Matters: Biological Properties

Dr. Deby Fajar Mardhian

d.fajar.mardhian@unpad.ac.id

Dept. of Dental Materials

Unpad Dentistry
 Objectives

Students acknowledge the importance of biocompatibility in biomaterials.

Students learn the effect of certain matters and the response of biological system.

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 Content

Biocompatibility

Adverse effects

Tests hierarchy

In vitro tests

In vivo tests

Usage and clinical tests

Standardization

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 Biocompatibility

Ability of material to adapt to response upon wearing in biological system. (Craig)

Ability of material to adapt to response from biological host. (Schmalz)

Biocompatibility is not always inert.

Biocompatibility is not only the inner property of material, but also how it reacts with the
biological environment.

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 Biocompatibility

“The ability of a biomaterial to perform its desired function with respect to a

medical (or dental) therapy, without eliciting any undesirable local or systemic
effects in the recipient or beneficiary of that therapy, but generating the most
appropriate beneficial cellular or tissue response in that specific situation, and
optimizing the clinically relevant performance of that therapy”.

Williams (2008)

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 Basic concept of biocompatibility

Biomaterials in dentistry can exhibit effect, either directly or systemically through different
pathways.

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 Effects of materials on biological system (and health)

Systemic toxicity

Local reaction

Allergic reaction

Other reaction

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 Systemic toxicity

Almost all dental materials are used in oral cavity and may be inhaled by respiration
system.

What happen upon further use?

Systemic toxicity is divided into 3 categories:

 Accute (within 24 hours)
 Sub-acute (within 3 months)
 Chronics

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 Local reaction

Chips of materials on the surface (debris, etc) can lead to

local reaction, inflammation, or necrotic tissue.

Bacterial accumulation can also enhance the local reaction,

in addition to physical irritation.

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 Allergic reaction

Allergic reaction can be induced by the sensitivity of

host.
Four classification of allergic reaction: type I, II, and III
are caused by antibody while type IV is caused by
cellular reaction.
Type I is immediate, type IV is delayed reaction.

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 Other reactions

 Mutagenic, carcinogenic, …

 Changes in DNA genome (genotoxicity)

 Used as theoretical knowledge and will not be found in commercialized biomaterials.

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 How to examine biocompatibility?

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 Tests hierarchy

 In vitro (primary) tests

 In vivo (animal, secondary) tests

 Usage (clinical) tests

Classical progression of biocompatibility tests

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 Tests hierarchy

Newer schemes for progression of biocompatibility tests

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 In vitro tests (primary)

Direct tests Indirect tests

Material is tested in a direct contact fashion Material is tested in a indirectly with sort of
with the biological system without barrier. barrier between material and biological system.
E.g. zone of inhibition test E.g. dentin barrier test

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 Cell culture
Tibia & femur
bone 4 days pre-cultured 6 days cultured
marrow

4 weeks male SD rat

Cell was seed on

the samples
Density
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4104 cells/cm2 16
 Cell morphology

HAp N2 CO2

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 Tartrate-resistant acid phosphate (TRAP)

Plastic

HAp

N2

CO2

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 In vivo tests (secondary)

Mice Rats Hamsters Guinea pigs

 More relevant to actual condition (closer to clinical setting)
 More difficult to interpret
 Costly, time-consuming, needs ethical clearance.

E.g. mucous membrane irritation test, skin sensitization test, implantation test.

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 In vivo tests (secondary)

Allergy test on a guinea pig

shows redness on the back

Skin is typical site for

allergenic material tests

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 Implant protocol in in vivo setting

Surgical protocols for animal study: (a) intraperitoneal injection of anesthesia, (b) after shaving of fur, disinfection of
surgical area, (c) injection of local anesthesia, (d) incision on skin and periosteum, (e) after bone exposure, drilling to
bone defect, (f) obtained bone defect, (g) implantation of specimen, (h) suturing the skin.

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 Implant results

Histology from rat implanted with carbonate apatite after 6 months.

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 Usage tests

 This type of test may involve both humans and animals.

 Usage tests in animal is different from in vivo test due to its specificities such as
application sites (must be closely relevant to the clinical application)
 This test can predict biocompatibility and project the result of test closely to the clinical
application, that comprises time, site/location, environment, and usage techniques.

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 Standardization
SELAMA RATUSAN TAHUN MATERIAL
KEDOKTERAN GIGI HANYA DIPERHATIKAN SIFAT
FISIKA DAN KIMIANYA
KEAMANANNYA PADA MANUSIA BARU MULAI
DIPERHATIKAN TAHUN 70-AN
(Anusavice, 2003)

MENJADI BAGIAN DARI STANDARDISASI

ANSI/ADA DOCUMENT No. 41 : Biological testing of dental

CE
materials (1972)
ISO 10993 : Testing the biocompatibility of materials (1992)
diadaptasi di Amerika menjadi FDA Blue Book Memorandum
#G95-1
(Anusavice, 2003)

BIOKOMPATIBILITAS
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 Standardized products

… and many more.

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 Minimizing adverse effects

How to minimize side effects or risks in using

biomaterials?
 Determine the use of material (indication and contra).
 Identify main component of the material.
 Evaluate the safety of the material.
 Compare PROS & CONS.
 Anamnesis.
 Plan the treatment precisely.
 Inform the risks (if there is any).

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 References

Phillips’Science of Dental Materials. 13th edition.

Craig’s Restorative Dental Materials. 13th edition.
Dental Materials in Operative Dentistry. 5th edition.
Materials Science for Dentistry. 9th edition.
Restorative Dentistry An Integrated Approach. 2nd edition.
Science of Dental Materials Clinical Applications. 2nd edition.
Textbook of Dental Materials.
Textbook of Operative Dentistry.
…
…
and many others.

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 Discussion

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