211 East Chicago Avenue

Chicago, IL 60611

312-440-2523

Contact: Kenneth H. Burrell, Secretary.

Overview: The American Dental Association (ADA) is a professional association that provides a variety of services to assist the profession in delivering health care to the public. The ADA's objectives include encouraging the improvements of the public's health, promoting the art and science of dentistry, and representing the interests of the members of the dental profession and the public that it serves. The Council on Dental Therapeutics is one of two technology assessment programs sponsored by the ADA; the other being the Council on Dental Materials, Instruments, and Equipment. The Council supplies reliable information and confers a seal of acceptance, provisional acceptance, and unacceptance on recently developed dental products.

Purpose: To study, evaluate, and disseminate information on 1) the proper use of dental therapeutics, their adjuncts, and dental cosmetic agents offered to the public or profession; and 2) aspects of the dental practice environment related to the health of dentists, dental auxiliaries, and the public.

Primary intended users: General public, patients, dentists.

Technologies: Drug, medical or surgical procedure.

Examples of technologies evaluated by the Council are: topical fluoride preparations, analgesics, antianxiety agents, anticholinergic drugs, antihistamines for control of allergic reactions, artificial salivas, astringents for gingival retraction, chemical disinfecting/ sterilizing agents, corticosteroids, fluoride dentrifices, fluoride mouthrinses, formocresol preparations, hand antiseptics, hemostatic agents, hypochlorite substances, inhalation anesthetics, local anesthetics, muscle relaxants, nutritional supplements, oral antiseptics, periodontal dressings, pharmaceutical aids, phenolic compounds, respiratory stimulants, root canal calcium chelating agents, sedatives and hypnotics, sterilizing agents, topical protectants, vasoconstrictors, and zinc oxide preparations.

Intervention: Prevention, diagnosis, and treatment.

Stages: New, emerging, established or widespread practice.

Properties: Safety, efficacy, effectiveness.

The Council also considers if the products meet standards of acceptance with respect to composition, advertising, and labeling.

Selection process: Commercial products are evaluated at the request of a manufacturer or distributor, or at the Council's initiative. Any firm may submit appropriate products to the Council for the consideration of acceptance. Communications must be submitted in writing through the Secretary of the Council.

The Manufacturers normally submit the following types of information: product name, composition, physical and chemical properties of product; evidence of safety and effectiveness; government regulations related to the product; and promotional materials.

Methods: Information syntheses, expert opinion, group judgment, bench testing.

The steps required for the review of products in the Council's acceptance program depend on several factors. For example, if a product is essentially the same as an existing accepted product and does not require chemical analysis by the Council's laboratory or review by consultants, the process will require fewer steps.

After consideration of a product has been completed, the Council classifies the product as "accepted," "provisionally accepted," or "unaccepted.'' Products are generally accepted for three years. Acceptance is renewable and may be reconsidered at any time. If there is a change in the product's manufacturer or distributor, the acceptance automatically expires.

"Accepted" products include those for which there is adequate evidence of safety and effectiveness. They may use the Council's "Seal of Acceptance" and/or an authorized statement, unless otherwise provided. "Provisionally accepted" products include those for which there is reasonable evidence of safety and effectiveness, but which lack sufficient evidence of dental effectiveness to justify being accepted. These products meet other qualifications and standards established by the Council. "Unaccepted" products include those for which the Council has determined that there is no substantial evidence of effectiveness, or that a question of safety exists.

Dissemination: Accepted products are listed in Accepted Dental Therapeutics and may be described in suitable reports in the Journal of the American Dental Association See for example, Product listing: accepted therapeutic products. J Am Dent Assoc 1986 Dec; 113:1018-1023. When it is in the best interest of the public or the profession, the Council may submit reports on unaccepted products for publication in the Journal of the American Dental Association.

Budget: Not available. Funding source: 100 percent parent organization. Evaluators and consultants donate their time.

Use: The information is used by the ADA membership and the public.