic usage test
 Assess response of the pulp wound & the periapical tissue
 Influenced by – level at which the pulp tissue is cut off &
total removal of pulp tissue
 Bone implant usage test
 To evaluate all materials that, during their intended
use, penetrate the oral mucosa and the adjacent bone
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Correlation among the tests
 Lack of correlation
 Less prominent biological response
 Barriers may exist
 Measure different aspects of the biological
response to the material
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Advantages & disadvantages
of Biocompatibility tests
 In-Vitro test
 Advantages
 Quick to perform
 Least expensive
 Standardized
 Large scale screening
 Excellent for mechanisms of interaction
 Disadvantages
 Relevance to In-Vivo questionable
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 In- Vivo test
 Advantages
 Allows complex systemic interactions
 More comprehensive
 More relevant
 Disadvantages
 Relevance to use ?
 Expensive
 Time consuming
 Ethical concern
 Difficult to control
 Difficult to interpret & quantify
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 Usage test
 Advantages
 Relevance to use of material is assured
 Disadvantages
 Very expensive
 Time consuming
 Major legal / ethical
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usage progression
secondary of
primary testing
 Linear paradigm, relies on the accuracy of the primary tests (challenged by
Major et al 1977)
 No prediction of results in usage tests
 Lack of correlation in In-Vitro tests
How the tests are used together
to measure the Biocompatibility
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 Non linear thinking
U Progression
S of
P Testing
 All the 3 tests are done
 As test progresses Usage test predominates
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 Most common progression
Usage
„Recognizes
Primary Secondary complexity‟
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Standards that regulate the
measurement of Biocompatibility
 ANSI / ADA : earliest attempt in 1933
 1972 – The Council on dental
material, instruments & equipment of ANSI / ADA
approved document no. 41 for recommended
standard practices for biological evaluation of
dental materials
 In 1982 updated to include test for mutagenicity
 Uses linear paradigm
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 ISO Standard 10993 :
 Not restricted to dental materials only
 First published in 1992
 In 2002 ISO 10993 consisted of 16 parts
 2 types of tests –
 Initial – Cytotoxicity, sensitization & systemic toxicity.
In – Vitro / animal test
 Supplementary – chronic toxicity, carcinogenicity &
bio-degradation. Animals / Humans
 Specialized tests – Eg: dentine barrier test
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Current Biocompatibility
issues in dentistry
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 Reactions of pulp to
different materials
 Micro leakage :
 If a material does not
bond or debonds at
enamel or dentine
 Previous belief
 Concept of nano leakage
 Between mineralized
dentine & bonded
material. In very small
spaces of
demineralized matrix
into which material did
not penetrate
 Hydrolytic degradation
of dentine – material
bond
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 Dentine bonding :
 Bonding to dentine is
difficult –
composition, wetness, lo
w minerals
 Smear layer formation &
removal
 Many studies have
shown
 0.5mm of RDT is
adequate
 Dentine is a buffers of
protons
 Penetration of acids <
100 micrometers
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 Dentine bonding agents :
 HEMA is 100 times less cytotoxic in tissue culture
than Bis – GMA
 Bis – GMA, TEGDMA, UDMA
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Amalgam
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 Dental amalgam :
 Toxic or not ?
 In usage test response of
pulp to amalgam in shallow
or deep lined cavities
 Gallium based amalgam
 Excessive gallium release,
roughness, discolor
 Significant foreign body
reaction
 Absorption : 1 – 3
micrograms / day
 Minimum dose to produce
observable toxic effect is 3
micrograms / kg body
weight
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 Dental cements
 Resin based materials :
 Resin composites –
luting or restorative
 Light cured < cytotoxic
than chemically cured
 Pulpal reaction
diminishes after 5 – 8
weeks
 Protective liner or
bonding agent minimizes
Pulpal reaction
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 Glass ionomers :
 Luting agent &
restorative material
 Weaker polyacrylic acid
 Fluoride release
 Histological studies in
usage test shows that
any inflammatory
infiltrate to ionomer is
minimal or absent after 1
month
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 Zinc phosphate :
 Luting agent & base
 Thermal conductivity closer
to enamel
 Pulpal damage in first 3
days due to initial low
PH(4.2), reaches neutrality
in 48 hours
 When placed in deep
cavities ?
