Cochrane · intervention · CD002781

Combinations of topical fluoride (toothpastes, mouthrinses, gels, varnishes) versus single topical fluoride for preventing dental caries in children and adolescents

Marinho, VCC, Higgins, JPT, Sheiham, A, et al. · Cochrane Database of Systematic Reviews · 2004 · Cochrane Library

Oral HealthDental caries2 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
18
current version
GRADE rated
0
No studies
1
Included studies
12
as reported
No studies 1 · 5.6%Ungraded 17 · 94.4%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

ElementPlanned (methods)Found (results)
PopulationChildren 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); those selected on the basis of special general or oral health conditions excludedChildren aged 14 or less at start in all trials, mostly around 12 years, one trial in preschool children; baseline caries 1-10 D(M)FS (0.9 dfs in the preschool trial); only one trial in a fluoridated community (n=12)
InterventionTopical fluoride therapy as toothpastes, mouthrinses, gels or varnishes (any fluoride agent, any concentration, amount, duration or technique, frequency at least once a year) used in combinationFluoride toothpaste + mouthrinse (n=5); fluoride toothpaste + gel (n=3); fluoride toothpaste + varnish (n=2); fluoride gel + mouthrinse (n=2); fluoride mouthrinse + gel (n=1)
ComparisonA single topical fluoride modality alone (mainly fluoride toothpaste)Fluoride toothpaste alone (n=9 across subgroups); fluoride mouthrinse alone (n=5); fluoride gel alone (n=4); fluoride varnish alone (n=1)
OutcomesPrimary: caries increment (change in D(M)FS permanent; d(e/m)fs deciduous) at the dentin level; Relevant: coronal caries and fillings (permanent and deciduous); tooth loss; proportion of children developing new caries; dental pain/discomfort; specific side effects (fluorosis, tooth staining/discoloration, oral allergic reactions, adverse symptoms); unacceptability of treatment (drop-outs); use of health service resourcesCaries increment D(M)FS permanent - prevented fraction (n=9); caries increment d(e)fs deciduous - prevented fraction (n=1); unacceptability of treatment/drop-outs (n=6); adverse effects scarcely reported - stain score (n=1) and side effects (n=1); enamel fluorosis not reported (n=0)
Study designsRandomized or quasi-randomized controlled trials with (indicated) blind outcome assessment lasting at least 1 calendar or school year; split-mouth designs involving varnish, open/unblinded assessment, or duration <1 year excluded12 parallel-group randomized or quasi-randomized controlled trials (2 quasi-randomized; blinding 7 double-blind, 3 single-blind, 3 indicated), conducted 1966-1985, duration 2-3 years
TimingAt least 1 calendar or school year (primary analysis nearest to 3 years)2 to 3 years (analysis nearest to 3 years)

Search date: 2001-10. Databases: Cochrane Oral Health Group's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; SCISEARCH; SSCISEARCH; ISTP; BIOSIS; CINAHL; ERIC; DISSERTATION ABSTRACTS; LILACS/BBO; SIGLE; Community of Science; OLDMEDLINE; meta Register of Current Controlled Trials

Questions and results

Current version only

Fluoride mouthrinse, gel or varnish combined with fluoride toothpaste (any combined regimen) vs Fluoride toothpaste alone

Population: Children or adolescents aged 16 years or less
CD002781.PUB2 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Adverse effects (tooth staining and other side effects)
Adverse-effect data scarcely reported: a stain score in one trial and 'any side effects' in one trial without complete or useable data (stated 'no side effects observed in both groups'). No useful information on tooth…NRUngraded
Enamel fluorosis (adverse effect)
Fluorosis data have not been reported in any of the trials.0 studiesNo studies
Unacceptability of treatment (drop-outs / leaving study early)
RR 1.06 [0.93, 1.22]5 studies · 1998 participantsUngraded
Caries increment in permanent teeth: D(M)FS (prevented fraction)
Nearest to 3 years
PF 0.10 [0.02, 0.17]9 studies · 4026 participantsUngraded

Fluoride mouthrinse combined with fluoride toothpaste vs Fluoride toothpaste alone

