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BIOKOMPATIBILITAS

DENTAL MATERIALS
Dr Drg DIYAH FATMASARI MDSc

Definisi:
Bio: jaringan hidup
Kompatibel: cocok/sesuai
Dapat menyesuaikan diri
dengan jaringan hidup
yang berhubungan dengan
material

BIOKOMPATIBILITAS

Semua bahan /sediaan yang berkontak langsung
…..dengan tubuh manusia …..melalui suatu uji biologis
atau juga disebut dengan uji biokompatibilitas.

Definisi:
 Kemampuan bahan untuk bereaksi sesuai dengan
fungsi …..pengobatan ….tdk menimbulkan pengaruh
lokal maupun sistemik terhadap jaringan tubuh
…..dapat meningkatkan kesesuaian bahan dengan
jaringan selular pada situasi khusus dan
mengoptimalkan fungsi bahan secara klinis (William,
2008a; William, 2008b).

1.
2.
3.
4.

BAHAN KG KONTAK LANGSUNG DNG JARINGAN
HIDUP (BIOMATERIAL)
KOMPOSIT
POLIMER
LOGAM
KERAMIK

SIFAT MEKANIS, FISIK, KIMIAWI, BIOLOGIS
Sifat biologis adalah sifat yang berhubungan
langsung dengan reaksi bahan dengan jaringan
hidup (Anusavice, 2009).

BIOKOMPATIBILITAS
Melibatkan 3 faktor:
1.
2.
3.

Reaksi pasien
Fungsi bahan
Sifat bahan

Syarat biokompatibilitas bahan
kedokteran gigi
1. Tidak membahayakan pulpa dan jaringan
lunak.
2. Tidak mengandung bahan toksik yang
dapat berdifusi, terlepas dan diabsorbsi
dalam sistem sirkulasi.
3. Bebas dari agent yang dapat
menyebabkan reaksi alergi.
4. Tidak berpotensi sebagai bahan
karsinogenik.

Klasifikasi bahan berdasarkan
kontak dengan jaringan hidup
Anusavice (2009) :
1. bagian luar tubuh manusia (kulit, mokosa
membran, beberapa permukaan tubuh);
2. bagian dalam tubuh (ujung pembuluh
darah, tulang, dentin, jaringan lunak,
sistem sirkulasi darah);
3. tertanam di dalam tubuh (implan).

Evaluasi biokompatibilitas
Ferracane (2001)
1. Uji Primer…. bahan langsung diuji dengan
biakan sel jaringan… IN VITRO
2. Uji Sekunder…. bahan diuji potensi dalam
sensitivitas, alergi dan toksisitas sistemik…
IN VIVO
3. sebelum bahan dilemparkan ke pasaran
binatang coba atau primata yang lebih besar
sebagai subyek uji dengan keadaan serupa
dengan keadaan aplikatifnya pada manusia

Manfaat evaluasi bahan:
Bahan kedokteran gigi tidak boleh
mengandung material yang berbahaya,
dapat lepas atau dapat terserap oleh sistem
sirkulasi tubuh, bebas dari agen yang
menyebabkan sensitif atau alergi atau
memberikan reaksi lokal dan sistemik
(Kasten dkk., 1989).
Keselamatan pasien, operator serta untuk
membuat suatu regulasi/aturan kesehatan

Pertimbangan sebelum release
produk/bahan
 Bahan

dari pabrik sdh di uji apa belum
 Adanya tambahan bahan aditif, proses
kontaminasi dan zat sisa/residu ada saat
pembuatan
 Apakah ada bahan yang larut
 Degradasi produk
 Sifat dari sediaan/bahan

THE RANGE POTENTIAL BIOLOGICAL HAZARD:
Short-term effect
- acute toxicity, irritation (to the skin, eye,
mucosal surface), sensitization, haemolysis,
thrombogeni- city.
 Long-term effect
- subchronic & chronic toxic effect, sensitization,
genotoxicity, carcinogenicity and effect on
reproduction

Standard & Testing
Physical & chemical properties
Specification
Clinical studies
Clinical uses
Biological test
(primary, secondary, usage test)
The selecting materials use of

Biological standardization testing materials
Safety
Effectiveness
Risk classification
Class I : low risk
Class II: must safety the requirement
Class III: full safety & efficiency assessment

Report side effect of medical disease
(system for individual/field)
Record system
Data base
The types of regulating cation in the future
(low occurs)

Safety evaluation
Control
Difficult
Information qualitative & quantitative
Meager
(sangat kecil)