 Inclusion of Ca- OH to the
powder or lowering the
concentration of phosphoric
acid
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 Calcium hydroxide :
Suspension form Resin containing
Highly cytotoxic Mild to moderate cytotoxic
Necrosis 1mm or > No necrotic zone
shortly
Neutrophil infiltration Dentine bridge formation
5 to 8 weeks is quick
Slight inflammatory response
wks - months
Dystrophic calcification
Dentine bridge
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 Zinc oxide eugenol :
 Suppresses the nerve transmission
 Inhibit synthesis of Prostaglandins & Leukotriens
 Hammesfahr 1987, initiated the search for a
biocompatible resin base system incorporating
Calcium hydroxide “ PRISM VLC DYCAL”
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Soft tissue response to the
luting cements
 Apply petroleum jelly
 Clean the excess
 Any residues of cement
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 Bleaching agents :
 Usually contain some form of peroxide
 In-Vitro – traverses the dentine & in sufficient
conc. can be cytotoxic
 Penetrates intact enamel & reaches the pulp in
few min.
 May burn gingiva
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Latex
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 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
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Impression materials
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 Impression materials :
 Price & Whitehead
(1972) – Allergic
contact stomatitis &
Foreign body response
 Sydiskis & Gerhardt
(1993) – some degree
of toxicity in cell culture
 Gabriela Mazzanti et al
(2005) – no significant
evidence of diffuse
inflammation or local
skin reaction www.indiandentalacademy.com
Casting alloys
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 Dental casting alloys :
 John c. Wataha 2000
 Release of elements is essential for adverse effects
 Identifying & quantifying the elements that are
released is most relevant measure from stand point of
Biocompatibility
 a) Release of elements from casting alloys
 Multiple phases
 Inherent tendency to release elements – lability
Eg: Cu, Ni, Cd, Zn & Ga – highly labile
 Environmental conditions - PH
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 b) Systemic toxicity
 Released metals may not be inside the body
 Route of access – I.V < Peritoneal < Oral
 Distribution – there is no documented proof that
these material cause „Systemic toxicity‟
 c) Local toxicity
 Micro environment exists around casting alloys
 Metal ions can cause local toxicity
 Increased exposure causes increased toxicity
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 d) Allergy to dental casting alloys
 Elemental release is essential for allergy
 Metal ions – Haptens
 Allergy & Toxic reaction – difficult to distinguish
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 Patch test for metals – controversial
 Application of metal ion to skin in the form of patch
 Injecting small amount of ion below the skin
 Assessment of the response is difficult
 Salt of metal ions important for response
Eg: chloride, sulphate, nitrate salts
 Vehicle – whether its water, oil or petrolatum can vary
the response
 Grimaudo N.J 2001 – true allergic hypersensitivity to
dental casting alloys is rare
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 Nickel :
 Common component
 Incidence of allergy 10% – 20%
 Cross reactivity between nickel & palladium (33%
& 100%)
 Nickel ions induces ICAM‟s in the endothelium –
release of cytokines
 It may contribute to any intraoral inflammation
around nickel containing crowns
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 Beryllium :
 Used in Ni-Cr alloys in conc. of 1 – 2 wt%
 Forms thin adherent oxides
 Documented carcinogen
 Berylliosis
 Individual is hypersensitive
 Inhalation of beryllium dust, salts, fumes
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Reaction of other oral soft tissues
 a) Denture base
materials
 Methacrylates
 Greatest potential for
hyper sensitization
 Acrylic & diacrylic
monomers, curing
agents, antioxidants, ami
nes, formaldehydes
 For the patients most of
these materials have
been reacted in
polymerization and thus
less prone www.indiandentalacademy.com
 True allergy of oral mucosa to denture base
material is very rare
 Residual monomer (methyl methacrylate)
 Allergic acrylic stomatitis
 Heat cured is better
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 b) Soft denture liners &
adhesives
 Release of plasticizers
 Extremely cytotoxic
 Effects are masked by
the inflammation
 Denture adhesives show
severe cytotoxic
reactions In-Vitro
 Large amount of
formaldehyde
 Allowed significant
microbial growth
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Denture cleansers
 Used to cleanse the prosthesis
 Eg : Hypochlorite, mild acids, etc.
