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Topical fluoride (toothpastes, mouthrinses, gels or varnishes) for preventing dental caries in children and adolescents

  • Review
  • Intervention




Topical fluoride therapy (TFT) in the form of varnish, gel, mouthrinse or toothpaste has been used extensively as a caries-preventive intervention for over 3 decades.


To determine the effectiveness and safety of fluoride varnishes, gels, mouthrinses, and toothpastes in the prevention of dental caries in children and to examine factors potentially modifying their effect.

Search methods

We searched the Cochrane Oral Health Group's Trials Register (May 2000), CENTRAL (The Cochrane Library 2000, Issue 2), MEDLINE (1966 to January 2000), plus several other databases. We handsearched journals, reference lists of articles and contacted selected authors and manufacturers.

Selection criteria

Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish, gel, mouthrinse, or toothpaste with placebo or no treatment in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS).

Data collection and analysis

Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF) that is the difference in mean caries increments between the treatment and control groups expressed as a percentage of the mean increment in the control group. Random-effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random-effects metaregression analyses.

Main results

There were 144 studies included. For the 133 that contributed data for meta-analysis (involving 65,169 children) the D(M)FS pooled prevented fraction estimate was 26% (95% CI, 24% to 29%; P < 0.0001). There was substantial heterogeneity, confirmed statistically (P < 0.0001), but the direction of effect was consistent. The effect of topical fluoride varied according to type of control group used, type of TFT used, mode/setting of TFT use, initial caries levels and intensity of TFT application, but was not influenced by exposure to water fluoridation or other fluoride sources. D(M)FS PF was on average 14% (95% CI, 5% to 23%; P = 0.002) higher in non-placebo controlled trials, 14% (95% CI, 2% to 26%; P = 0.25) higher in fluoride varnish trials compared with all others, and 10% (95% CI, -17% to -3%; P = 0.003) lower in trials of unsupervised home use compared with self applied supervised and operator-applied. There was a 0.7% increase in the PF per unit increase in baseline caries (95% CI, 0.2% to 1.2%; P = 0.004).

Authors' conclusions

The benefits of topical fluorides have been firmly established on a sizeable body of evidence from randomized controlled trials. While the formal examination of sources of heterogeneity between studies has been important in the overall conclusions reached, these should be interpreted with caution. We were unable to reach definite conclusions about any adverse effects that might result from the use of topical fluorides, because data reported in the trials are scarce.








我們搜尋了Cochrane Oral Health Group's Trials Register (May 2000), CENTRAL (The Cochrane Library Issue 2, 2000), MEDLINE (1966 to January 2000),加上數種電子資料庫.我們也查閱了期刊,文章的參考文獻資料,聯絡作者及相關的廠商.




將這些研究的三分之一隨機樣本重複進行資料的列入決定,品質評估和資料提取,並且經討論或第三方達成共識.缺少的資料向研究作者取得.對於效果的初步評估方法是以預防分數(prevented fraction, PF)來看, 預防分數指的是在治療組和控制組蛀牙增加率的差異和控制組蛀牙增加率的比值,以百分比表示.隨機的效果meta分析在資料彙集後進行.異質性可能產生的原因可在隨機的效果meta迴歸分析中審視.


本研究包含了144個研究.有133個研究提供資料進行meta分析(共包含65,169個孩童),以收集到的蛀牙.脫落.填補牙面計算得到的預防分數為26%(95% CI, 24% to 29%; p < 0.0001),有明顯的異質性並有統計上的意義,但影響的方向是一致的.局部氟化物的效果依控制組使用的類型,使用局部氟化物的種類.方法和強度,及孩童原本的蛀牙情況而不同,但並不受到飲水加氟和其他氟化物使用的影響.非安慰劑的控制組得到的蛀牙.脫落.填補牙面計算出預防分數在非安慰劑控制組試驗的平均為14%以上(95% CI, 5% to 23%; p = 0.002);使用氟化塗漆和其他種類比較起來可以達到預防分數14%以上(95% CI, 2% to 26%; p = 0.25);在家未經監督使用與在監督下自己使用或醫師使用比較,得到其預防分數為10%以下(95% CI, −17% to −3%; p = 0.003).蛀牙每增加一單位時,預防分數增加0.7%(95% CI, 0.2% to 1.2%; p = 0.004).





此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。



Plain language summary

Topical fluoride (toothpastes, mouthrinses, gels or varnishes) for preventing dental caries in children and adolescents

The use of fluoride toothpastes, mouthrinses, gels or varnishes reduces tooth decay in children and adolescents.
Tooth decay (dental caries) is painful, expensive to treat and can seriously damage teeth. Fluoride is a mineral that prevents tooth decay. The review of trials found that children aged 5 to 16 years who applied fluoride in the form of toothpastes, mouthrinses, gels or varnishes had fewer decayed, missing and filled teeth regardless of whether their drinking water was fluoridated. Supervised use of self applied fluoride increases the benefit. Fluoride varnishes may have a greater effect but more high quality research is needed to be sure of how big a difference these treatments make, and whether they have adverse effects.