Questionaire

Don’t provide objective
 Varying ability to observe
Evaluate & clearly describe symptom
 Symptom by factor the treatment
Safety information

Epidemiological studies
(systematic, cross sectional, longitudinal)

Don’t provide objective may be :
Side effect : - to be rare or mild
- relative biocompatility
 Approach :
- evaluate in dental patient
- retrospective dentist record

depend on :
- chemical composition
- degradation product
- absorption accumulation
- leachable

Advantages and Disadvantages

In vitro test
Advantages: - quick to perform
- lest expensive
- can be standardized
- large scale screening
- good experiment control
- good excellence for mechanism
of interaction
Disadvantages : relevance to in vivo is
questionable

In vivo test :
Advantages:
- allows complex systemic interaction
- response more comprehensive
- more relevant
Disadvantages:
- relevance to use of materials questionable
- time consuming
- legal / ethical concerns
- difficult to control
- difficult to interpret and quantity

Usage test
Advantages :
- relevance to use of material is assured
Disadvantages:
- very expensive
- very time consuming
- major legal/ethical issue
- can be difficult to control
- difficult to interpret and quantity

Standard that regulate the
measurement of biocompatible
The reason

The vast advance of cellular & molecular
biology
 The variety of test available for assessing
biocompatibility of material
 The lack of standardization of these test

ADA Specification 41
3 category of test (1982):
- initial test …in vitro
- secondary test….in vivo
- usage test :
a. placement of the materials in
intended
b. first in larger animal / primates
c. Food & drug Administration approval

Recommended Levels of Biologic
Testing
(ADA)

Initials Tests
- Short term systemic toxicity test: Oral route
- Acute systemic toxicity test: Intravenous
route
- Inhalation toxicity test
- Hemolysis test
- Ames mutagenicity test
- Styles cell transformation test
- Dominant lethal test (LD50)
- In vitro cytotoxicity test (Cr release)
- Cytotoxicity test (Millipore filter)
- Tissue culture agar overlay test

Secondary Tests
- Subcutaneous implant test
- Bone Implant
- Sensitization test
- Oral mucous membrane irritation test
 Usage Test
- Oral mucous membrane irritation test
- Pulp and dentin test
- Pulp capping and pulpotomy test
- Endodontic usage test
- Bone implant usage test

Cytotoxicity Test

The use of cell culture technique
 Determine the lysis or death of cell, inhibition of
cell growth
 Other effect on cell caused by medical device,
materials and or their extract

Sensitization Test

These tests estimate
 Using an appropriate model
 The potential of: medical device, materials
and or extracts for contact sensitization
 Are appropriate because exposure or contact
to even minute amounts of potential
leachable can result in allergic or
sensitization reactions

Irritation Test

These tests estimate the irritation potential of
medical devices, material and or extracts
 Using appropriate sites for implant tissue in
suitable model
 Performed should be appropriate for the route
and duration of exposure or contact for determine
irritant effect

Systemic Toxicity (Acute Toxicity)

These tests estimate the potential harmful effect
of single or multiple exposure
 A period of less than 24 hour to medical device,
material and or extracts in an animal model
 Are appropriate where contact allows potential
absorption of toxic leachable and degradation
product

Attachment between metal and
tissue
Diffusion oxygen and metals ion into tissue
 Diffusion hydrogen and oxygen into tissue
to form hydroxides
 Diffusion of mineral or atoms from
electrolyte in to the oxides
 Dissolution of oxide metal ion (corrosion)
 Adsorption at biomolecular
 Desorption for replacement of biomolecular
 Fragmentation of modification of
biomolecular

Processing to improve biocompatibility

Sterilization
 Steam Sterilization
(autoclave)
 Ethylene Oxide Sterilization
(EtO)
 Radiation Sterilization
- gamma X-ray
- electron beam

1. Anusavice KJ, 2009, Phillips Buku Ajar
Ilmu Bahan Kedokteran Gigi, EGC
2. Williams DF, 2008a, On the Mechanisms
of Biocompatibility, Biomaterial Vol 29
3.Williams DF, 2008b, Dorland’s Medical
dictionary, Biomaterial Vol 29
4. Ferracane JL, 2001, Materials Dentistry,
Principles and Application, 2nd edition,
Lippincott Williams & Williams, Philadelpia
5. Kasten FH, Pineda LF, Schneider PE,
Rawls HR, Foster TA, 1989, Biocompatibility
testing of an experimental fluoride
releasing resin using human gingival
ephitelial cells in vitro, In Vitro Cellular &
Developmental Biology 25 (1)

terima kasih
Wassalamu ‘alaikum wr wrb