Oral Health Topics
- All toothpastes with the ADA Seal of Acceptance contain fluoride.
- In addition to fluoride, toothpastes may contain active ingredients to help improve tooth sensitivity, whiten teeth, or reduce gingivitis or tartar build-up.
- Toothpastes with the ADA Seal of Acceptance do not contain any flavoring agent that causes or contributes to tooth decay (e.g., sugar).
- A product earns the ADA Seal of Acceptance by providing scientific evidence that demonstrates the safety and efficacy, which the ADA Council on Scientific Affairs carefully evaluates according to objective requirements.
Prepared by: Center for Scientific Information, ADA Science Institute
Toothpaste, also called dentifrice, can be marketed as a paste, gel or powder.
Toothpaste ingredients typically consist of:
- Mild abrasives to remove debris and residual surface stains. Examples of abrasives include calcium carbonate, dehydrated silica gels, hydrated aluminum oxides, magnesium carbonate, phosphate salts and silicates.
- Fluoride to strengthen tooth enamel and remineralize enamel in the early stages of tooth decay.1 All ADA-Accepted toothpastes contain fluoride.
- Humectants to prevent water loss in the toothpaste. Examples include glycerol, propylene, glycol and sorbitol.
- Flavoring agents, such as saccharin and other sweeteners improve taste. No ADA-Accepted toothpaste contains sugar or any other ingredient that would promote tooth decay.
- Thickening agents or binders to stabilize the toothpaste formula. They include mineral colloids, natural gums, seaweed colloids or synthetic cellulose.
- Detergents to create foaming action. They include sodium lauryl sulfate, sodium N-Lauryl sarcosinate.
Toothpastes may contain a number of active ingredients to help improve oral health. Fluoride actively helps prevent tooth decay by strengthening tooth enamel.
Other active ingredients may include:
- Potassium nitrate to help reduce tooth sensitivity.
- Stannous fluoride and triclosan help reduce gingivitis.
- Pyrophosphates, triclosan and zinc citrate help reduce the build-up of tartar.
- Modified silica abrasives or enzymes can help whiten teeth by physically removing surface stains. Hydrogen peroxide also may be added to help reduce intrinsic stains.
Relative Dentin Abrasivity (RDA)
Although tooth enamel is the hardest substance in the body, the dentin that lies beneath it can become exposed—through, for example, wear of the enamel or gingival recession. Because of concern about abrasion of these tissues, scientists have spent decades researching and monitoring the effect of dentifrice abrasives on these tooth structures.
To help quantify the abrasivity of dentifrices, the ADA along with various academic, industry and government agencies established a standardized scale called Relative Dentin Abrasivity (RDA).1 This scale assigns dentifrices a value from 0 to 250, relative to a standard reference abrasive that is arbitrarily given an RDA value of 100.1, 2 All dentifrices at or below 250 RDA are considered safe and effective.3 In fact, clinical evidence supports that lifetime use of proper brushing technique with a toothbrush and toothpaste at an RDA of 250 or less produces limited wear to dentin and virtually no wear to enamel.4
Relative dentin abrasivity can be used by industry, researchers, or standards organizations to develop new products or to conduct quality control.2 It should not be used to rank the safety of dentifrices with RDA values below 250. These values do not correspond to potential clinical effects, like abrasion.1, 2
The RDA testing method and the upper limit of 250 has been adopted by the International Standards Organization (ISO) and is included in the manufacturing standards, ISO Toothpaste Specification 11609.5
All dentifrices with the ADA Seal of Acceptance have an RDA of 250 or less.
Earning the ADA Seal of Acceptance
Fluoride toothpastes must meet the ADA’s Council on Scientific Affairs requirements for safety and efficacy in reducing tooth decay. The ADA Council on Scientific Affairs carefully evaluates the evidence according to the requirements for fluoride-containing dentifrice.
The manufacturer must provide data from:
- Clinical studies in humans
- Laboratory studies to determine the amount of available fluoride, the amount of fluoride released in one minute, and the amount of fluoride absorption in normal and weakened tooth enamel. These tests also are conducted in the ADA’s laboratory.
While the U.S. Food and Drug Administration
insists that manufacturers of fluoride-containing toothpaste meet certain requirements for the product’s active ingredients, product indications, claims and other qualifications, the FDA does not test toothpastes to verify compliance. The ADA conducts extensive laboratory tests on toothpastes to determine whether they meet specific criteria for safety and efficacy. For example, the ADA determines the product’s fluoride content, how it is released and its effectiveness on tooth enamel.
[ADA] Council on Dental Therapeutics. Abrasivity of current dentifrices. J Am Dent Assoc 1970;81(11):1177-8.
- Gonzalez-Cabezas C, Hara AT, Hefferen J, Lippert F. Abrasivity testing of dentifrices—Challenges and current state of the art. Monogr Oral Sci 2013;23:100-7.
- St. John S, White DJ. History of the development of abrasivity limits for dentifrices. J Clin Dent 2015;26(2):50-4.
- Hunter ML, Addy M, Pickles MJ, Joiner A. The role of toothpastes and toothbrushes in the aetiology of tooth wear. Int Dent J 2002;52:399-405.
- International Standards Organization. Dentistry—dentifrices—requirements, test methods and marking. ISO 11609; 2010(E).
Topic last updated: April 13, 2017
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