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Dr mumtaz ul islam

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 Evaluation of the safety and effectiveness of dental materials  A uniform method for manipulation
  • Evaluation of the safety and effectiveness of dental materials

  • A uniform method for manipulation of dental materials

 Paracelsus (1493-1540) a Swiss physician and alchemist, formulated a revolutionary principle that have remained an

Paracelsus

(1493-1540)

a

Swiss

physician and

alchemist, formulated a revolutionary principle that

have remained an integral part of the current field of toxicology. He stated that "all substances are poisons, there is none which is not a poison The right dose

differentiates a poison from a remedy.Source: Gallo and Doull, 1991.

 Relative term  No material is absolutely safe each and every dental material have some
  • Relative term

  • No material is absolutely safe each and every dental material have some disadvantages

  • Safety means benefits are more than other effects

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 Dentists and patients are more protected as well as more exposed to infections  Safety
  • Dentists and patients are more protected as well as more exposed to infections

  • Safety will be assured by strictly adherence with the safety standards

  • Safety ,durability and efficacy of dental materials can be enjoyed by following standards and vice versa

 Advancement in the knowledge of dental materials and their manipulation began in 1919. during that
  • Advancement in the knowledge of dental materials and their manipulation began in 1919. during that year the U.S. Army requested the National Bureau of Standards (now known as the National Institute of Standards and Technology [NIST]) to set up specifications)

  • For dental amalgam which will be used for federal

services

 This research was done under the leadership of Wilmer Souder, and an excellent report on
  • This research was done under the leadership of Wilmer Souder, and an excellent report on this study was published in 1920

  • The contents of the Souder report was received enthusiastically by the dental profession

  • Similar testing data were then requested for other dental materials

 There were no funds with the government  A fellowship was created and supported by
  • There were no funds with the government

  • A fellowship was created and supported by the Weinstein Research Laboratories

  • Sponsors have to pay the expenditure

  • Dr sauder was the supervisor of the committee

 Several research associates investigated the properties of dental wrought gold materials, casting gold alloys, and
  • Several research associates investigated the properties of dental wrought gold materials, casting gold alloys, and accessory casting materials

  • This phase of the work resulted in the publication of an extensive and valuable research report In 1928

  • Researchers such as Wilmer Soudr, George C Paflenbargel and William T Sweeney will undoubtedly be remembered historically as the pioneers

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 Until 1965, one of the primary objectives of the facility at NlST was to formulate
  • Until 1965, one of the primary objectives of the facility at NlST was to formulate standards or specifications for dental materials

  • In 1928, the Dental Research fellowship at the National Bureau of Standards was assumed by the American Dental Association (ADA)

 The research carried out by the ADA research associates in conjunction with the staff members
  • The research carried out by the ADA research associates in conjunction with the staff members of NIST has been of inestimable value to the dental profession, and it has earned for this group an international reputation

  • Now researches were made for ADA

  • Until 1965, the primary objectives of the NlST was to formulate standards or specifications for dental materials

 ADA Council on Dental Materials and Devices (now known as the Council on Scientific Affairs)
  • ADA Council on Dental Materials and Devices (now known as the Council on Scientific Affairs) was established in 1966

  • On acceptance of a material by ADA manufacturers were allowed to use ADA mark on their products

  • The ADA, accredited by the American National Standards Institute (ANSI)

  • The ADA Standards Committee for Dental products

(SCDP) develops specifications for all dental materials

 The Council on Scientific Affairs (CSA) is also responsible for the evaluation of drugs, tooth
  • The Council on Scientific Affairs (CSA) is also

responsible for the evaluation of drugs, tooth cleaning

and tooth whitening agents therapeutic agents used in dentistry, dental equipment, and dental x-ray film

  • When a specification has been approved by the ADA SCDP and the ADA CSA, it is submitted to the American National Standards Institute

  • On acceptance by that body it becomes an American National Standard

 Specifications are periodically revised to reflect changes in product formulations new knowledge about the behavior
  • Specifications are periodically revised to reflect changes in product formulations new knowledge about the behavior of materials in the oral cavity for example the ANSI/ADA Specification No. 1 for dental amalgam which was revised in January 2003

 U.S. Food and Drug Administration (FDA) the regulatory authority to protect the public from hazardous
  • U.S. Food and Drug Administration (FDA) the regulatory authority to protect the public from hazardous or ineffective medical and dental devices on May 28, 1976

 Class 1  Generals measures application during manufacturing  low risk materials  Class 2
  • Class 1

  • Generals measures application during manufacturing

  • low risk materials

  • Class 2

  • General measures if not supposed to be adequate

  • Class 3

  • Thorough control of safety and effectiveness prior to marketing is mandatory

 Federation Dentaire Internationale (FDI)  International Organization for Standardization (ISO)  The IS0 is an
  • Federation Dentaire Internationale (FDI)

  • International Organization for Standardization (ISO)

  • The IS0 is an international, nongovernmental organization whose objective is the development of international standards. This body is composed of national standards organizations from more than 80 countries

 Manufacturers, dental vendors, users, consumer groups, testing laboratories, governments, the dental profession, and research organizations
  • Manufacturers, dental vendors, users, consumer groups, testing laboratories, governments, the dental profession, and research organizations provide input information and requirements for the development of standards. International standardization is market driven and is based on voluntary involvement of all interests in the marketplace

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 The work at he National lnstitute of Standards and technology in Gaithersburg Maryland has stimulated

The work at he National lnstitute of Standards and

technology in Gaithersburg Maryland has stimulated

comparable programs in other countries

The Australian Dental Standards Laboratory was established in 1936 (until 1973 this facility was known as the Commonwealth Bureau of Dental Standards)

 Other countries that have comparable organizations for developing standards and certifying products are Canada Japan
  • Other countries that have comparable organizations for developing standards and certifying products are Canada Japan France Czech Republic Germany Hungary Israel India Poland and South Africa

  • NlOM (Nordisk Institutt for Odontologisk Material provning)

  • The governments of Denmark Finland Iceland Norway and Sweden were the founders of NIOM

  • It becomes operational in 1973

 Europe, the Comite Europeen de Normalisation (CEN)  The CE marking on product labels denotes
  • Europe, the Comite Europeen de Normalisation (CEN)

  • The CE marking on product labels denotes the European mark of conformity

  • All medical devices marketed in the European Union countries must have the CE mark of conformity

 Some countries may enforce their own standards  Other countries or the international community have
  • Some countries may enforce their own standards

  • Other countries or the international community have not developed mutually acceptable requirements For example Sweden restricts the use of nickel in cast dental alloys because of biocompatibility concerns whereas no such restriction applies to those alloys in the United States, Iceland, Liechtenstein and Norway

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