| Fluoride mouthrinse compared with placebo or no treatment for preventing caries in children and adolescents |
| Patient or population: children and adolescents
Setting: community (schools)
Intervention: fluoride mouthrinse (primarily supervised use in school setting)
Comparison: placebo or no treatment |
| Changes in caries on the surfaces of permanent teeth measured by D(M)FS increment ‐ nearest to 3 years | Mean increment ranged across control groups from 0.74 to 21.05, median 5.6 | The corresponding mean increment in the intervention group is 3.80 (95% CI 3.64 to 4.00) | PFa 0.27
(0.23 to 0.30) | 15305
(35 RCTs) | ⊕⊕⊕⊝
moderateb | Large effect: D(M)FS PF 27% (23% to 30%) |
| Changes in caries on the permanent teeth measured by D(M)FT increment ‐ nearest to 3 years | Mean increment ranged across control groups from 0.72 to 8.41, median 3.2 | The corresponding mean increment in the intervention group is 2.46 (95% CI 2.27 to 2.62) | PFa 0.23
(0.18 to 0.29) | 5105
(13 RCTs) | ⊕⊕⊕⊝
moderateb | Moderate to large effect: D(M)FT PF 23% (18% to 29%) |
| Unacceptability of treatment as measured by leaving study early | 149 per 1000 | 198 per 1000
(92 to 422) | RR 1.33
(0.62 to 2.83) | 1700
(4 RCTs) | ⊕⊝⊝⊝
very lowb,c,d | |
| Tooth staining | Study 1: "significant difference" in stain score (from the control) in the group using an amine fluoride mouthrinse: "non‐significant difference" (from the control) in the group using sodium fluoride In 2 trials where stannous fluoride mouthrinsing was tested against placebo rinsing: Study 2: "approximately six children had tenacious staining that required a rubber cup prophylaxis carried out" ‐ no indication as to which groups these children belonged Study 3: "some amount of yellow pigmentation, somewhat more noticeable in the children in the test group" | | | Study 1: 525 Study 2: 743 Study 3: 726 | ⊕⊝⊝⊝ very lowe | We know little about the risk of tooth staining owing to incomplete reporting |
| Signs of acute toxicity during application of treatment (such as nausea/gagging/vomiting) | Not reported in any studies | No data on signs of acute toxicity |
| Mucosal irritation/oral soft tissue allergic reaction | "no cases of mucosal hypersensitivity after periodical examinations of every subject" ‐ reported in 1 study | 434 (1 RCT) | ⊕⊝⊝⊝ very lowe | We know very little about the risk of mucosal irritation/allergic reaction owing to lack of reporting |
| *The basis for the assumed risk, the risk in the placebo or no treatment group, was the range and median in the control groups of the studies included in the review. Thecorresponding risk, the risk in the intervention group(and its 95% confidence interval), is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI = confidence interval; D(M)FS = decayed (missing) and filled permanent surfaces; D(M)FT = decayed (missing) and filled permanent teeth; PF = prevented fraction; RR = risk ratio |
| GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
