Toothpastes

Key Points

  • All toothpastes with the ADA Seal of Acceptance must contain fluoride.
  • In addition to fluoride, toothpastes may contain other ingredients that improve oral health such as lessening tooth sensitivity, reducing gingivitis or tartar build-up, or preventing enamel erosion; or that cosmetically affect the mouth such as whitening teeth or improving 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 submitting data and publications to the ADA Council on Scientific Affairs to use in making a determination of whether the product meets the prespecified requirements for safety and efficacy.
FDA Monograph

The U.S. Food and Drug Administration (FDA) monograph on over-the counter anticaries agents1provides a definition of toothpaste or “dentifrice,” as “An abrasive-containing dosage form (gel, paste, or powder) for delivering an anticaries drug to the teeth.” An anticaries drug is defined as “A drug that aids in the prevention and prophylactic treatment of dental cavities (decay, caries)” (see next section, “Ingredients”).

Ingredients

Toothpastes contain both active and inactive ingredients.

Toothpastes may contain a number of active ingredients to help improve oral health.2 For example, fluoride actively helps prevent tooth decay by strengthening tooth enamel. Active ingredients may include:

  • Anticaries agents: Fluoride-containing compounds in the form of sodium monofluorophosphate, sodium fluoride and stannous fluoride are used as anticaries agents in toothpastes. These are the only compounds to prevent caries compounds mentioned in the FDA monograph.1 Fluoride strengthens teeth to help prevent tooth decay and remineralizes tooth enamel in the early stages of tooth decay.1 It is a requirement that for a toothpaste to be ADA-Accepted it must contain fluoride.
  • Desensitizing agents: Dentin hypersensitivity occurs in about 11.5% of patients which can be evaluated as sensitivity to touch, temperature, and air current.3A 2020 network meta-analysis by Martins et al.4 compared the various ingredients included in toothpaste formulations to reduce hypersensitivity and found differences among the compounds evaluated in terms of efficacy depending on type of stimulus tested. The following table uses the data from that analysis and present the interventions found to have large beneficial effects as mean difference in pain compared to fluoride. Only those formulations with moderate or higher certainty of the evidence are presented here; the table entries marked with an asterisk (*) had high levels of certainty.

 

Table. Efficacy of Dentin Hypersensitivity Interventions for Various Stimuli

Tactile Stimulus Cold Stimulus Air Stimulus

Potassium + stannous fluoride (3.49 [1.93,5.05])

Calcium sodium phosphosilicate (4.43 [0.38,8.49])

Potassium + hydroxyapatite (4.21 [0.57,7.85])

Potassium + hydroxyapatite (2.83 [0.34,5.31])

 

Potassium + stannous fluoride (3.94 [1.50,6.37])

CSP (2.45 [0.86,4.04])

 

Arginine (3.83 [2.50,5.16])

Stannous fluoride (2.31 [1.21,3.42])

 

Calcium sodium phosphosilicate* (3.42 [1.71, 5.14])

Strontium (1.41 [0.55,2.76])

 

Stannous fluoride* (3.28 [1.78, 5.14)

Potassium (1.41 [0.55,2.27])

 

 

  • Antimicrobial agents: Triclosan is FDA approved as an ingredient to prevent bacterial contamination in consumer products.5 While it has FDA approval when in combination with fluoride, as a drug that aids in the prevention of cavities, plaque, and gingivitis, as of 2019, toothpaste containing triclosan is no longer commercially available in the US.

 

Other ingredients that toothpastes may include:

  • Abrasive agents: Modified silica abrasives or enzymes help clean the teeth and may whiten teeth by physically removing surface stains. Examples include calcium carbonate, dehydrated silica gels, hydrated aluminum oxides, magnesium carbonate, phosphate salts and silicates.
  • Detergents such as sodium lauryl sulfate, sodium N-lauryl sarcosinate are used for foaming action that may increase the solubility of plaque and accretions on teeth during brushing.
  • Flavoring agents, and non-caloric sweeteners are common in toothpaste, though sugar or any other cariogenic ingredient is not permitted in any ADA-Accepted toothpaste. A 2018 systematic review and meta-analysis found that dentifrice flavoring did not increase toothpaste ingestion by children.6
  • Humectants, such as glycerol, propylene glycol and sorbitol, minimize water loss in the toothpaste.
  • Thickening agents or binders such as mineral or seaweed colloids, natural gums, or synthetic cellulose may be included in toothpaste formulations to stabilize the product.
  • Peroxide: Hydrogen and carbamide peroxides to lighten intrinsic stains.

 

The Microbead-Free Waters Act of 2015 prohibits cosmetics and over-the-counter drugs from containing microbeads as of July 2019.7



Allergens and Irritants

Toothpastes can contain ingredients that may rarely cause irritation or allergic reactions. Essential oils, including spearmint, peppermint and cinnamon, are the most common source of perioral contact dermatitis, stomatitis, or cheilitis.8, 9 These may not be explicitly mentioned on the packaging, but may instead be among unspecified “flavors.” Essential oils, fragrance mix,10 and menthol9 may induce allergic reactions or irritation to oral membranes. Other common ingredients of toothpastes that have been reported as allergens or contact irritants include citric acid (often listed as zinc or potassium citrate), sodium lauryl sulfate, propylene glycol, PEG-8, PEG-12, PEG-1450, cocamidopropyl betaine, parabens, and pyrophosphates.9-13

Symptoms of contact dermatitis from toothpaste allergens can be difficult to differentiate from other sources of irritation and can include erythema, edema, desquamation and ulceration of the oral mucosa, gingiva, and/or tongue.10, 12, 13

Toothpaste and Children

Brushing with fluoride toothpaste has been shown to reduce caries incidence in children.14 The National Academies of Sciences, Engineering and Medicine Health and Medicine Division (HMD; formerly the 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.15

Fluorosis may result from excess fluoride ingestion during the period in which permanent teeth are developing.16 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.17

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.18 And although a study published in 2019 suggested that children in the US commonly use more toothpaste than is recommended,19 a 2018 systematic review and meta-analysis found that the addition of flavoring to toothpaste did not increase ingestion of toothpaste by children.6

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 the HMD (0.05 mg/kg/day).15 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.20

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.20 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.21

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, enamel wear or gingival recession.

