Cochrane · intervention · CD002280
Fluoride gels for preventing dental caries in children and adolescents
Marinho, VCC, Worthington, HV, Walsh, T, et al. · Cochrane Database of Systematic Reviews · 2015 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
17
current version
GRADE rated
3
No studies
3
Included studies
28
as reported
No studies 3 · 17.6%Ungraded 11 · 64.7%Very low 1 · 5.9%Low 1 · 5.9%Moderate 1 · 5.9%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 caries level, background fluoride exposure, dental treatment level, nationality, setting or start time; studies selecting participants on the basis of special (general or oral) health conditions were excluded | All 28 trials reported participants aged 15 years or less at start (range 2 to 15 years); 15 trials included 12-year-olds at start and 3 trials included children younger than 6; total 9140 children (range 41 to 732 per trial); recruited mostly from schools |
| Intervention | Topical fluoride in the form of gels only, operator- or self-applied, using any fluoride agent, at any concentration (ppm F), amount or duration of application, with any technique (prior to or post application); frequency of application at least once a year | Acidulated Phosphate Fluoride (n=21); Sodium Fluoride (n=7); Amine Fluoride (n=5); Stannous Fluoride (n=1) |
| Comparison | Placebo (for any method of gel application) or no treatment (for tray or cotton-tips methods of gel application, but not for brushing or flossing methods) | Placebo (n=18); No treatment (n=10) |
| Outcomes | Primary: caries increment as change from baseline in permanent D(M)FS and primary d(e/m)fs (and D(M)FT/d(e/m)ft where reported). Secondary: development of new caries; children not remaining caries-free; tooth staining; signs of acute toxicity during application (nausea, gagging, vomiting); mucosal irritation/oral soft-tissue allergic reaction; overall dropouts or withdrawals | D(M)FS increment (n=25); D(M)FT increment (n=10); d(e/m)fs increment (n=3); Development of new caries (n=1); Children not remaining caries-free (n=2); Signs of acute toxicity nausea/vomiting (n=2); Dropouts or withdrawals (n=19) |
| Study designs | Randomised or quasi-randomised controlled trials with stated or indicated blind outcome assessment and follow-up of at least 1 year/school year; cluster-randomised trials included (except when only one cluster per group); split-mouth studies excluded | All parallel-group trials (one cluster-randomised); 20 at high and 8 at unclear risk of bias; 5 acknowledged manufacturer funding, 7 some manufacturer assistance/supply, 7 non-commercial grants |
| Timing | At least 1 year/school year | Study duration 1 to 4 years: 3 trials 4 years; 9 trials 3 years; 11 trials around 2 years; 2 trials 1.5 years; 2 trials 1 year |
Search date: 2014-11. Databases: Cochrane Oral Health Group Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via OVID; EMBASE via OVID; CINAHL via EBSCO; LILACS via BIREME Virtual Health Library; BBO via BIREME Virtual Health Library; ProQuest Dissertations and Theses; Web of Science Conference…
Questions and results
Current version onlyFluoride gel (topically applied; operator- or self-applied; any fluoride agent/concentration; frequency at least once a year) vs Placebo or no treatment
Population: Children and adolescents aged 16 years or younger
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mucosal irritation / oral soft-tissue allergic reaction | None of the studies reported this outcome. | 0 studies | No studies |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · Placebo-controlled trials Population: Children and adolescents aged 16 years or younger (permanent dentition) | PF 0.18 [0.09, 0.27] | 4 studies | Ungraded |
Proportion of children not remaining caries-free Primary dentition Population: Children with primary (deciduous) teeth (mostly preschool children aged under 6 years) | RR 0.53 [0.26, 1.07] | 1 study · 145 participants | Ungraded |
Signs of acute toxicity during gel application (nausea, gagging, vomiting) During gel application | RD 0.01 [-0.01, 0.02] 10 [-10, 20] per 1000 (more with fluoride gel) | 2 studies · 490 participants | Very low Downgraded: risk of bias, imprecision |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years Population: Children and adolescents aged 16 years or younger (permanent dentition) | PF 0.32 [0.19, 0.46] | 10 studies | Ungraded |
Unacceptability of treatment (dropouts/exclusions during the trial) During trial | RR 1.03 [0.89, 1.19] | 19 studies | Ungraded |
