Topical fluoride as a cause of dental fluorosis in children

Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD007693. doi: 10.1002/14651858.CD007693.pub2.


Background: For many years, topical use of fluorides has gained greater popularity than systemic use of fluorides. A possible adverse effect associated with the use of topical fluoride is the development of dental fluorosis due to the ingestion of excessive fluoride by young children with developing teeth.

Objectives: To describe the relationship between the use of topical fluorides in young children and the risk of developing dental fluorosis.

Search strategy: Electronic search of the Cochrane Oral Health Group Trials Register, CENTRAL, MEDLINE, EMBASE, BIOSIS, Dissertation Abstracts and LILACS/BBO. Reference lists from relevant articles were searched. Date of the most recent searches: 9th March 09.

Selection criteria: Randomised controlled trials (RCTs), quasi-RCTs, cohort studies, case-control studies and cross-sectional surveys, in which fluoride toothpastes, mouthrinses, gels, foams, paint-on solutions, and varnishes were compared to an alternative fluoride treatment, placebo or no intervention group. Children under the age of 6 years at the time topical fluorides were used.

Data collection and analysis: Data from all included studies were extracted by two review authors. Risk ratios for controlled, prospective studies and odds ratios for case-control studies or cross-sectional surveys were extracted or calculated. Where both adjusted and unadjusted risk ratios or odds ratios were presented, the adjusted value was included in the meta-analysis.

Main results: 25 studies were included: 2 RCTs, 1 cohort study, 6 case-control studies and 16 cross-sectional surveys. Only one RCT was judged to be at low risk of bias. The other RCT and all observational studies were judged to be at moderate to high risk of bias. Studies were included in four intervention/exposure comparisons. A statistically significant reduction in fluorosis was found if brushing of a child's teeth with fluoride toothpaste commenced after the age of 12 months odds ratio 0.70 (random-effects: 95% confidence interval 0.57 to 0.88) (data from observational studies). Inconsistent statistically significant associations were found between starting using fluoride toothpaste/toothbrushing before or after the age of 24 months and fluorosis (data from observational studies). From the RCTs, use of higher level of fluoride was associated with an increased risk of fluorosis. No significant association between the frequency of toothbrushing or the amount of fluoride toothpaste used and fluorosis was found.

Authors' conclusions: There should be a balanced consideration between the benefits of topical fluorides in caries prevention and the risk of the development of fluorosis. Most of the available evidence focuses on mild fluorosis. There is weak unreliable evidence that starting the use of fluoride toothpaste in children under 12 months of age may be associated with an increased risk of fluorosis. The evidence for its use between the age of 12 and 24 months is equivocal. If the risk of fluorosis is of concern, the fluoride level of toothpaste for young children (under 6 years of age) is recommended to be lower than 1000 parts per million (ppm).More evidence with low risk of bias is needed. Future trials assessing the effectiveness of different types of topical fluorides (including toothpastes, gels, varnishes and mouthrinses) or different concentrations or both should ensure that they include an adequate follow-up period in order to collect data on potential fluorosis. As it is unethical to propose RCTs to assess fluorosis itself, it is acknowledged that further observational studies will be undertaken in this area. However, attention needs to be given to the choice of study design, bearing in mind that prospective, controlled studies will be less susceptible to bias than retrospective and/or uncontrolled studies.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Age Factors
  • Cariostatic Agents / adverse effects*
  • Child, Preschool
  • Fluorides / adverse effects*
  • Fluorosis, Dental / etiology*
  • Humans
  • Infant
  • Toothpastes / adverse effects*


  • Cariostatic Agents
  • Toothpastes
  • Fluorides