American Dental Association on Toothpastes

Toothpastes

Key Points

• All toothpastes with the ADA Seal of Acceptance must contain fluoride.
• In addition to fluoride, toothpastes may contain active ingredients to help in ways such as lessening tooth sensitivity, whitening teeth, reducing gingivitis or tartar build-up, or preventing enamel erosion or bad breath.
• Flavoring agents that cause or contribute to tooth decay (e.g., sugar) may not be contained in any ADA-Accepted toothpaste.
• 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.

Ingredients

Toothpaste typically consists of active and inactive ingredients.

Toothpastes may contain a number of active ingredients to help improve oral health.¹  For example, fluoride actively helps prevent tooth decay by strengthening tooth enamel.  Active ingredients may include²:

• • Anti-cariogenic agents: Fluoride in the form of sodium monofluorophosphate, sodium fluoride and stannous fluoride (these are the only agents accepted by the FDA as ingredients that help prevent caries). Fluoride strengthens teeth to help prevent tooth decay and remineralizes tooth enamel in the early stages of tooth decay.¹ All ADA-Accepted toothpastes must contain fluoride.
  • Anti-hypersensitivity agents: Potassium salts, stannous fluoride, amorphous calcium phosphate, casein phosphopeptide, and calcium sodium phosphosilicate are some ingredients that can help reduce tooth sensitivity.
  • Antimicrobial agents: Stannous fluoride and triclosan help reduce gingivitis. Pyrophosphates, triclosan and zinc citrate help reduce the build-up of tartar.

Other ingredients that toothpastes typically contain include:

• • Abrasive agents: Modified silica abrasives or enzymes help clean the teeth and may help whiten teeth by physically removing surface stains. Examples include calcium carbonate, dehydrated silica gels, hydrated aluminum oxides, magnesium carbonate, phosphate salts and silicates.
  • Detergents to create foaming action that may help increase the solubility of plaque and accretions during brushing. They include sodium lauryl sulfate, sodium N-Lauryl sarcosinate.
  • Flavoring agents, and non-caloric sweeteners like saccharin to improve taste. Sugar or any other cariogenic ingredient is not permitted in any ADA-Accepted toothpaste.
  • Humectants, such as glycerol, propylene glycol and sorbitol, to help prevent water loss in the toothpaste.
  • Thickening agents or binders to stabilize the toothpaste formula. They include mineral colloids, natural gums, seaweed colloids or synthetic cellulose.
  • Peroxide: Hydrogen and carbamide peroxides to help reduce intrinsic stains.

Allergens and Irritants

Toothpastes can contain ingredients that, in rare cases, may cause irritation or allergic reactions.  Essential oils, including spearmint, peppermint and cinnamon, are the most common source of perioral contact dermatitis, stomatitis, or cheilitis.^3,4 These may not be explicitly mentioned on the packaging instead being listed as unspecified “flavors.”  In addition, essential oils as well as fragrance mix,⁵ and menthol⁴ may induce allergic reactions or irritation to oral membranes.  Other common structural or active ingredients of toothpastes that have been reported as allergens or contact irritants include citric acid (often listed as zinc or potassium citrate), triclosan, sodium lauryl sulfate, propylene glycol, PEG-8, PEG-12, PEG-1450, cocamidopropyl betaine, parabens, and pyrophosphates.^4-9

The symptoms of contact dermatitis from toothpaste allergens include erythema, edema, desquamation and ulceration of the oral mucosa, gingiva, and/or tongue,^{5, 7, 9} which often may be difficult to differentiate from other intraoral causes, including dysfunctional or improperly placed prostheses or restorations.⁹

Toothpaste and Children

Brushing with fluoride toothpaste has been shown to reduce caries incidence in children.¹⁰ The National Academies of Sciences, Engineering and Medicine (formerly the U.S Institute of Medicine, IOM) estimates the amount of fluoride that reduces caries to the greatest extent without causing adverse effects to be 0.05 mg/kg/day (range 0.02 to 0.10 mg/kg/day) for all children older than 6 months.¹¹

Fluorosis may result from excess fluoride ingestion during the period in which permanent teeth are developing.¹² Primarily a cosmetic concern, fluorosis can range from mild—in which white flecks or striations appear on the tooth—to severe—which may result in brown spots and/or pitting of the enamel.¹³

Two studies in Brazil found that toothpaste accounts for most of the fluoride ingested by children.^{14, 15} Studies demonstrate that the amount of toothpaste swallowed is directly associated with the age of the child, with younger children swallowing more than older children when the same amount of toothpaste was used.¹⁶

The ADA recommends that children use a smear of toothpaste (the size of a grain of rice) from the time the first tooth erupts until age 3 years. After that point, from 3 years to 6 years, children should use a pea-sized amount of paste. According to the ADA, these amounts help limit the exposure of children to fluoride from ingested dentifrice to levels below those suggested by National Academies of Sciences, Engineering and Medicine (0.05 mg/kg/day).¹¹ For example, if a child weighing 15 kg brushed twice per day, using a rice-sized smear of toothpaste (approximately 0.1 gram of toothpaste or 0.1 milligram of fluoride), swallowed the entire smear he or she would ingest 0.2 mg of fluoride, resulting in a dose of 0.013 mg/kg. Under those same conditions, the Association estimates, a child using a pea-sized amount (approximately 0.25 g toothpaste or 0.25 mg fluoride) would ingest 0.5 mg fluoride, resulting in a dose of 0.033 mg/kg.¹⁷

In addition to the appropriate amount of toothpaste to be used, the ADA recommends that caregivers supervise children during brushing to ensure that the children spit rather than swallow the paste.¹⁷ Educating caregivers on these recommendations is essential as Zohoori et al. found that, on average, caregivers used up to twice the suggested amount of toothpaste.¹⁸