Population: Children or adolescents aged 16 years or less
CD002781.PUB2 (current) · 2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment in permanent teeth: D(M)FS (prevented fraction)
Nearest to 3 years
PF 0.07 [0.00, 0.13]5 studies · 2738 participantsUngraded
Unacceptability of treatment (drop-outs / leaving study early)
RR 1.03 [0.84, 1.26]3 studies · 1704 participantsUngraded

Fluoride gel combined with fluoride toothpaste vs Fluoride toothpaste alone

Population: Children or adolescents aged 16 years or less
CD002781.PUB2 (current) · 1 question
OutcomeEffectEvidenceStatus / GRADE
Caries increment in permanent teeth: D(M)FS (prevented fraction)
Nearest to 3 years
PF 0.14 [-0.09, 0.38]3 studies · 1217 participantsUngraded

Fluoride varnish combined with fluoride toothpaste vs Fluoride toothpaste alone

Population: Children or adolescents aged 16 years or less
CD002781.PUB2 (current) · 3 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment in permanent teeth: D(M)FS (prevented fraction)
Nearest to 3 years
PF 0.48 [0.12, 0.84]1 study · 71 participantsUngraded
Unacceptability of treatment (drop-outs / leaving study early)
RR 1.29 [0.61, 2.71]2 studies · 294 participantsUngraded
Caries increment in deciduous teeth: d(e)fs (prevented fraction)
Nearest to 3 years
PF 0.151 study · 173 participantsUngraded

Fluoride mouthrinse combined with fluoride gel vs Fluoride mouthrinse alone

Population: Children or adolescents aged 16 years or less
CD002781.PUB2 (current) · 1 question
OutcomeEffectEvidenceStatus / GRADE
Caries increment in permanent teeth: D(M)FS (prevented fraction)
Nearest to 3 years
PF 0.02 [-0.20, 0.24]1 study · 252 participantsUngraded

Fluoride gel combined with fluoride mouthrinse vs Fluoride gel alone

Population: Children or adolescents aged 16 years or less
CD002781.PUB2 (current) · 2 questions
OutcomeEffectEvidenceStatus / GRADE
Unacceptability of treatment (drop-outs / leaving study early)
RR 1.00 [0.72, 1.40]1 study · 344 participantsUngraded
Caries increment in permanent teeth: D(M)FS (prevented fraction)
Nearest to 3 years
PF 0.23 [0.04, 0.43]2 studies · 497 participantsUngraded

Fluoride mouthrinse combined with fluoride toothpaste vs Fluoride mouthrinse alone

Population: Children or adolescents aged 16 years or less
CD002781.PUB2 (current) · 2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment in permanent teeth: D(M)FS (prevented fraction)
Nearest to 3 years
PF 0.05 [-0.05, 0.15]4 studies · 1678 participantsUngraded
Unacceptability of treatment (drop-outs / leaving study early)
RR 0.88 [0.67, 1.17]3 studies · 1697 participantsUngraded

Fluoride gel combined with fluoride toothpaste vs Fluoride gel alone

Population: Children or adolescents aged 16 years or less
CD002781.PUB2 (current) · 1 question
OutcomeEffectEvidenceStatus / GRADE
Caries increment in permanent teeth: D(M)FS (prevented fraction)
Nearest to 3 years
PF 0.10 [-0.01, 0.21]3 studies · 759 participantsUngraded

Fluoride varnish combined with fluoride toothpaste vs Fluoride varnish alone

Population: Children or adolescents aged 16 years or less
CD002781.PUB2 (current) · 2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment in deciduous teeth: d(e)fs (prevented fraction)
Nearest to 3 years
PF 0.191 study · 186 participantsUngraded
Unacceptability of treatment (drop-outs / leaving study early)
RR 0.75 [0.22, 2.59]1 study · 196 participantsUngraded

Fluoride mouthrinse, gel or varnish combined with fluoride toothpaste (combined topical fluoride regimen) vs Fluoride toothpaste alone (single topical fluoride)

Population: Children or adolescents aged 16 years or less
CD002781 · 1 question
OutcomeEffectEvidenceStatus / GRADE
Outcome NR
At least one year/school year
Protocol only (2000): no studies yet included. Planned relevant comparison: one single topical fluoride (toothpaste) versus any other topical fluoride combined with fluoride toothpaste.NRNo studies