Professional Documents
Culture Documents
Biocompatibility of Dental Amterials
Biocompatibility of Dental Amterials
Biocompatibility of Dental Amterials
1
BIOCOMPATIBILITY
OF DENTAL
MATERIALS
2
contents
Introduction
Historical Background
Health Effects
Key Principles That Determine Adverse
Effects From Materials
Determination Of Biocompatibility
Strategies For Evaluating
Biocompatibility
Regulations And Standards
3
contents
Biocompatibility Of Various Dental Materials
Resin Based Composites
Cements and Ceramics
Dental Alloys
Oral Hygiene Products
Impression Materials
Barrier Materials( Gloves & Mouth Masks)
Methyl methacrylate
Diagnostic tests on patients
Conclusion
References
4
INTRODUCTION
5
DEFINITIONS
It is the ability of a material to elicit
an appropriate biological response in a
given application in
the body.
WILLIAM D,F 1987
The term biocompatible is defined as
being harmonious with life and not
having toxic or injurious effects on
biologic function.
DORLAND’S ILLUSTRATED MEDICAL
DICTIONARY
6
HISTORICAL BACKGROUND
• Concept of ethical treatment of
patients extends back to the time of
Hippocrates (460 – 377 B. C.)
8
Adverse effects from dental
materials
0.1%
Among dental personnel 40- 50%
•Toxicity
•Inflammation
•Allergy
•Mutagenic &carcinogenic reactions
9
TOXICITY
ACUTE
SUBACUTE
CHRONIC
Type 1: requires prolonged or repeated
administration
Type 2: requires very few or one dose
but long lasting effect
Type 1 chronic toxicity is a possibility with
“Biomaterials”
Eg: metal ions released by gradual corrosion of
an implant
11
LOCAL TOXICITY
Substances released from dental materials –cell metabolism-
Inflammation or necrosis
Accumulation of bacteria
Mechanical/physical irritation
12
(Chronic local irritative
reaction) Exacerbation of a
Buccal mucosa lichen lesion in
contact with a corroded amalgam
restoration
13
Inflammation
Inflammatory response is complex but involves the activation of
host’s immune system to ward off some threat
May result from toxicity or allergy and often it precedes toxicity.
Edema, inflammatory cell infiltrate
Current biocompatibility research …materials contribute to
inflammation even if no toxicity is evident.
14
Allergy
15
ALLERGY
Body specifically recognizes a material as foreign
& reacts disproportional to the amount of material
17
ALLERGIES
Dental materials ..
Type I (immediate reaction)
type IV (delayed reaction)
18
IMMEDIATE ALLERGIC
REACTIONS (IgE mediated)
An immediate allergic reaction occurs when an allergen
enters the circulation by ingestion or parenteral routes
,localizes in a target tissue (e.g. in the oral cavity), and
binds with IgE mast cell complexes, which release
histamine.
Oral vesiculo-ulcerative lesions
Urticaria
Angioedema
Anaphylactic shock 19
ANGIOEDEMA
20
Contact Urticaria
Occupational exposure to
latex proteins in
disposable gloves
21
DELAYED ALLERGIC
REACTIONS (Cell mediated)
Specific sensitized T
lymphocytes, which react with
the allergen and release
lymphokines, eliciting an
inflammatory reaction.
23
DELAYED ALLERGIC
REACTIONS (Cell mediated)
24
DELAYED ALLERGIC
REACTIONS (Cell mediated)
Erythematous contact
lesion adjacent to 23
and 24
25
OTHER REACTIONS
Mutagenicity
2 types
Alteration in cellular process that
maintain DNA integrity
Direct interaction
26
Carcinogenic response
Currently no dental material has
been shown to be carcinogenic for
dental applications in patients
27
KEY PRINCIPLES THAT
DETERMINE ADVERSE EFFECTS
FROM MATERIALS
METAL Composition
CORROSION Biological environment
OR MATERIAL
Salivary Esterases- dental resins
DEGRADATION
Ingestion of acidic substances-
corrosion of alloys and ceramics
28
Concept of
Immunotoxicity
29
Concept of Immunotoxicity
“small alteration in the cells of immune systems
by materials can have significant biological
consequences “
Eg:
Hg ions increase the Glutathione but Pd ions
decreases Glutathione content of Monocytes
HEMA may change the ability of Monocytes to
direct an immune response once challenged by
plaque or others agents
30
EVALUATION OF
BIOCOMPATIBILITY
Alloy
Pulpal compatibility
Allergic potency
31
BASIC TYPE OF TESTS
In Vitro Test
In Animal Test
Usage Test/
Clinical trials
32
IN VITRO TEST
• Test tube, cell culture dish, flask,or
other container
• Material or an extract of a material is
placed into contact with some biological
system
Eg:Mammalian cells, cellular organelles,
tissues, bacteria, or some sort of enzyme
• Direct or indirect
33
Types of in vitro tests
Cytotoxicity or
cell growth
Metabolic and
other cell function
Effect on the
genetic material
34
Tests for Cytotoxicity
Cells are placed in a well of a cell culture dish where
they attach… material is then placed…
35
Tests for cell metabolism or cell function:-
• MTT test.
