Cochrane · intervention · CD007592

Fluoride supplements (tablets, drops, lozenges or chewing gums) for preventing dental caries in children

Tubert‐Jeannin, S, Auclair, C, Amsallem, E, et al. · Cochrane Database of Systematic Reviews · 2011 · 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
13
current version
GRADE rated
8
No studies
1
Included studies
11
as reported
No studies 1 · 7.7%Ungraded 4 · 30.8%Very low 3 · 23.1%Low 1 · 7.7%Moderate 4 · 30.8%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 level of dental caries, background exposure to fluorides, dental treatment level, nationality, setting where intervention is received or time when it started)7196 children (aged 2 to 12 years) in 11 included trials; recruited from school settings in seven studies and from selected dental clinics in four; two trials in high caries-risk children and one in children with cleft lip and/or palate; all in communities without water fluoridation
InterventionPostnatal ingestion of fluoride supplements in the form of tablets (chewable or not), drops, lozenges or chewing gums: with or without vitamins; using any fluoride agent at any concentration, amount, frequency or technique of application (sucked or not, chewed or not); with or without topical fluoride based measures or non-fluoride based measuresFluoride supplements: tablets (n=7); drops (n=1); lozenges (n=3); agents sodium fluoride NaF (n=10) and acidulated phosphate fluoride APF (n=3); doses 0.25 to 1 mg F
ComparisonNo fluoride supplements: no treatment; placebo supplement (with or without vitamins); topical fluoride based measures (fluoride rinse, topical fluoride application, fluoride varnish or fluoride toothpaste); other preventive measures (chlorhexidine, xylitol, sealants, oral hygiene interventions, etc.)Placebo supplements (n=3); No treatment (n=2); Fluoride rinse (n=3); Fluoride varnish (n=2); Fluoridated toothpaste (n=1); Xylitol lozenges (n=1)
OutcomesPrimary: change in caries increment measured by difference in decayed, missing and filled teeth (dmft/DMFT) or surfaces (dmfs/DMFS) between baseline and final evaluation, for permanent and deciduous dentition. Secondary: differences in final caries experience (final dmft/DMFT or dmfs/DMFS); other measures such as proportion of children developing new caries or changes in caries-free subjects. Adverse effects: dental fluorosis (assessed with a specific index) and any other possible negative effectsCaries increment on permanent tooth surfaces D(M)FS (n=10); Caries increment on deciduous tooth surfaces dmfs (n=4); Caries increment in permanent teeth D(M)FT (n=9); Caries increment in deciduous teeth dmft (n=4); Fluorosis (n=1); Plaque and gingivitis (n=1)
Study designsRandomised (or quasi-randomised) controlled clinical trials (RCTs), randomisation at the level of the child or of a group (cluster); studies with an intervention or follow-up period of less than 2 years excludedRandomised or quasi-randomised controlled trials (11 trials; conducted 1968 to 2008)
TimingIntervention or follow-up period of at least 2 yearsFollow-ups of 24 to 36 months most common (all 11 trials); three trials also reported longer follow-ups (48, 55, 60, 72 and 96 months)

Search date: 2011-10. Databases: The Cochrane Oral Health Group's Trials Register; The Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; EMBASE via Ovid; LILACS via BIREME Virtual Health Library; PanAmerican via BIREME Virtual Health Library; WHOLIS via BIREME Virtual Health Library; MedCarib via BIREME…

Questions and results

Show all 2 versions

Fluoride supplements (tablets, drops, lozenges or chewing gums) vs No fluoride supplement (placebo or no treatment)

Population: Children and adolescents (aged 16 years or less at baseline)
7 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment on permanent tooth surfaces (D(M)FS)
24-36 months
PF 0.24 [0.16, 0.33]
Mean caries increment across control (no-treatment) groups ranged from 2.64 to 12.29 surfaces vs Mean caries increment…
3 studies · 1240 participantsModerate
Downgraded: risk of bias, indirectness
Caries increment in permanent teeth (D(M)FT)
24-36 months
PF 0.29 [0.19, 0.39]
Mean caries increment across control groups ranged from 0.52 to 5.64 teeth vs Mean caries increment in intervention…
3 studies · 1208 participantsModerate
Downgraded: risk of bias, indirectness
Caries increment on deciduous tooth surfaces (dmfs)
24-36 months
PF 0.73 [0.46, 0.99]
Mean caries increment in the control group was 8.35 surfaces vs Mean caries increment in intervention groups ranged…
1 study · 115 participantsVery low
Downgraded: risk of bias, imprecision
Caries increment on permanent tooth surfaces (DMFS)
55 months
PF 0.25 [0.12, 0.38]1 studyUngraded
Fluorosis (adverse effect; % of children with fluorotic teeth, questionable to severe)
55 months
% of children with fluorotic teeth (questionable to severe), follow-up 55 months. Assumed risk 32/212 = 15%; corresponding risk 40/202 = 20% (APF once a day) and 43/197 = 22% (APF twice a day). Relative effect: Not…
32/212 = 15% (placebo control) vs 40/202 = 20% (APF once a day); 43/197 = 22% (APF twice a day)
1 study · 611 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Caries increment on permanent tooth surfaces (DMFS)
72 months
PF 0.28 [0.16, 0.41]1 studyUngraded
Caries increment in deciduous teeth (dmft)
24-36 months
PF 0.46 [0.08, 0.83]
Mean caries increment across control groups ranged from 1.02 to 4.24 teeth vs Mean caries increment in intervention…
2 studies · 696 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency

Fluoride supplements (tablets, drops, lozenges or chewing gums) vs Topical fluoride (fluoride rinse, varnish or toothpaste)

Population: Children and adolescents (aged 16 years or less at baseline)
5 questions
OutcomeEffectEvidenceStatus / GRADE
Fluorosis (adverse effect; % of children with fluorotic teeth)
Summary of findings 2 lists fluorosis (% of children with fluorotic teeth) as 'See comment / Not estimable / Not estimated'; no included study reported fluorosis for the fluoride supplements versus topical fluoride…NRNo studies
Plaque and gingivitis scores
24 months
One study (Holm 1975): no difference between groups (fluoride supplements versus fluoride rinses) for mean plaque and gingivitis scores after 2 years. No summary estimate reported.1 studyUngraded
Caries increment on permanent tooth surfaces (DMFS)
96 months
PF 0.21 [0.04, 0.38]1 studyUngraded
Caries increment on permanent tooth surfaces (D(MF)S)
24-36 months
PF -0.10 [-0.25, 0.05]
Mean caries increment across control (topical fluoride) groups ranged from 0.9 to 5.4 surfaces vs Mean caries…
5 studies · 2047 participantsModerate
Downgraded: risk of bias
Caries increment on deciduous tooth surfaces (d(m)fs)
24-36 months
PF 0.13 [-0.07, 0.33]
Mean caries increment across control (topical fluoride) groups ranged from 1.7 to 2.5 surfaces vs Mean caries…
2 studies · 1051 participantsModerate
Downgraded: risk of bias

Fluoride supplements (tablets, drops, lozenges or chewing gums) vs Other preventive measures (xylitol lozenges)

Population: Children and adolescents (aged 16 years or less at baseline)
1 question
OutcomeEffectEvidenceStatus / GRADE
Caries increment on permanent tooth surfaces (DMFS, approximal surfaces)
24-36 months
PF 0.00 [-0.59, 0.59]
Mean caries increment in the control group was 2.7 surfaces vs Mean caries increment in the intervention group was 2.7…
1 study · 115 participantsLow
Downgraded: risk of bias, imprecision, indirectness