 Biocompatible & cause no harm to the patient
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Artificial teeth
 Acrylic & Porcelain teeth
 Acrylic teeth is preferred in poor ridges
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Implants
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Reaction of bone & soft
tissues to implant material
 Materials – Ceramics, Metals, Carbons & Polymers
 a) Reaction to ceramic implant material
 Very low toxic effects. Oxidized state, corrosion resistant
 Used as a porous or dense coating
 Root surface porosities > 100microns (firmly bound )
 Root surface porosities < 100microns (fibrous ingrowth)
 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
www.indiandentalacademy.com
 Soft tissue :
 Epithelium forms 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
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List of references
 Restorative dental materials by Craig & Powers
 Phillips‟ Science of dental materials
 Chemistry of medical & dental materials by J.W.Nicholson
 Concise Encyclopedia of medical & dental materials by David Williams
 Dental biomaterials by Arturo N. Natali
 Dent material 2005;21(4):371-74
 JPD 2001 Aug;86(2):203-9
 Gen Dent 2001 Sep-Oct;49(5):498-503
 JPD 2000 Feb;83(2):223-34
 JPD 1998 Sep;80(2):203-9
 JPD 1993;69;431-5
 J Biomater Appl 1987 Jan;1(3):373-81
 BDJ 1972;133:9-14
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Precautions to be taken in the
Lab
 Make certain the ventilation system in room is
properly functioning
 During operation of the dental lathe wear a
protective eyewear & a mask
 Clean & disinfect the dental lathe at least
once daily
 Use sterile rag wheels, stones & fresh
pumice for each patient's prosthesis
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Thank you
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Biological properties of dental materials 1 /certified fixed orthodontic courses by Indian dental academy

  • 1. SRI GANESH INDIAN DENTAL ACADEMY Leader in continuing dental education www.indiandentalacademy.com www.indiandentalacademy.com
  • 3. Biological properties of Dental materials. www.indiandentalacademy.com
  • 4. Contents  Introduction  Biocompatibility v/s Biological properties  Components of biocompatibility  Adverse effects of dental materials  Toxicity  Inflammation  Allergy  Mutagenicity  Carcinogenicity  Local & Systemic effects of materials  Key principles that determine adverse effects from materials  Concept of Immunotoxicity  Oral anatomy that influences the biological response  Enamel  Dentine & Pulp  Bone  Measuring the biocompatibility  Invitro tests  Animal tests  Usage tests  Clinical trials www.indiandentalacademy.com
  • 5.  Advantages & disadvantages of biocompatibility tests  Correlation among the tests  How tests are used together ?  Regulatory standards for measurement of biocompatibility  Current biocompatibility issues in dentistry  Reaction of pulp to different materials  Dentine bonding & Dentine bonding agents  Dental amalgam  Dental cements  Bleaching agents  Latex  Impression materials  Biocompatibility of metals  Reaction of other oral soft tissues to restorative materials  Denture base material  Soft denture liner & adhesives  Reactions of bone & soft tissues to Implant materials  Conclusion  List of references www.indiandentalacademy.com
  • 7. Biological properties of Dental materials  Biocompatibility = Lack of interaction  Biocompatible material = list of negatives  Non degradable  Non irritant  Non toxic  Non allergic  Non carcinogenic  Non mutagenic  Total inactivity = Passive ignorance ?  More appropriate – active acceptance  Biocompatibility : ability of a material to perform with an appropriate host response, in a specific application. www.indiandentalacademy.com
  • 8. Components  Initial Physiochemical interaction  Effect of the tissue environment  Local host response  Transport of products – Systemic effects  Establishment of solid-liquid interface as any material is implanted into the tissue  Protein absorption is the first event  Immediate response to injury is inflammation  Very few is know about the factors  Condition of the host  Properties of the material  Context in which the material is used Eg: Biocompatible as Crown & Bridge but not as an implant material www.indiandentalacademy.com
  • 9. Adverse effects from Dental materials www.indiandentalacademy.com
