1. Dental Standards & Testing Methods

2. Types of tests for biomaterials
Lab Tests
Clinical Tests

3. Clinical Tests – Advantages:
simulates the temperature, humidity, and fluid in the environment
simulates the mechanical forces exerted during mastication

4. Clinical Tests – Disadvantages:
patients highly variable – need large numbers: cost
specimens often not recoverable
studies take a very long time: cost
results may be skewed toward making the material look good

5. Clinical Tests – Sources of bias:
patient selection
skilled operators
study environment – University practices may not simulate typical dental practices
desire to please corporate sponsors

6. Laboratory Testing – advantages:
quicker and consequently cheaper
specimens can be recovered
no danger to patients or animals
testing conditions are repeatable – patient variability is not a factor

7. Laboratory Testing – disadvantages:
correct mechanical conditions are difficult to know
correct testing environment (temperature, saliva chemistry, pH, etc.) is difficult to know

8. Laboratory Testing – two types of tests:
use tests
try to simulate oral conditions (e.g., cyclic testing, 37oC, artificial saliva, etc.)
abuse tests
exaggerate clinical conditions – try to quickly produce results that predict long-term durability of materials

9. 1920 U.S. Army supports Wilmer Souder at the Nat’l Bureau of Standards
US Standards:
1920 U.S. Army supports Wilmer Souder at the Nat’l Bureau of Standards
Weinstein Fellowships at the NBS

10. US Standards:
ADA Fellowships support research at the NBS Over 20 Specifications are developed
ADA establishes Council on Dental Materials & Devices. More recently this council was merged with others to become the ADA’s Council on Scientific Affairs

13. American National Standards Institute Has assigned the
ADA to administer
American National
Standards Institute
These specification consist of packaging and labeling requirements and laboratory tests that the product must pass. Clinical efficacy is NOT evaluated.

15. ADA Seal of Acceptance:
Covers drugs, therapeutic agents, and materials:
1300 products currently carry the seal
30% sold to consumers
70% sold only to dentists
The ADA Seal Program for professional
products has been phased out. It ended completely on 12/31/07.
The Seal Program on consumer products
will continue.

16. after 2007
no longer covers
professional
products

17. ADA Professional Product Review
a quarterly insert that is included with the Journal of the Americans Dental Association
quantitative laboratory data on materials are reported
qualitative practitioner data is reported
replaces acceptance program (seal program), which was increasingly being ignored by both practitioners and manufacturers.

20. U.S. regulation of dental materials:
Some dental materials are regulated as “medical devices” by the Food & Drug Administration (FDA).
Medical Device Amendments of 1976

21. U.S. regulation of dental materials:
To administer the Medical Device
Amendments the FDA:
Set up 19 panels
One panel was the Panel on Review & Classification of Dental Devices

22. U.S. regulation of dental materials:
Three classes of devices:
Class I General controls
Class II Performance Standards
Class III Premarket Approval
Unclassified devices are treated as
Class II devices

23. U.S. regulation of dental materials:
General controls (Class I):
Ensure compliance with Good Manufacturing practices
Premarket notification (510K)
Class I: burs, preformed crowns, porcelain teeth

24. U.S. regulation of dental materials:
Performance Standards (Class II):
Ensure compliance with Good Manufacturing practices
Premarket notification (510K), but includes requirement to demonstrate “substantial equivalence” with existing products
Postmarket surveillance, patient registries
Class II: resin composites, impression materials, calcium hydroxide liners

25. U.S. regulation of dental materials:
Performance Standards (Class II):
“Substantial equivalence” can be demonstrated by compliance with recognized standards
The FDA has recognized 27 SCDP standards and 30 ISO standards

26. U.S. regulation of dental materials:
Premarket Approval (Class III):
Preamendment devices (on the market before 1976) – no premarket approval is required
PMA devices – materials that have a new use or greatly different composition will usually be classified as Class III requiring premarket approval

27. U.S. regulation of dental materials:
Premarket approval involves:
Laboratory tests
Preclinical studies (animal studies)
Clinical evidence of safety and effectiveness (expensive, time consuming)

28. International standards:
Federation Dentaire Internationale (FDI) – federation made up of national dental associations
Administers dental international standards for the ISO (International Organization for Standardization)
Technical committee in Dentistry – ISO / TC 106

29. International standards:
ISO / TC 106
Currently has 145 approved standards (2005, up from 105 in 1999)
Lab tests only (like ADA SCDP standards)

30. International standards:
CEN (Comité Européen de Normalization); Task Group 55 charged to develop European standards for dental materials, instruments, & equipment
CEN mark – products must have to sell in Europe
CEN usually adopts ISO dental standards
NOTE: Unlike U.S. standards, these standards are NOT voluntary. U.S. dentists benefit because manufacturers who want to sell in Europe (just about all manufacturers) must get the CEN mark.

31. The End