36
Effect on the genetic material
• Ame’s test:
• Mutant salmonella typhimurium
…exogenous Histidine. Native stocks of
bacteria do not require exogenous
Histidine.
38
IN VITRO TEST
ADVANTAGES
•Quick to perform
•Least expensive
•Can be standardized
•Large scale screening
•Good experimental control
39
IN VITRO TEST
DISADVANTAGES
•Questionable relevance to
the final in vivo use of the
material
•Lack of inflammatory or
other tissue protective
mechanisms in the in vitro
environment
40
IN ANIMAL TEST
Mammals
41
ANIMAL TEST
• Types:-
• Mucous membrane irritation test
• Skin- sensitization test
• Implantation test
42
Mucous membrane irritation test
• Placing the test materials and
positive and negative controls into
contact with rabbit oral tissue.
43
Skin- sensitization test
44
Implantation tests
• Materials are implanted s.c, i.m or in
the bone of an experimental animals
45
IN ANIMAL TEST
ADVANTAGES
46
IN ANIMAL TEST
DISADVANTAGES
47
IN USAGE TEST
LARGER ANIMALS or IN HUMAN VOLUNTEERS
48
Mucosa and Gingival usage tests
• Materials are placed with subgingival
extensions.
• Disadvantages:
– preexisting inflammation in the gingival
tissue
– surface roughness of the restorative
material
– overcontouring and undercontouring of
the restoration.
49
Intraosseous implant test
• Materials used for dental implants are
inserted into the jaw of the test animals.
50
IN USAGE TEST
ADVANTAGES
• Relevance to the use of
material is assured
DISADVANTAGES
•Very Expensive
•VeryTime consuming
•Major Legal/ethical concerns
•Can be Difficult to control
•Difficult to interpret and quantify
51
STRATEGIES FOR EVALUATING
BIOCOMPATIBILITY
Progress
of Usage
Usage
testing
test
test
•Most efficient
•Cost effective Primary test
Primary test
Number of tests
52
Primary tests
• Performed initially in testing of new material
To measure
• Cytotoxicity,
• mutagenecity,
• systemic toxicity
53
Secondary tests
• Usually conducted in animals
To measure
• Chronic toxicity,Inflammation & Allergy
• Sophisticated invitro tests like tests for
estrogenecity,surface effects & osteoinduction are
secondary in nature.
• Usage tests
• Material is tested in clinically relevant situation
54
• Mjor et al (1977)
compared this linear paradigm used in
dentistry..concluded .. Invitro ,animal tests need not
necessarily predict the results of usage tests
• Poor correlation among these tests.
• Relies heavily on the accuracy of the primary tests
• Too severe – good materials will be screened out
• Too insensitive – wasting time, money and placing
animals or humans at Unnecessary risk
55
Newer schemes for the
progression
ATERNATIVE PARADIGMS
56
• Common progression is
from primary to
Usage secondary to usage tests,
• But any test may be
performed at any time in
Primary Secondary the development of a
material, depending on
problems that are
encountered.
57
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
58
• A multiplicity of laws,
standards and Laws
recommendations regulate Standards
Recommendations
the marketing of medical
devices, generating the
impression that dentist can
exclusively rely on them( eg.
CE Labeling).
59
REGULATIONS & STANDARDS
• Safety data sheets.
• safety labels on the
wrappings
.
60
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)
61
• 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.
62
Biocompatibility Of Various
Dental Materials
63
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.