  • 10. Toxicity  Placement of a foreign material in the body carries the possibility of toxicity  Toxicity can be of 2 types  Acute toxicity.  Chronic toxicity.  Type 1: requires prolonged or repeated administration  Type 2: requires very few or one dose but long lasting effects  Type 1 chronic toxicity is a possibility with “Biomaterials” Eg: metal ions released by gradual corrosion of an implant  According to J.J.Jacobs et al (1991)  Vanadium – lungs  Aluminium – surrounding tissues  Fortunately, materials causing over toxicity are no longer used in dentistry. www.indiandentalacademy.com
  • 11. Inflammation  May result from toxicity or allergy and often it precedes toxicity.  Oedema, inflammatory cell infiltrate  Current biocompatibility researchwww.indiandentalacademy.com
  • 13. Allergy  Body specifically recognizes material as foreign & reacts disproportional to the amount of material  Gell & Coomb‟s classification of immune responses  Type 1: Atopic or anaphylactic reaction  Type 2: Cytotoxic hypersensitivity reaction  Type 3: Immune complex disease  Type 4: Delayed or cell mediated hypersensitivity  Type 5: Stimulating antibody reaction  Type 6: antibody dependent, cell mediated Cytotoxic reaction www.indiandentalacademy.com
  • 14.  Type 1, 2, 3 – quickly. Eosinophils, Mast cells & B lymphocytes  Type 4 – delayed. Monocytes & T cells  Allergic response – individual‟s immune system recognizes a substance as foreign  Allergic reactions – initially dose independent, disproportionate  Toxic / inflammatory reactions – dose dependant, proportionate www.indiandentalacademy.com
  • 15. Mutagenic reactions  Alteration in base pair sequence (mutation)  2 types  Alteration in cellular process that maintain DNA integrity  Direct interaction  Can occur from radiations, chemicals, errors in DNA replication process  Examples  Metal ions – nickel, copper, beryllium  Few components of root canal sealers  Resin based materials to some extent www.indiandentalacademy.com
  • 16. Carcinogenic response  Currently no dental material has been shown to be carcinogenic for dental applications in patients  However, carcinogenesis is often exceedingly difficult to prove or disprove conclusively www.indiandentalacademy.com
  • 17. Local & Systemic effects of materials  Local effects  Pulp  Periodontium  Root apex  Oral tissues – buccal mucosa, tongue  Systemic effects  Function of the distribution of substances released from the materials  Simple diffusion  Lymphatics  Blood vessels  Access to the body by  Ingestion & absorption in gut  Inhalation  Release at tooth apex  Absorption into mucosa  Systemic response depends on  Duration & concentration of the exposure  Excretion rate of the substance  Site of the exposure www.indiandentalacademy.com
  • 18. Key principles that determine adverse effects from materials  A) various types of metal corrosion & other types of material degradation :  Biocompatibility depends on the degradation process  Corrosion is determined not only by material composition but also by the biological environment  Many ways for release of products in host  Metal prosthesis – releases metal ions by  Electrochemical force  Particles dislodged by mechanical forces  Resin composites  Cyclic stresses  Salivary esterases www.indiandentalacademy.com
  • 19.  B) Surface characteristics :  Surface is quite different from interior  Examples  Dental casting alloy containing 70% gold may have 95% gold at its surface  Relative unpolymerized state of a sealant at its surface  The surface composition, roughness, mechanical & chemical properties are critical to the biocompatibility www.indiandentalacademy.com
  • 21. Concept of Immunotoxicity “ Based on the principle that small alteration in the cells of immune systems by materials can have significant biological consequences ”  Examples:  Mercury ions increase the Glutathione but Palladium decreases Glutathione content of Monocytes  HEMA may change the ability of Monocytes to direct an immune response once challenged by plaque or others agents www.indiandentalacademy.com
  • 22. Oral anatomy that influences the Biological response  Enamel : “seals” the tooth  Peroxides permeate intact enamel  Dentine & Pulp :  Smear layer  Effective in reducing the hydrostatic pressure but not diffusion  Acid etching www.indiandentalacademy.com
  • 23.  Bone : Osseointegration & Biointegration  Osseointegration  Implant & bone closely approximate to each other  Approximation less than 100 A  No fibrous tissue in intervening space  Titanium alloys  Biointegration  Implant & bone are fused to one another & are continuous  Occurs with Ceramic & Ceramic coated metal implants Eg: Calcium & Tri calcium phosphate, Hydroxyapatite, Bioglass www.indiandentalacademy.com
