BIOKOMPATIBILITAS DENTAL MATERIALS

Dr Drg DIYAH FATMASARI MDSc

Definisi:Bio: jaringan hidupKompatibel: cocok/sesuai

Dapat menyesuaikan diri dengan jaringan hidup yang berhubungan dengan material

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).

BIOKOMPATIBILITAS

BAHAN KG KONTAK LANGSUNG DNG JARINGAN HIDUP (BIOMATERIAL)

1. KOMPOSIT2. POLIMER3. LOGAM4. KERAMIK

SIFAT MEKANIS, FISIK, KIMIAWI, BIOLOGIS

Sifat biologis adalah sifat yang berhubungan langsung dengan reaksi bahan dengan jaringan hidup (Anusavice, 2009).

Melibatkan 3 faktor:

1. Reaksi pasien2. Fungsi bahan3. Sifat bahan

BIOKOMPATIBILITAS

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.

Syarat biokompatibilitas bahan kedokteran gigi

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).

Klasifikasi bahan berdasarkan kontak dengan jaringan hidup

Ferracane (2001) 1. Uji Primer…. bahan langsung diuji dengan

biakan sel jaringan… IN VITRO2. 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

Evaluasi biokompatibilitas

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

Manfaat evaluasi bahan:

Bahan dari pabrik sdh di uji apa belumAdanya tambahan bahan aditif, proses

kontaminasi dan zat sisa/residu ada saat pembuatan

Apakah ada bahan yang larut Degradasi produkSifat dari sediaan/bahan

Pertimbangan sebelum release produk/bahan

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

THE RANGE POTENTIAL BIOLOGICAL HAZARD:

Standard & Testing

Physical & chemical properties

SpecificationClinical studies

Clinical uses

Biological test(primary, secondary, usage test)

The selecting materials use of

Biological standardization testing materials

Safety

Effectiveness

Risk classificationClass I : low risk

Class II: must safety the requirementClass 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

DifficultInformation 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)

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

Don’t provide objective may be :

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

Advantages and Disadvantages

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

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

Standard that regulate the measurement of biocompatible

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

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

Recommended Levels of Biologic Testing(ADA)

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

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

Cytotoxicity 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

Sensitization 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

Irritation Test

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

Systemic Toxicity (Acute Toxicity)

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

Attachment between metal and tissue

Steam Sterilization (autoclave)

Ethylene Oxide Sterilization (EtO)

Radiation Sterilization - gamma X-ray - electron beam

Processing to improve biocompatibility

Sterilization

1. Anusavice KJ, 2009, Phillips Buku Ajar Ilmu Bahan Kedokteran Gigi, EGC2. Williams DF, 2008a, On the Mechanisms of Biocompatibility, Biomaterial Vol 29 3.Williams DF, 2008b, Dorland’s Medical dictionary, Biomaterial Vol 294. Ferracane JL, 2001, Materials Dentistry, Principles and Application, 2nd edition, Lippincott Williams & Williams, Philadelpia5. 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

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