64
Resin based materials :
65
Extraoral allergic reactions
(type I) after application of a
pit and fissure sealant
66
Chemical burn after
inadvertent contact of
phosphoric acid with
gingiva
Gingivitis adjacent to
a cervical composite
resin filling
67
Light curing units
• Hazardous to eyes
• Afterimages( Reversible)
• Photochemical damages(loss of
acuity)(irreversible)
• Protective glasses/ protective shields
68
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
69
Zinc phosphate cement
that was left in the sulcus
after cementation results
in periodontal destruction.
70
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.
71
Calcium Hydroxide Cement
Suspension form Resin containing
72
Zinc Oxide Eugenol Cement
Max Eugenol release- within first 5
hour(4-5%)
Antimicrobial properties against a
great variety of bacteria
73
Precautions during cementation
74
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.
77
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.
78
gingivitis due to the PFM
crowns;
79
Gold coating of nickel-
based and cobalt-based
alloys.
80
Perioral allergic reaction
after insertion of nickel-
containing orthodontic wires
(CuNiTi)
Lichenoid reaction of
the mucosa contacting an
alloy
81
Pronounced gingivitis after
seating of ceramic crowns,
despite good oral hygiene
82
DIAGNOSTIC TESTS ON
PATIENT
Allergy tests:
83
Analysis of Intraoral alloys
• CHIP TEST
• To know the composition of alloy
a) Collection of alloy particles/chips.
b) Alloy chips attached to self-
adhesive graphite disk.
C) Scanning electron microscopic
image of an alloy chip.
d) Results of energy dispersive x-ray
analysis; 84
Analysis of metals in saliva and
biopsies
85
ORAL HYGIENE
PRODUCTS
Toothpastes & Mouthwashes
Alcohol
Fluorides
Abrasives
Chlorhexidine
.Allergens are
Flavoring Agents – cinnamon, peppermint, spearmint
Chlorhexidine
Others – acetamide, azulene, benzoates, Choroacetamide, propolis.
86
ORAL HYGIENE
PRODUCTS
Mechanical abrasion of
tooth substance
87
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
88
TOOTH BLEACHING
AGENTS
89
Impression materials
90
Impression materials
Silicones – A & C
Polyether
Polysulphides
Hydrocolloids
Alginate
ZnOE
91
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
92
Fatal Anaphylactic Shock Due to
a Dental Impression Material
Gangemi et al
• Department of Human Pathology.
University of Messina. Italy .
93
• A 75-year-old man with diabetes, cardiopathy, and chronic
bronchitis underwent a dental impression for a new denture
94
One hour later, the patient suddenly
worsened. He was again treated with 4 mg
of iv betamethasone and underwent a
tracheotomy.
95
Discussion
• The cause of death was heart
failure, an acute myocardial
insufficiency with the involvement
of several other pathologic factors.
96
• The safety data sheet reports that the
product has not had any hazardous reactions,
nor does it have any hazardous decomposition
products
97
Latex
98
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
99
Liquid vulcanization solid
latex sulphur + heat rubber
100
BARRIER MATERIALS
•Contact urticaria following
occupational exposure to
latex proteins in disposable
gloves
101
POLYMETHYLMETHACRYLATE
RESINS
a) Denture base materials
Methacrylates -Greatest potential
for hyper sensitization
Acrylic & diacrylic monomers, curing
agents, antioxidants, amines,
formaldehydes
For the patients most of these
materials have been reacted in
polymerization and thus less prone
102
True allergy of oral mucosa to denture base
material is very rare
Residual monomer (methyl methacrylate) is
believed to be responsible for allergic reactions
in susceptible patients
Allergic acrylic stomatitis – diffuse erythema,
edema & occasionally small vesicles and erosions
Heat cured is better
103
Dentist suffering from an
allergy to methyl
methacrylate contact
dermatitis
Pronounced inflammation
of the palatal mucosa
beneath a polymethyl
methacrylate denture
with papillary hyperplasia
104
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
105
Denture cleansers
Used to cleanse the prosthesis
Eg : Hypochlorite, mild acids, etc.
Biocompatible & cause no harm to the
patient
106
Artificial teeth
107
Implants
108
Reaction of bone & soft tissues
to implant material
Materials – Ceramics, Metals, & Polymers
b) Hydroxyapatite
Relatively non resorbable form of calcium phosphate
Coating material & ridge augmentation material
109
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
110
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
111
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.
112
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)
113
Thank you