Caries increment on primary (deciduous) tooth surfaces (d(e/m)fs), prevented fraction Nearest to 3 years Population: Children with primary (deciduous) teeth (mostly preschool children aged under 6 years) | PF 0.20 [0.01, 0.38] -0.52 [-0.88, -0.17] d(m)fs surfaces (mean increment; fewer with fluoride gel) | 3 studies · 1254 participants | Low Downgraded: imprecision, indirectness, publication bias |
Unacceptability of treatment (dropouts/exclusions during the trial) During trial · No-treatment-controlled trials | RR 1.03 [0.73, 1.47] | 8 studies · 2628 participants | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · Placebo-controlled trials Population: Children and adolescents aged 16 years or younger (permanent dentition) | PF 0.21 [0.15, 0.28] | 15 studies · 5671 participants | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · No-treatment-controlled trials Population: Children and adolescents aged 16 years or younger (permanent dentition) | PF 0.38 [0.24, 0.52] | 10 studies · 2808 participants | Ungraded |
Tooth staining | None of the studies reported on staining of tooth surfaces (not even Gisselsson 1999, the only trial testing stannous fluoride). | 0 studies | No studies |
Proportion of children developing new caries Population: Children and adolescents aged 16 years or younger (permanent dentition) | RR 0.82 [0.68, 0.99] | 1 study · 280 participants | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years Population: Children and adolescents aged 16 years or younger (permanent dentition) | PF 0.28 [0.19, 0.36] -0.27 [-0.37, -0.18] D(M)FS surfaces (mean increment; fewer with fluoride gel) | 25 studies · 8479 participants | Moderate Downgraded: risk of bias |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · No-treatment-controlled trials Population: Children and adolescents aged 16 years or younger (permanent dentition) | PF 0.43 [0.29, 0.57] | 6 studies | Ungraded |
Caries increment on primary (deciduous) whole teeth (d(m)ft), prevented fraction Nearest to 3 years Population: Children with primary (deciduous) teeth (mostly preschool children aged under 6 years) | There were no data on d(m)ft available. | 0 studies | No studies |
Unacceptability of treatment (dropouts/exclusions during the trial) During trial · Placebo-controlled trials | RR 1.05 [0.91, 1.22] | 11 studies · 6067 participants | Ungraded |
Proportion of children not remaining caries-free Permanent dentition Population: Children and adolescents aged 16 years or younger (permanent dentition) | RR 0.72 [0.46, 1.14] | 1 study · 280 participants | Ungraded |
Fluoride gel (topically applied; operator- or self-applied; any fluoride agent/concentration; frequency at least once a year) vs Placebo or no treatment
Population: Children and adolescents aged 16 years or younger (permanent dentition)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · Placebo-controlled trials | PF 0.18 [0.09, 0.27] | 4 studies | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years | PF 0.28 [0.19, 0.37] | 23 studies | Ungraded |
Caries increment on primary (deciduous) tooth surfaces (d(e/m)fs), prevented fraction Nearest to 3 years Population: Children with primary (deciduous) teeth (mostly preschool children aged under 6 years) | Not pooled (neither trial provided standard deviations). Treide 1988 reported a defs PF of 0.39 (CI not obtainable); Englander 1978 reported equivocal results (no demonstrated effect of fluoride gel). | 2 studies | Ungraded |
Proportion of children not remaining caries-free Population: Children and adolescents aged 16 years or younger | RR 0.66 [0.45, 0.97] | 2 studies | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · No-treatment-controlled trials | PF 0.38 [0.24, 0.53] | 9 studies | Ungraded |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years | PF 0.32 [0.19, 0.46] | 10 studies | Ungraded |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · No-treatment-controlled trials | PF 0.43 [0.29, 0.57] | 6 studies | Ungraded |
Signs of acute toxicity during gel application (nausea, gagging, vomiting) During gel application Population: Children and adolescents aged 16 years or younger | RD 0.01 [-0.01, 0.02] | 2 studies | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · Placebo-controlled trials | PF 0.21 [0.14, 0.28] | 14 studies | Ungraded |
Unacceptability of treatment (dropouts/exclusions during the trial) During trial · No-treatment-controlled trials Population: Children and adolescents aged 16 years or younger | RR 1.09 [0.70, 1.72] | 6 studies | Ungraded |
Proportion of children developing new caries | RR 0.82 [0.68, 0.99] | 1 study | Ungraded |