Cochrane · intervention · CD007868

Fluoride toothpastes of different concentrations for preventing dental caries

Walsh, T, Worthington, HV, Glenny, AM, et al. · Cochrane Database of Systematic Reviews · 2019 · Cochrane Library

Oral HealthDental caries3 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
65
current version
GRADE rated
59
No studies
4
Included studies
96
as reported
No studies 4 · 6.2%Ungraded 2 · 3.1%Very low 3 · 4.6%Low 44 · 67.7%Moderate 10 · 15.4%High 2 · 3.1%

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, adolescents, or adults, irrespective of initial caries level, background fluoride exposure, receipt of dental treatment, nationality, setting, or age at recruitment; studies selecting participants on the basis of special (general or oral) health conditions were excluded.Three placebo-controlled studies (2675 randomised; 2162 evaluated) assessed adults (18 to 93 years, mature permanent dentition); eight studies (13,856 randomised; 9055 evaluated) assessed the primary dentition (1 to 4 years); 86 studies (51,304 randomised; 42,074 evaluated) assessed the immature permanent dentition of children and adolescents (5 to 18 years).
InterventionToothbrushing with a fluoride toothpaste; proposed categories: 250 ppm F; 440 to 550 ppm F; 1000 to 1250 ppm F; 1450 to 1500 ppm F; 1700 to 2200 ppm F; 2400 to 2800 ppm F; agents NaF, SMFP, SnF2, APF, AmF singly or combined; any compatible abrasive system.Placebo 0 ppm F (n=66); 250 ppm F (n=4); 440/500/550 ppm F (n=2); 1000/1055/1100/1250 ppm F (n=55); 1450/1500 ppm F (n=8); 1700/2000/2200 ppm F (n=5); 2400/2500/2800 ppm F (n=6)
ComparisonToothbrushing with a non-fluoride toothpaste, no toothpaste, or a fluoride toothpaste of a different (lower) concentration (0 ppm F category added explicitly).Placebo toothpaste (n=66); Fluoride toothpaste of different concentration (n=30)
OutcomesPrimary: caries increment - change from baseline in D(M)FS/T (permanent), change from baseline in d(e/m)fs/t (primary), change in the proportion of participants developing new caries. Secondary: adverse effects such as irritation, dental staining.Caries increment D(M)FS (n=81); Caries increment D(M)FT (n=53); Caries increment d(m)fs (n=7); Caries increment d(m)ft (n=3); Proportion developing new caries permanent dentition (n=10); Proportion developing new caries deciduous dentition (n=3); Side effects (n=16)
Study designsParallel-group randomised controlled trials (individual or cluster), follow-up at least 1 year; split-mouth designs excluded; non-randomised studies excluded.NR
TimingMinimum duration of 1 year.Minimum study duration 12 months; longest reported follow-up 7 years; analysis nearest to 3 years (closest to 36 months) follow-up.

Search date: 2018-08. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; US NIH Ongoing Trials Register ClinicalTrials.gov; WHO International Clinical Trials Registry Platform

Questions and results

Show all 3 versions

250 ppm F toothpaste vs Non-fluoride (0 ppm F) placebo toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.15 [-0.25, -0.05]3 studiesLow
Downgraded: risk of bias, inconsistency
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.11 [-0.27, 0.05]1 studyLow
Downgraded: risk of bias, inconsistency
Proportion developing new caries
Follow-up: 24 months
RR 1.07 [0.91, 1.27]
451 per 1000 vs 483 per 1000
2 studies · 684 participantsLow
Downgraded: risk of bias, imprecision

440 to 550 ppm F toothpaste vs Non-fluoride (0 ppm F) placebo toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.18 [-0.41, 0.04]2 studiesLow
Downgraded: risk of bias, inconsistency
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.12 [-0.31, 0.07]2 studiesLow
Downgraded: risk of bias, imprecision, inconsistency