  • 24. Measuring the Biocompatibility  Is not simple and methods of measurement are evolving rapidly as more is know about the interactions between dental materials and oral tissues & as technologies for testing improves  Classified as  In Vitro test  Animal test  Usage test  Clinical trial – special case of a usage test in humans www.indiandentalacademy.com
  • 25. In Vitro test  Placement of a material or component of it in contact with cell, enzyme or some other isolated biological system  Direct  Material in contact  Physically present or extract from material  Indirect  Some sort of barrier www.indiandentalacademy.com
  • 26. Types of cells used in In-vitro assays  Primary cells :  Directly from an animal into culture  Grows for only a limited time  Continuous cells :  Primary cells transformed to allow them to grow indefinitely www.indiandentalacademy.com
  • 27. Testing procedures & extent of testing  Manufacturer‟s responsibility to test new material  A) Initial tests :deals with general biocompatibility & systemic effects of a material  Short term systemic toxicity test  Short time oral administration  Toxicity profile  Acute systemic toxicity test  I.V administration  Inhalation toxicity test  Dental remedies that have significant volatility under usage condition  Hemolysis test  In vitro evaluation of hemolytic activity of materials intended for prolonged tissue contact  Emes mutagenicity & the dominant lethal test  To asses the potential carcinogenic activitywww.indiandentalacademy.com
  • 28. Cytotoxicity tests  Measures cell count or growth after exposure to a material  Method 1 :  Place the cells in the well of a cell culture dish  If Cytotoxic - cell may stop growing, exhibit cytopathic features or detach from the cell  Method 2 :  Measurement of cytotoxicity by a change in membrane permeability  Loss in membrane permeability is equivalent or very nearly equivalent to cell death  Identifies the cells that are alive or dead www.indiandentalacademy.com
  • 29. Tests  Sensitization test  Oral mucous membrane irritation test  Subcutaneous implant test  Bone implant test www.indiandentalacademy.com
  • 30. Usage tests  Pulp &Dentine test  Response of dentine & pulp  Minimum experimental variables  Pulp capping & Pulpotomy test  Endodontic usage test  Assess response of the pulp wound & the periapical tissue  Influenced by – level at which the pulp tissue is cut off & total removal of pulp tissue  Bone implant usage test  To evaluate all materials that, during their intended use, penetrate the oral mucosa and the adjacent bone www.indiandentalacademy.com
  • 31. Correlation among the tests  Lack of correlation  Less prominent biological response  Barriers may exist  Measure different aspects of the biological response to the material www.indiandentalacademy.com
  • 32. Advantages & disadvantages of Biocompatibility tests  In-Vitro test  Advantages  Quick to perform  Least expensive  Standardized  Large scale screening  Excellent for mechanisms of interaction  Disadvantages  Relevance to In-Vivo questionable www.indiandentalacademy.com
  • 33.  In- Vivo test  Advantages  Allows complex systemic interactions  More comprehensive  More relevant  Disadvantages  Relevance to use ?  Expensive  Time consuming  Ethical concern  Difficult to control  Difficult to interpret & quantify www.indiandentalacademy.com
  • 34.  Usage test  Advantages  Relevance to use of material is assured  Disadvantages  Very expensive  Time consuming  Major legal / ethical www.indiandentalacademy.com
  • 35. usage progression secondary of primary testing  Linear paradigm, relies on the accuracy of the primary tests (challenged by Major et al 1977)  No prediction of results in usage tests  Lack of correlation in In-Vitro tests How the tests are used together to measure the Biocompatibility www.indiandentalacademy.com
  • 36.  Non linear thinking U Progression S of P Testing  All the 3 tests are done  As test progresses Usage test predominates www.indiandentalacademy.com
  • 37.  Most common progression Usage „Recognizes Primary Secondary complexity‟ www.indiandentalacademy.com
  • 38. Standards that regulate the measurement of Biocompatibility  ANSI / ADA : earliest attempt in 1933  1972 – The Council on dental material, instruments & equipment of ANSI / ADA approved document no. 41 for recommended standard practices for biological evaluation of dental materials  In 1982 updated to include test for mutagenicity  Uses linear paradigm www.indiandentalacademy.com
