Dentistry, Animal Biocompatibility test, introduction, history , significance, types, why animals, conclusion, reference.

1. ANIMAL BIOCOMPATABILITY
TEST
Dr. Vigneshwar T
I M.D.S

2. BIOCOMPATIBILITY
The ability of a material to elicit an appropriate
biological response in a given application in the body
………Craig

3. BIOCOMPATIBILITY
HISTORY
A. Late 1800s - first time - patients mouth
B. GV black
C. 1960s - Current philosophy about testing biological
properties

4. BIOCOMPATIBILITY
HISTORY NAZI HUMAN EXPERIMENTATION
SERIES OF MEDCAL
EXPERIMENT
JEWS AND ACROSS
EUROPE
PRISINORS

5. BIOCOMPATIBILITY
STANDARDS THAT REGULATES ……..
A. 1926 - First ADA establishment of guideline for Dental Material - the National
Bereau of Standard
B. 1933 - Dixon and Rickert - uniform test for all material
C. 1958 - Massler - test on tooth pulp
D. 1959 - Mitchell - test on connective tissue
F. 1972 - ADA Council on DM, instruments and Equipments approved
Specification no 41 for Recommended Standard Practice for Biological
evaluation of DM
HISTORY

6. BIOCOMPATIBILITY
HISTORY ISO 10993
ISO 7405 : 1997
Pre clinical evaluation of Biocompatibility
of medical devices used in dentistry
ISO 10993-2 Animal welfare requirements

7. BIOCOMPATIBILITY
HISTORY ISO 10993
ISO 7405 : 1997
Pre clinical evaluation of Biocompatibility
of medical devices used in dentistry
ANSI/ADA
SPECIFICATION
41-1979
Revised to conform to the ISO standards
Reaffirmed - 2001
ISO 10993-2 Animal welfare requirements

8. BIOCOMPATIBILITY
No of Test
Progress of
testing
HISTORY

9. BIOCOMPATIBILITY
No of Test
Progress of
testing
Usage
Secondary
Primary
ANSI/ADA SPECIFICATION 41HISTORY

10. BIOCOMPATIBILITY
Single material may not be biologically acceptable in all
situations.
Biocompatibility is Dependant on
Biological
Responce
Physical
Function

11. BIOCOMPATIBILITY
change
in
biological
response occurs
when change occurs in
Material
itself
Application
of Material
Host

12. BIOCOMPATIBILITY
DEFINING
THE
USE OF MATERIAL

14. •

15. BIOCOMPATIBILITY
Consideration for Development of Dental Material :
Strength
Aesthetics
Aspects of Material
Biocompatibility

16. BIOCOMPATIBILITY

17. BIOCOMPATIBILITY
IN VITRO TEST

18. BIOCOMPATIBILITY
IN VITRO TEST
ANIMAL TEST

19. BIOCOMPATIBILITY
IN VITRO TEST
ANIMAL TEST
USAGE TEST

20. ANIMAL BIOCOMPATIBILITY TEST

21. WHY ANIMALS ?????
To determine the safety of the medical product
how much of a drug or biologic is absorbed into the
blood
how a medical product is broken down chemically
in the body
the toxicity of the product and its breakdown
components (metabolites)
how quickly the product and its metabolites are
excreted from the body
.

22. ANIMAL BIOCOMPATIBILITY TEST
ADVANTAGE A. More Comprehensive
B. More Relavant
DISADVANTAGE A. Difficult to interpret/control
B. Expensive
C. Time Consuming
D. Ethical Concern
E. Paperwork

23. contact and test site are
examined
- control+ control
Test Material
contact
few weeks
MUCOUS MEMBRANE IRRITATION TEST

24. WHAT DOES IT CHECK ?

25. Test material
SKIN SENSITISATION TEST

26. Test material
Why this
test
SKIN SENSITISATION TEST

27. Freund’s Adjuvent Adhesive patches
SKIN SENSITISATION TEST

28. Initial injection
hypersensitivity
Patch -> Inflammatory
responce
Result Variation
Bases for estimating
the allergenicity ?
A. Degree of reaction
B. % of animals thats
shows reaction
SKIN SENSITISATION TEST

29. DECISION POINT APPROACH
Mutagenic/Cariogenic
property
Specific order When to stop?
FACTORS AFFECTING
TISSUES
SPECIES
GENDER
OTHER FACTORS

30. DECISION POINT APPROACH
TYPES
LIMITED TIME
IN-VIVO
LONG TERM/
LIFETIME TEST

31. subcutaneous
tissue
Evaluate the material
IMPLANTATION TEST

32. Evaluate the material
USE OF MATERIAL
MUSCLE
BONE
CT
IMPLANTATION TEST

33. Evaluate the material
A. Connective tissue
B. Bone
C. Muscle
D. Use of Material
IMPLANTATION TEST

34. Evaluate the material
A. Connective tissue
B. Bone
C. Muscle
D. Use of Material
IMPLANTATION TEST

35. Evaluate the material
A. Connective tissue
B. Bone
C. Muscle
D. Use of Material
IMPLANTATION TEST

36. Evaluate the material
A. Use of Material
Bone
Muscle
Connective tissue
MATERIALS THAT CONTACT
SOFT TISSUE DIRECTLY
A.ENDODONTIC
B.IMPLANTATION
C.PERIODONTAL TREATMENT
IMPLANTATION TEST

37. TYPESSHORT TERM
IMPLANTATION
LONG TERM
IMPLANTATION
IMPLANTATION TEST
Mice
Pigs
Dogs
Sheeps
Goats
Rats
Guinea Pigs
Rabbits

38. SHORT TERM IMPLANTATION
COMPOUND
test
material
control
placed at
separate site
remain for
1 - 11 weeks
polyethylene

39. SHORT TERM IMPLANTATION
allow inflammatory
reaction to subside
Reopen
implant
site
Placement
of test
material
Area is
excised
appropriate
time
Microscopic
examination /
Interpretation
Evaluation of
Tissue
Response
Histological
Histochemical
Immunohistochemical

40. LONG TERM IMPLANTATION
COMPOUND
test
material
control
placed at
separate site
remain for
1 - 2 YEARS

41. CONCLUSION

42. REFERRENCE
1. Craig’s - Restorative Dental materials - Twelfth Edition
2. Williams DF. Biocompatibility: an overview. In: Williams
DF, ed. Concise Encyclopaedia of Medical and Dental
Materials. Oxford: Pergamon, 1990, pp 51-59.
3. IS0 DIS 7405. Preclinical Evaluation of Biocompatibility of
Medical Devices Used in Dentistry, 1994.
4. Schmalz G. Characterisation of a simple dentin barrier
test.J Dent Res 1992; 72: 599.
5. Bergenholtz G, Ahlstedt S and Lindhe J. Experimental
pulpitis in immunised monkeys. Stand J Dent Res 1977;
85: 396-406.