Cochrane · intervention · CD002782
Topical fluoride (toothpastes, mouthrinses, gels or varnishes) for preventing dental caries in children and adolescents
Marinho, VCC, Higgins, JPT, Logan, S, et al. · Cochrane Database of Systematic Reviews · 2003 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
23
current version
GRADE rated
0
No studies
1
Included studies
144
as reported
No studies 1 · 4.3%Ungraded 22 · 95.7%Very low 0 · 0%Low 0 · 0%Moderate 0 · 0%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 less at the start of the study, irrespective of initial dental 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 | 144 trials involving over 65,000 children (65,169 in the 133 D(M)FS meta-analysis trials); most conducted in industrialized countries (USA, UK, Europe, Scandinavia), at least 14 elsewhere; studies generally large (only 15 allocated fewer than 100 children), nearly all recruited from schools; trials conducted 1954 to 1996 |
| Intervention | Topical fluoride therapy in the form of toothpastes, mouthrinses, gels or varnishes only, using any fluoride agent (any compatible abrasive system for toothpastes), at any concentration (ppm F), amount or duration of application, with any technique/method of application; frequency of application at least once a year | Fluoride toothpaste (n=74); Fluoride mouthrinse (n=36); Fluoride gel (n=25); Fluoride varnish (n=9) |
| Comparison | Placebo (for any method of fluoride application) or no treatment (except for brushing or flossing methods of application) | Placebo (n=125); No treatment (n=19) |
| Outcomes | Primary: caries increment measured by change from baseline in D(M)FS (permanent) and d(e/m)fs (deciduous). Also relevant: coronal caries and fillings in permanent and deciduous dentitions; tooth loss; proportion of children developing new caries; dental pain/discomfort; specific side effects (fluorosis, tooth staining/discoloration, oral allergic reactions, adverse symptoms such as nausea/vomiting); unacceptability of treatment (dropouts); use of health service resources | D(M)FS increment (n=133); D(M)FT increment (n=79); d(e/m)fs increment (n=5); Proportion of children developing new caries (n=13); Unacceptability of treatment/drop outs (n=10) |
| Study designs | Randomised or quasi-randomised controlled trials using or indicating blind outcome assessment, comparing one form of TFT (toothpaste, mouthrinse, gel or varnish) concurrently to a placebo or no TFT group for at least 1 year/school year; split-mouth/within-group paired designs, open outcome assessment, and trials under 1 year were excluded | All randomised or quasi-randomised parallel-group trials (109 described as randomised without adequate detail, 21 quasi-randomised; 118 double-blind, 14 single-blind, 12 blinding indicated); 2 cluster-randomised trials; 5 trials contributed no data for meta-analysis |
| Timing | At least 1 year/school year | Study duration ranged from 1 to 6 years (great majority 2 or 3 years); trials conducted between 1954 and 1996 (three in the 1950s, most in the 1960s-1970s, 16 in the 1980s, four in the 1990s) |
Search date: 2001-10. Databases: MEDLINE; EMBASE; SCISEARCH; SSCISEARCH; ISTP; BIOSIS; CINAHL; ERIC; DISSERTATION ABSTRACTS; LILACS; BBO; CENTRAL (The Cochrane Library); SIGLE; OLDMEDLINE; Community of Science database; meta Register of Current Controlled Trials; Cochrane Oral Health Group's Trials Register
Questions and results
Topical fluoride therapy (toothpaste, mouthrinse, gel or varnish; 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 tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · Placebo-controlled trials | PF 0.24 [0.22, 0.27] | 116 studies | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · Fluoride gel trials | PF 0.28 [0.19, 0.37] | 22 studies | Ungraded |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · Fluoride gel trials | PF 0.32 [0.19, 0.46] | 10 studies | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · No-treatment-controlled trials | PF 0.40 [0.31, 0.49] | 17 studies | Ungraded |
Caries increment on primary (deciduous) tooth surfaces (d(e/m)fs), prevented fraction Nearest to 3 years · Fluoride gel trials Population: Children with primary (deciduous) teeth (younger children) | PF 0.26 [-0.11, 0.63] | 2 studies | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · Fluoride toothpaste trials | PF 0.24 [0.21, 0.28] | 70 studies | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years | PF 0.26 [0.23, 0.29] | 133 studies · 65169 participants | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · Fluoride mouthrinse trials | PF 0.26 [0.23, 0.30] | 34 studies | Ungraded |
Caries increment on permanent tooth surfaces (D(M)FS), prevented fraction Nearest to 3 years · Fluoride varnish trials | PF 0.46 [0.30, 0.63] | 7 studies | Ungraded |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · Fluoride varnish trials | PF 0.53 [0.23, 0.82] | 3 studies | Ungraded |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · No-treatment-controlled trials | PF 0.45 [0.32, 0.58] | 7 studies | Ungraded |
Caries increment on primary (deciduous) tooth surfaces (d(e/m)fs), prevented fraction Nearest to 3 years · No-treatment-controlled trials Population: Children with primary (deciduous) teeth (younger children) | PF 0.41 [0.26, 0.55] | 2 studies | Ungraded |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years | PF 0.26 [0.21, 0.30] | 79 studies | Ungraded |
Adverse effects (tooth staining/discoloration, oral soft-tissue signs, adverse symptoms such as nausea/vomiting, enamel etching) Population: Children and adolescents aged 16 years or younger | Data on adverse effects (stain score, proportion of children with tooth staining, signs of sensitivity in oral soft tissue, adverse symptoms such as nausea/vomiting, etching of enamel) were reported in only a few… | NR | Ungraded |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · Fluoride mouthrinse trials | PF 0.24 [0.18, 0.30] | 13 studies | Ungraded |
Dental fluorosis Population: Children and adolescents aged 16 years or younger | Fluorosis data have not been reported in any of the trials. | 0 studies | No studies |
Caries increment on primary (deciduous) tooth surfaces (d(e/m)fs), prevented fraction Nearest to 3 years · Placebo-controlled trials Population: Children with primary (deciduous) teeth (younger children) | PF 0.27 [0.08, 0.48] | 3 studies | Ungraded |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · Placebo-controlled trials | PF 0.24 [0.20, 0.28] | 72 studies | Ungraded |
Caries increment on permanent whole teeth (D(M)FT), prevented fraction Nearest to 3 years · Fluoride toothpaste trials | PF 0.23 [0.19, 0.28] | 53 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 (younger children) | PF 0.33 [0.22, 0.44] | 5 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 1.20 [0.85, 1.70] | 10 studies | Ungraded |
Proportion of children developing one or more new caries | RR 0.88 [0.82, 0.95] | 13 studies | Ungraded |
Caries increment on primary (deciduous) tooth surfaces (d(e/m)fs), prevented fraction Nearest to 3 years · Fluoride varnish trials Population: Children with primary (deciduous) teeth (younger children) | PF 0.33 [0.19, 0.48] | 3 studies | Ungraded |