  • 39.  ISO Standard 10993 :  Not restricted to dental materials only  First published in 1992  In 2002 ISO 10993 consisted of 16 parts  2 types of tests –  Initial – Cytotoxicity, sensitization & systemic toxicity. In – Vitro / animal test  Supplementary – chronic toxicity, carcinogenicity & bio-degradation. Animals / Humans  Specialized tests – Eg: dentine barrier test www.indiandentalacademy.com
  • 40. Current Biocompatibility issues in dentistry www.indiandentalacademy.com
  • 41.  Reactions of pulp to different materials  Micro leakage :  If a material does not bond or debonds at enamel or dentine  Previous belief  Concept of nano leakage  Between mineralized dentine & bonded material. In very small spaces of demineralized matrix into which material did not penetrate  Hydrolytic degradation of dentine – material bond www.indiandentalacademy.com
  • 42.  Dentine bonding :  Bonding to dentine is difficult – composition, wetness, lo w minerals  Smear layer formation & removal  Many studies have shown  0.5mm of RDT is adequate  Dentine is a buffers of protons  Penetration of acids < 100 micrometers www.indiandentalacademy.com
  • 43.  Dentine bonding agents :  HEMA is 100 times less cytotoxic in tissue culture than Bis – GMA  Bis – GMA, TEGDMA, UDMA www.indiandentalacademy.com
  • 45.  Dental amalgam :  Toxic or not ?  In usage test response of pulp to amalgam in shallow or deep lined cavities  Gallium based amalgam  Excessive gallium release, roughness, discolor  Significant foreign body reaction  Absorption : 1 – 3 micrograms / day  Minimum dose to produce observable toxic effect is 3 micrograms / kg body weight www.indiandentalacademy.com
  • 46.  Dental cements  Resin based materials :  Resin composites – luting or restorative  Light cured < cytotoxic than chemically cured  Pulpal reaction diminishes after 5 – 8 weeks  Protective liner or bonding agent minimizes Pulpal reaction www.indiandentalacademy.com
  • 47.  Glass ionomers :  Luting agent & restorative material  Weaker polyacrylic acid  Fluoride release  Histological studies in usage test shows that any inflammatory infiltrate to ionomer is minimal or absent after 1 month www.indiandentalacademy.com
  • 48.  Zinc phosphate :  Luting agent & base  Thermal conductivity closer to enamel  Pulpal damage in first 3 days due to initial low PH(4.2), reaches neutrality in 48 hours  When placed in deep cavities ?  Inclusion of Ca- OH to the powder or lowering the concentration of phosphoric acid www.indiandentalacademy.com
  • 49.  Calcium hydroxide : Suspension form Resin containing Highly cytotoxic Mild to moderate cytotoxic Necrosis 1mm or > No necrotic zone shortly Neutrophil infiltration Dentine bridge formation 5 to 8 weeks is quick Slight inflammatory response wks - months Dystrophic calcification Dentine bridge www.indiandentalacademy.com
  • 50.  Zinc oxide eugenol :  Suppresses the nerve transmission  Inhibit synthesis of Prostaglandins & Leukotriens  Hammesfahr 1987, initiated the search for a biocompatible resin base system incorporating Calcium hydroxide “ PRISM VLC DYCAL” www.indiandentalacademy.com
  • 51. Soft tissue response to the luting cements  Apply petroleum jelly  Clean the excess  Any residues of cement www.indiandentalacademy.com
  • 52.  Bleaching agents :  Usually contain some form of peroxide  In-Vitro – traverses the dentine & in sufficient conc. can be cytotoxic  Penetrates intact enamel & reaches the pulp in few min.  May burn gingiva www.indiandentalacademy.com
  • 54.  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 www.indiandentalacademy.com
  • 55. Liquid vulcanization solid latex sulphur + heat rubber  Soaked in hot water leaches out allergens  Allergenicity depends on collecting, preservation & processing www.indiandentalacademy.com
  • 57.  Impression materials :  Price & Whitehead (1972) – Allergic contact stomatitis & Foreign body response  Sydiskis & Gerhardt (1993) – some degree of toxicity in cell culture  Gabriela Mazzanti et al (2005) – no significant evidence of diffuse inflammation or local skin reaction www.indiandentalacademy.com
  • 59.  Dental casting alloys :  John c. Wataha 2000  Release of elements is essential for adverse effects  Identifying & quantifying the elements that are released is most relevant measure from stand point of Biocompatibility  a) Release of elements from casting alloys  Multiple phases  Inherent tendency to release elements – lability Eg: Cu, Ni, Cd, Zn & Ga – highly labile  Environmental conditions - PH www.indiandentalacademy.com
