Cochrane · intervention · CD002278
Fluoride toothpastes for preventing dental caries in children and adolescents
Marinho, VCC, Higgins, J, 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
7
current version
GRADE rated
0
No studies
1
Included studies
74
as reported
No studies 1 · 14.3%Ungraded 6 · 85.7%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 caries level, background fluoride exposure, dental treatment level, nationality or setting; studies selecting participants on the basis of special general or oral health conditions were excluded. | 45,073 children aged 5 to 16 years at start (38,868 analysed at end); baseline D(M)FS ranged 0.97 to 17.4; some background fluoride exposure in 13 trials, none in 46, unclear in 15; participants recruited mainly from schools (5 trials in orphanages/institutions). |
| Intervention | Topical fluoride in the form of toothpaste only, using any fluoride agent (sodium fluoride NaF, sodium monofluorophosphate SMFP, stannous fluoride SnF2, acidulated phosphate fluoride APF, amine fluoride AmF), at any concentration (ppm F), frequency, amount or duration, with any brushing technique. | Sodium monofluorophosphate SMFP (n=27); Stannous fluoride SnF2 (n=29); Sodium fluoride NaF (n=14); Amine fluoride AmF (n=8); Acidulated phosphate fluoride APF (n=5); Mixed agents (n=5); fluoride concentration 250 to 2500 ppm F, with 1000/1100 ppm F tested in at least 56 trials. |
| Comparison | Placebo (non-fluoride) toothpaste. | Placebo (non-fluoride) toothpaste (n=74). |
| Outcomes | Primary: caries increment measured as change from baseline in decayed, (missing) and filled tooth surfaces D(M)FS (permanent teeth). Also relevant: coronal caries and fillings in permanent and deciduous dentitions; tooth loss; dental pain/discomfort; specific side effects (fluorosis, tooth staining/discolouration, oral allergic reactions, adverse symptoms such as nausea/vomiting); use of health service resources. | Caries increment D(M)FS permanent (n=71); Caries increment D(M)FT permanent (n=53); Caries increment/df-rate deciduous (n=1); Caries incidence/attack rate (n=13); Caries progression (n=5); Proportion of children developing new caries (n=7); Proportion of children not remaining caries-free (n=2); Tooth staining (n=12); Oral soft tissue lesions (n=3). |
| Study designs | Randomised or quasi-randomised controlled trials (RCTs) using or indicating blind outcome assessment. | 74 RCTs/quasi-RCTs; allocation concealment adequate (A) in 11 trials, unclear (B) in 56, quasi-randomised (C) in 7; blind outcome assessment with placebo (double-blind, A) in all but 2 trials (blinding unclear but indicated). |
| Timing | At least 1 year/school year. | Study duration ranged from 1 to 7 years: 7 trials lasted 4 years or more, 36 lasted 3 years, 27 around 2 years, and 4 lasted 1 to 1.5 years; 3-year follow up most common (44 trials). |
Search date: 2001-10. Databases: Cochrane Oral Health Group's Trials Register; CENTRAL; MEDLINE; EMBASE; SCISEARCH; SSCISEARCH; ISTP; BIOSIS; CINAHL; ERIC; DISSERTATION ABSTRACTS; LILACS/BBO; SIGLE; NIDR/Community of Science Database; OLDMEDLINE; meta Register of Controlled Trials
Questions and results
Fluoride toothpaste vs Placebo (non-fluoride) toothpaste
Population: Children and adolescents aged 16 years or less
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Proportion of children developing one or more new caries At least 1 year | RR 0.91 [0.80, 1.04] | 7 studies · 2878 participants | Ungraded |
Acquiring extrinsic tooth staining (adverse effect; stannous fluoride toothpaste) At least 1 year | RD 0.24 [0.19, 0.30] | 5 studies · 3948 participants | Ungraded |
Enamel fluorosis (adverse effect) At least 1 year | Fluorosis data have not been reported in any of the trials. | 0 studies | No studies |
Caries increment in permanent teeth: decayed, (missing) and filled tooth surfaces D(M)FS (prevented fraction) At least 1 year | PF 0.24 [0.21, 0.28] | 70 studies · 42300 participants | Ungraded |
Caries increment in deciduous teeth: df-rate, new decayed or filled teeth per 100 primary teeth (prevented fraction) At least 1 year · Deciduous dentition | PF 0.37 | 1 study · 2008 participants | Ungraded |
Caries increment in permanent teeth: decayed, (missing) and filled teeth D(M)FT (prevented fraction) At least 1 year | PF 0.23 [0.18, 0.28] | 53 studies · 32371 participants | Ungraded |
Oral soft tissue lesions (adverse effect) At least 1 year | Oral soft tissue lesions reported in 3 trials, none of which with complete or useable data; all three stated "no lesions attributable to product use were noted". | 3 studies | Ungraded |