Cochrane · intervention · CD002284
Fluoride mouthrinses for preventing dental caries in children and adolescents
Marinho, VCC, Chong, L-Y, Worthington, HV, et al. · Cochrane Database of Systematic Reviews · 2016 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
9
current version
GRADE rated
5
No studies
3
Included studies
37
as reported
No studies 3 · 33.3%Ungraded 1 · 11.1%Very low 3 · 33.3%Low 0 · 0%Moderate 2 · 22.2%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Children or adolescents aged 16 or younger at the start of the study (irrespective of initial level of dental caries, background exposure to fluorides, dental treatment level, nationality, setting or time when intervention started); studies selecting participants on the basis of special general or oral health conditions were excluded. | Children aged 14 or younger at start (range 5 to 14 years); at least 18 trials included 12-year-olds, at least 5 included 6-year-olds (no primary-teeth caries data); baseline caries prevalence 0.94 to 14.6 D(M)FS; 15,813 children total across 37 trials (95 to 1238 per trial, mean 427). |
| Intervention | Topical fluoride in the form of a mouthrinse that is swished and expectorated, not swallowed; included irrespective of formulation, concentration (ppm F), volume, duration, frequency or technique of application. | Sodium fluoride (n=33); Acidulated phosphate fluoride (n=4); Stannous fluoride (n=2); Sodium monofluorophosphate (n=1); Amine fluoride (n=1); Ammonium fluoride (n=1) |
| Comparison | Placebo; No treatment | Placebo (n=32); No treatment (n=5) |
| Outcomes | Primary: caries increment in permanent tooth surfaces D(M)FS (and D(M)FT) and in primary tooth surfaces d(e)fs (and d(e)ft), as change from baseline. Secondary: development of new caries; children not remaining caries-free; tooth staining; signs of acute toxicity (nausea/gagging/vomiting); mucosal irritation/oral soft tissue allergic reaction; dropouts/withdrawals (acceptability). | Caries increment D(M)FS (n=35); Caries increment D(M)FT (n=13); Proportion of children developing new caries (n=3); Tooth staining (n=3); Mucosal irritation/oral soft tissue allergic reaction (n=1); Signs of acute toxicity (n=0); Not remaining caries-free (n=0); Unacceptability of treatment/dropouts (n=4); Caries increment deciduous (n=0) |
| Study designs | Randomised or quasi-randomised controlled trials where blind outcome assessment was stated or indicated; cluster-randomised trials included except when only one cluster was assigned per group; split-mouth studies excluded. | RCT or quasi-RCT (n=37), including one cluster-randomised trial (Ruiken 1987); 28 trials at high risk of bias, 9 at unclear risk of bias |
| Timing | At least 1 year/school year | Study duration 2 to 3 years (three trials 1.6 years); follow-up of 2 or 3 years in 26 trials |
Search date: 2016-04. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; CINAHL EBSCO; LILACS BIREME; BBO BIREME; Proquest Dissertations and Theses; Web of Science Conference Proceedings; US National Institutes of Health Trials Register…
Questions and results
Show all 2 versionsFluoride mouthrinse (any fluoride agent, concentration, volume, frequency or technique; swished and expectorated, not swallowed) vs Placebo or no treatment
Population: Children or adolescents aged 16 years or younger at the start of the study
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Signs of acute toxicity during application of treatment (such as nausea/gagging/vomiting) At least 1 year/school year | 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". None of the studies reported adverse acute symptoms… | 0 studies | No studies |
Mucosal irritation / oral soft tissue allergic reaction (signs of sensitivity) At least 1 year/school year | One trial (Rugg-Gunn 1973) reported incompletely on oral soft tissue irritation/signs of sensitivity (allergic reaction): "no cases of mucosal hypersensitivity after periodical examinations of every subject". 434… | 1 study · 434 participants | Very low Downgraded: risk of bias, imprecision |
Caries increment in deciduous (primary) teeth/surfaces (d(e/m)fs; dmf index) At least 1 year/school year | We could not present estimates of the effect of fluoride mouthrinse on caries increment in deciduous teeth/tooth surfaces (dmf index) as no study contributed data. None of the included trials reported on caries… | 0 studies | No studies |
Proportion of children developing one or more new caries At least 1 year/school year | RR 0.77 [0.46, 1.29] | 3 studies · 1805 participants | Ungraded |
Unacceptability of treatment as measured by leaving study early (dropouts) At least 1 year/school year | RR 1.33 [0.62, 2.83] 149 per 1000 vs 198 per 1000 | 4 studies · 1700 participants | Very low Downgraded: risk of bias, imprecision, inconsistency |
Caries increment in permanent teeth: decayed, (missing) and filled teeth D(M)FT (prevented fraction) At least 1 year/school year | PF 0.23 [0.18, 0.29] Mean increment ranged across control groups from 0.72 to 8.41, median 3.2 vs 2.46 | 13 studies · 5105 participants | Moderate Downgraded: risk of bias |
Caries increment in permanent teeth: decayed, (missing) and filled tooth surfaces D(M)FS (prevented fraction) At least 1 year/school year | PF 0.27 [0.23, 0.30] Mean increment ranged across control groups from 0.74 to 21.05, median 5.6 vs 3.80 | 35 studies · 15305 participants | Moderate Downgraded: risk of bias |
Proportion of children not remaining caries-free At least 1 year/school year | None of the trials reported data on the proportion of children not remaining caries-free. | 0 studies | No studies |
Tooth staining/discolouration (adverse effect) At least 1 year/school year | 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… | 3 studies | Very low Downgraded: risk of bias, imprecision |