The Relative Dentin Abrasivity (RDA) is a standardized scale developed by the ADA, governmental agencies and other stakeholders to quantify the abrasivity of dentifrices.22 It assigns dentifrices an abrasivity value, relative to a standard reference abrasive that is arbitrarily given an RDA value of 100.22, 23 All dentifrices at or below 2.5 times the reference value, or 250 RDA, are considered safe and effective.24 Clinical evidence suggests lifelong 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.25

Relative dentin abrasivity is used by industry, researchers, or standards organizations to develop new products or to conduct quality control.23 It should not be used to rank the safety of dentifrices. However, RDA values below 250 cannot be used quantitatively to rank safety of toothpastes as these values do not correspond to potential clinical changes to enamel.22, 23

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. 130:2020 on toothpastes.26

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,26 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.

Although the U.S. Food and Drug Administration monograph27 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. Toothpastes with the ADA Seal of Acceptance have provided the ADA CSA with data that can be evaluated to determine whether the product is in compliance with the FDA monograph and ADA Seal requirements.


References
  1. U.S. Food and Drug Administration. Part 355. Anticaries Drug Products for Over-the-Counter Human Use. 2017. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=355.50. Accessed July 6, 2021.
  2. Croll TP, DiMarino J. A Review of Contemporary Dentifrices. 2014. https://www.dentalacademyofce.com/courses/2697/PDF/1409cei_Croll_premier_web.pdf. Accessed July 6, 2021.
  3. Favaro Zeola L, Soares PV, Cunha-Cruz J. Prevalence of dentin hypersensitivity: Systematic review and meta-analysis. J Dent 2019;81:1-6.
  4. Martins CC, Firmino RT, Riva JJ, et al. Desensitizing Toothpastes for Dentin Hypersensitivity: A Network Meta-analysis. J Dent Res 2020;99(5):514-22.
  5. U.S. Food and Drug Administration. 5 Things to Know About Triclosan. https://www.fda.gov/consumers/consumer-updates/5-things-know-about-triclosan. Accessed July 8, 2021.
  6. Vieira TI, Mangabeira A, Alexandria AK, et al. Does flavoured dentifrice increase fluoride intake compared with regular toothpaste in children? A systematic review and meta-analysis. Int J Paediatr Dent 2018;28(3):279-90.
  7. U.S. Food and Drug Administration. The Microbead-Free Waters Act: FAQs. U.S. Food & Drug Administration 2015. https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm531849.htm. Accessed July 6, 2021.
  8. Zirwas MJ, Otto S. Toothpaste allergy diagnosis and management. J Clin Aesthet Dermatol 2010;3(5):42-7.
  9. Moreau J, Kaplan B. Toothpaste-associated labial allergic contact dermatitis. Allergy 2013;68:598.
  10. Stoopler ET. AAOM Clinical Practice Statement. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology 2016;122(1):50-52.
  11. Basch CH, Kernan WD. Ingredients in Children’s Fluoridated Toothpaste: A Literature Review. Global Journal of Health Science 2016;9(3):1.
  12. Davies R, Scully C, Preston AJ. Dentifrices-an update. Med Oral Patol Oral Cir Bucal 2010;15(6):e976-82.
  13. 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.
  14. 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).
  15. Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride: 8 Fluoride. Washington, DC: National Academies Press 1997. https://www.ncbi.nlm.nih.gov/books/NBK109832/. Accessed July 6, 2021.
  16. Clark MB, Slayton RL. Fluoride use in caries prevention in the primary care setting. Pediatrics 2014;134(3):626-33.
  17. Levy SM. An update on fluorides and fluorosis. J Can Dent Assoc 2003;69(5):286-91.
  18. 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.
  19. Thornton-Evans G, Junger ML, Lin M, et al. Use of Toothpaste and Toothbrushing Patterns Among Children and Adolescents - United States, 2013-2016. MMWR Morb Mortal Wkly Rep 2019;68(4):87-90.
  20. American Dental Association Council on Scientific Affairs. Fluoride Toothpaste Use for Young Children. J Am Dent Assoc 2014;145(2):190-91.
  21. 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.
  22. Abrasivity of current dentifrices. Council on Dental Therapeutics. J Am Dent Assoc 1970;81(5):1177-8.
  23. 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.
  24. St John S, White DJ. History of the Development of Abrasivity Limits for Dentifrices. J Clin Dent 2015;26(2):50-4.
  25. 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.
  26. American National Standards Institute ADA. ANSI/ADA Standard No. 130 for Dentifrices. American National Standards Institute, American Dental Association. Chicago: American Dental Association. 2020.
  27. U.S. Food & Drug Administration. Code of Federal Regulations (CFR) Title 21; 2006. p. 300-04.
 

Topic last updated: July 8, 2021

Prepared by:

Department of Scientific Information, Evidence Synthesis & Translation Research, ADA Science & Research Institute, LLC.


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