A company earns the ADA Seal for its product by providing evidence that meets the ADA criteria for safety and efficacy. The ADA Council on Scientific Affairs carefully evaluates the evidence according to the
Guidelines for Participation in the ADA’s Seal of Acceptance Program. In addition, the ADA Council has adopted a specific guideline for this product category called
Chemotherapeutic Products for Control of Gingivitis. The Guideline includes, but is not limited to, the following criteria:
- Two independent, well designed, 6-month clinical studies utilizing a placebo control showing significant reduction in gingivitis for the test product vs. the control
- Data showing that the plaque bacteria do not become resistant to the test product
- Data showing that the test product does not allow pathogenic or opportunistic plaque bacteria to flourish
- Data showing that oral soft tissues and teeth are not harmed
- Toxicology and mutagenicity studies to assess possible adverse effects at the cellular level
In lieu of the bulleted items listed above, there is another, equally valid way that some mouthrinses may demonstrate safety and efficacy by using
surrogate tests. These tests measure surrogates that have been shown to correlate with the control of plaque and gingivitis. Well-designed surrogate tests are much quicker and easier to do than clinical studies, and are just as valid at showing product effectiveness. A company may elect to perform surrogate tests rather than clinical studies if its mouthrinse contains the same active agent combination of essential oils as a clinically tested mouthrinse. The company is required to demonstrate that its product behaves the same as the clinically tested product on the following surrogate tests:
- Oral irritation/sensitization clinical study
- Determination of minimal inhibitory concentration, minimal bactericidal concentration and kill time of product on plaque bacteria
This product was Accepted based on submission of
surrogate tests.
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