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).¹⁹  This scale assigns dentifrices an abrasivity value, relative to a standard reference abrasive that is arbitrarily given an RDA value of 100.^{19, 20}  All dentifrices at or below 2.5 times the reference value, or 250 RDA, are considered safe and effective.²¹ 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.²²

Relative dentin abrasivity can be used by industry, researchers, or standards organizations to develop new products or to conduct quality control.²⁰It should not be used to rank the safety of dentifrices with RDA values below 250.  These values do not correspond to potential clinical changes to enamel.^{19, 20}

The RDA testing method and the upper limit of 250 has been adopted by the American National Standards Institute/American Dental Association (ANSI/ADA) and is included in the manufacturing standards outlined in ANSI/ADA Standard No. 130:2013 on toothpastes.²³

All dentifrices with the ADA Seal of Acceptance must have an RDA of 250 or less.

Earning the ADA Seal of Acceptance

To earn the Seal, 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 from the ANSI/ADA specification on toothpaste,²³ as well as additional laboratory studies including:

• • the amount of available fluoride;
  • fluoride release in one minute;
  • fluoride absorption in normal and weakened tooth enamel.

In some situations, the ADA also conducts laboratory tests on toothpastes to determine whether they meet specific criteria for safety and efficacy. For example, the ADA may test to determine a product’s fluoride content and how it is released.

While the U.S. Food and Drug Administration monograph²⁴ stipulates 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 Seal of Acceptance program requires that the product be in compliance with the FDA monograph, in addition to meeting ADA Seal requirements.

Get a Complete List of ADA Accepted Toothpastes.

References:

1. Croll TP, DiMarino J A Review of Contemporary Dentifrices.  2014.  Accessed Oct. 11 2017.
2. Food and Drug Administration. Part 355. Anticaries Drug Products for Over-the-Counter Human Use; 2015.
3. Zirwas MJ, Otto S. Toothpaste allergy diagnosis and management. J Clin Aesthet Dermatol 2010;3(5):42-7.
4. Moreau J, Kaplan B. Toothpaste-associated labial allergic contact dermatitis. Allergy 2013;68:598-98.
5. Stoopler ET. AAOM Clinical Practice Statement. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology 2016;122(1):50-52.
6. Basch CH, Kernan WD. Ingredients in Children’s Fluoridated Toothpaste: A Literature Review. Global Journal of Health Science 2016;9(3):1.
7. Davies R, Scully C, Preston AJ. Dentifrices-an update. Med Oral Patol Oral Cir Bucal 2010;15(6):e976-82.
8. Jin LZ, Rangan A, Mehlsen J, et al. Association Between Use of Cannabis in Adolescence and Weight Change into Midlife. PLoS ONE 2017;12(1):e0168897.
9. De Rossi SS, Greenberg MS. Intraoral contact allergy: a literature review and case reports. The Journal of the American Dental Association 1998;129(10):1435-41.
10. Centers for Disease Control and Prevention. Recommendations for Using Fluoride to Prevent and Control Dental Caries in the United States. MMWR Morbidity and Mortality Weekly Report 2001;50(RR-14).
11. S. Institute of Medicine Dietary Reference Intakes for Calcium, Phosporus, Magnesium, Vitamin D and Fluoride. Accessed September 1 2017.
12. Clark MB, Slayton RL. Fluoride use in caries prevention in the primary care setting. Pediatrics 2014;134(3):626-33.
13. Levy SM. An update on fluorides and fluorosis. J Can Dent Assoc 2003;69(5):286-91.
14. de Almeida BS, da Silva Cardoso VE, Buzalaf MA. Fluoride ingestion from toothpaste and diet in 1- to 3-year-old Brazilian children. Community Dent Oral Epidemiol 2007;35(1):53-63.
15. Pessan JP, Silva SM, Buzalaf MA. Evaluation of the total fluoride intake of 4-7-year-old children from diet and dentifrice. J Appl Oral Sci 2003;11(2):150-6.
16. Ekambaram M, Itthagarun A, King NM. Ingestion of fluoride from dentifrices by young children and fluorosis of the teeth–a literature review. J Clin Pediatr Dent 2011;36(2):111-21.
17. American Dental Association Council on Scientific Affairs. Fluoride Toothpaste Use for Young Children. J Am Dent Assoc 2014;145(2):190-91.
18. Zohoori FV, Duckworth RM, Omid N, W.T. OH, A. M. Fluoridated Toothpaste: Usage and Ingestion of Fluoride by 4- to 6-year-old Children in England. Eur J Oral Sci 2012;120:415-21.
19. Abrasivity of current dentifrices. Council on Dental Therapeutics. J Am Dent Assoc 1970;81(5):1177-8.
20. Gonzalez-Cabezas C, Hara AT, Hefferren J, Lippert F. Abrasivity testing of dentifrices – challenges and current state of the art. Monogr Oral Sci 2013;23:100-7.
21. St John S, White DJ. History of the Development of Abrasivity Limits for Dentifrices. J Clin Dent 2015;26(2):50-4.
22. 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.
23. American National Standards Institute/American Dental Association. ANSI/ADA Standard No. 130:2013 Dentifrices – Requirements, Test Methods and Marking.  2013.
24. S. Food & Drug Administration. Code of Federal Regulations (CFR) Title 21; 2006. p. 300-04.

ADA Resources

Prepared by: Center for Scientific Information, ADA Science Institute
Topic last updated: November 29, 2017

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*Online as of March 7, 2018, at the website of the American Dental Association, https://www.ada.org/en/member-center/oral-health-topics/toothpastes