Performance standards for dental materials

History:
  600-300 BC restorative dentistry appeared Christian era:  Gold shells  Fixed bridges  Partial and full dentures  Mid. Ages-1800s:  Extractions and artificial replacement   1700 : ivory used to construct complete dentures. Porcelain teeth first fabricated and used. 1844: vulcanite (rubber material) used for denture base construction and remained so until WWII 659-1800: silver pastes first introduced by Chinese then French 1846: amalgam banned due to health hazard of mercury 1855: gold foil used in restorative dentistry Late 1800 zinc phosphate 1874: fluorides 1895: G.V. Black introduced an acceptable amalgam formula 1907: casting method for gold inlays developed 1932: synthetic resins developed then replaced vulcanite in making dentures and as esthetic restorative material 1955: acid etching technique introduced 1945: water fluoridation 1960s: composite resins as esthetic material 1970s: glass ionomer cements 1980s: dentine bonding agents, resin modified-GIC 1990s: compomers

       

     

Performance standards for dental materials

y Evaluation of dental materials

 
.     

The study of dental materials takes into consideration certain standards set forth to evaluate a material or a technique before it is used in the patients mouth. Main organizations are

American Dental Association (ADA) National institute of standards and technology[NIST] Food and Drug Administration (FDA) International Standards Organization (ISO) Federation Dentaire Internationale (FDI)

*FDI and ISO establish standards for DM on an international level*  ISO-TC, ISO TC 106 is for Dentistry AIMS:

 

Evaluation of composition, properties of various dental materials. Selection criteria for dental materials, to protect the patients from various biohazard materials.

Standards for dental materials;

 In 1919, US army requested the national bureau of standards(now known as National Institute of Standards and Technology) to set up specifications for evaluation and selection of dental amalgams for use in federal service.  In 1928, the dental research fellowship an national bureau of standards was assumed by the American Dental Association(ADA). American Dental Association (ADA)
 1930 ADA established guidelines for testing products and awarded the first ADA Seal of Acceptance in 1931.  ADA staff review dental materials, drugs, instruments, equipments  ADA Council on Scientific Affairs is responsible for formulating standards for physical, mechanical and chemical properties of dental materials to ensure their quality Qualifying for ADA seal of acceptance  Takes 3 months to be awarded  Lasts for 5 years then reevaluated. Manufacturer maybe required to submit new reports and study results

Performance standards for dental materials

 Provisional acceptance: Awarded to products that lack sufficient evidence to justify acceptance, but there is reasonable evidence of safety. Approval is reviewed yearly up to 3 years

 When applying for the ADA seal manufacturer should:

 Supply objective data from clinical, lab studies supporting product safety  Conduct clinical trials  Provide evidence of properly supervised and adequate manufacturing and lab facilities  Submit promotional & Patient education material for review

 Submit patient information, ingredient list for review U.S Food and Drug Administration regulations:




It is a regulatory authority to protect the public from hazardous or infective medical and
dental devices. Dental materials and over the counter products are subject to control and regulation by the FDA Center for Devices and Radiological Health Classifies items according to their hazards or problems into class I, II, III Class 1: considered as low risk Class 2: products in this class are required to meet performance standards. Class 3: most stringent category, requires that

   

 Devices be approved for safety and effectiveness before they are marketed  All implanted or life supporting devices are placed in the pre-market clearance category.

Federation dentaire international(FDI)

 FDI initiated and actively supported a program for the formulation of international specifications for dental materials.  It request to ISO that they consider FDI specifications for dental materials as ISO standards led to the ISO technical committee(TC), TC106- Dentistry

International Standards Organization (ISO)

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Performance standards for dental materials

 Composed of national standards organization from more than 80 countries  ISO Technical committee (ISO-TC): To standardize terminology and test methods and also develop standards for different dental materials  In 2002, the international organization for standardization had 224 TCs(technical committees) for testing safety and efficacy of dental products.

 A total of 134 ISO dental standards have been published related TC and it SC s(subcommittees) and working groups(WG s). Example:  TC 106/SC1: filling and restorative materials  TC 107/SC2: prosthodontic materials
How are ISO standards developed?  Input information come from:  Manufacturers  Users  Consumer groups  Dentists  Laboratories  Research organizations Other dental standards organizations

 Australian Dental Standards Laboratory  Scandinavian Institute of Dental Materials  European Economic Community (CEN)  Nordisk institute for odontologisk material proving (NIOM).