  • 60.  b) Systemic toxicity  Released metals may not be inside the body  Route of access – I.V < Peritoneal < Oral  Distribution – there is no documented proof that these material cause „Systemic toxicity‟  c) Local toxicity  Micro environment exists around casting alloys  Metal ions can cause local toxicity  Increased exposure causes increased toxicity www.indiandentalacademy.com
  • 61.  d) Allergy to dental casting alloys  Elemental release is essential for allergy  Metal ions – Haptens  Allergy & Toxic reaction – difficult to distinguish www.indiandentalacademy.com
  • 62.  Patch test for metals – controversial  Application of metal ion to skin in the form of patch  Injecting small amount of ion below the skin  Assessment of the response is difficult  Salt of metal ions important for response Eg: chloride, sulphate, nitrate salts  Vehicle – whether its water, oil or petrolatum can vary the response  Grimaudo N.J 2001 – true allergic hypersensitivity to dental casting alloys is rare www.indiandentalacademy.com
  • 63.  Nickel :  Common component  Incidence of allergy 10% – 20%  Cross reactivity between nickel & palladium (33% & 100%)  Nickel ions induces ICAM‟s in the endothelium – release of cytokines  It may contribute to any intraoral inflammation around nickel containing crowns www.indiandentalacademy.com
  • 64.  Beryllium :  Used in Ni-Cr alloys in conc. of 1 – 2 wt%  Forms thin adherent oxides  Documented carcinogen  Berylliosis  Individual is hypersensitive  Inhalation of beryllium dust, salts, fumes www.indiandentalacademy.com
  • 65. Reaction of other oral soft tissues  a) Denture base materials  Methacrylates  Greatest potential for hyper sensitization  Acrylic & diacrylic monomers, curing agents, antioxidants, ami nes, formaldehydes  For the patients most of these materials have been reacted in polymerization and thus less prone www.indiandentalacademy.com
  • 66.  True allergy of oral mucosa to denture base material is very rare  Residual monomer (methyl methacrylate)  Allergic acrylic stomatitis  Heat cured is better www.indiandentalacademy.com
  • 67.  b) Soft denture liners & adhesives  Release of plasticizers  Extremely cytotoxic  Effects are masked by the inflammation  Denture adhesives show severe cytotoxic reactions In-Vitro  Large amount of formaldehyde  Allowed significant microbial growth www.indiandentalacademy.com
  • 68. Denture cleansers  Used to cleanse the prosthesis  Eg : Hypochlorite, mild acids, etc.  Biocompatible & cause no harm to the patient www.indiandentalacademy.com
  • 69. Artificial teeth  Acrylic & Porcelain teeth  Acrylic teeth is preferred in poor ridges www.indiandentalacademy.com
  • 71. Reaction of bone & soft tissues to implant material  Materials – Ceramics, Metals, Carbons & Polymers  a) Reaction to ceramic implant material  Very low toxic effects. Oxidized state, corrosion resistant  Used as a porous or dense coating  Root surface porosities > 100microns (firmly bound )  Root surface porosities < 100microns (fibrous ingrowth)  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 www.indiandentalacademy.com
  • 72.  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 www.indiandentalacademy.com
  • 73.  Soft tissue :  Epithelium forms 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 www.indiandentalacademy.com
  • 75. List of references  Restorative dental materials by Craig & Powers  Phillips‟ Science of dental materials  Chemistry of medical & dental materials by J.W.Nicholson  Concise Encyclopedia of medical & dental materials by David Williams  Dental biomaterials by Arturo N. Natali  Dent material 2005;21(4):371-74  JPD 2001 Aug;86(2):203-9  Gen Dent 2001 Sep-Oct;49(5):498-503  JPD 2000 Feb;83(2):223-34  JPD 1998 Sep;80(2):203-9  JPD 1993;69;431-5  J Biomater Appl 1987 Jan;1(3):373-81  BDJ 1972;133:9-14 www.indiandentalacademy.com
  • 77. Precautions to be taken in the Lab  Make certain the ventilation system in room is properly functioning  During operation of the dental lathe wear a protective eyewear & a mask  Clean & disinfect the dental lathe at least once daily  Use sterile rag wheels, stones & fresh pumice for each patient's prosthesis www.indiandentalacademy.com
  • 78. www.indiandentalacademy.com Thank you For more details please visit www.indiandentalacademy.com