1000 to 1250 ppm F toothpaste vs Non-fluoride (0 ppm F) placebo toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
4 questions
OutcomeEffectEvidenceStatus / GRADE
Proportion developing new caries
Follow-up: 12 to 60 months
RR 0.9 [0.77, 1.06]
596 per 1000 vs 536 per 1000
7 studies · 1898 participantsLow
Downgraded: risk of bias, imprecision, inconsistency
Adverse effects of toothpaste
Closest to 36 months
16 studies assessed possible side effects, principally oral (soft tissue) pathologies and tooth staining. 6 studies reported no untoward events; 6 reported greater staining in the stannous fluoride group; 1 reported no…16 studiesUngraded
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.26 [-0.31, -0.21]41 studiesHigh
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.28 [-0.32, -0.25]55 studiesHigh

1450 to 1500 ppm F toothpaste vs Non-fluoride (0 ppm F) placebo toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.39 [-0.49, -0.28]4 studiesModerate
Downgraded: risk of bias
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.36 [-0.43, -0.29]4 studiesModerate
Downgraded: risk of bias, imprecision
Proportion developing new caries
Follow-up: 36 months
RR 0.95 [0.91, 0.98]
947 per 1000 vs 900 per 1000
1 study · 945 participantsLow
Downgraded: risk of bias, imprecision

1700 to 2200 ppm F toothpaste vs Non-fluoride (0 ppm F) placebo toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.32 [-0.41, -0.22]NRLow
Downgraded: risk of bias, imprecision
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.33 [-0.56, -0.11]NRLow
Downgraded: risk of bias, imprecision

2400 to 2800 ppm F toothpaste vs Non-fluoride (0 ppm F) placebo toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.39 [-0.52, -0.25]2 studiesLow
Downgraded: risk of bias, imprecision, inconsistency
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.41 [-0.49, -0.33]3 studiesLow
Downgraded: risk of bias, inconsistency

440 to 550 ppm F toothpaste vs 250 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.08 [-0.32, 0.17]1 studyLow
Downgraded: risk of bias, imprecision, inconsistency
Caries increment, surface index D(M)FS
Closest to 36 months
SMD 0.03 [-0.17, 0.23]1 studyLow
Downgraded: risk of bias, inconsistency

1000 to 1250 ppm F toothpaste vs 250 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.15 [-0.31, 0.0]3 studiesLow
Downgraded: risk of bias, imprecision, inconsistency
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.14 [-0.24, -0.04]7 studiesLow
Downgraded: risk of bias, inconsistency

1450 to 1500 ppm F toothpaste vs 250 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.28 [-0.47, -0.09]NRLow
Downgraded: risk of bias, imprecision
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.21 [-0.33, -0.1]NRLow
Downgraded: risk of bias, imprecision

1700 to 2200 ppm F toothpaste vs 250 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.23 [-0.5, 0.05]NRLow
Downgraded: risk of bias, imprecision
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.17 [-0.3, -0.04]NRLow
Downgraded: risk of bias, imprecision

2400 to 2800 ppm F toothpaste vs 250 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.26 [-0.38, -0.14]NRLow
Downgraded: risk of bias, imprecision
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.28 [-0.48, -0.08]NRLow
Downgraded: risk of bias, imprecision

1000 to 1250 ppm F toothpaste vs 440 to 550 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.08 [-0.3, 0.15]1 studyLow
Downgraded: risk of bias, imprecision, inconsistency
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.16 [-0.35, 0.03]1 studyLow
Downgraded: risk of bias, imprecision

1450 to 1500 ppm F toothpaste vs 440 to 550 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.2 [-0.45, 0.04]NRLow
Downgraded: risk of bias, imprecision
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.24 [-0.44, -0.04]NRLow
Downgraded: risk of bias, imprecision

1700 to 2200 ppm F toothpaste vs 440 to 550 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.15 [-0.46, 0.16]NRLow
Downgraded: risk of bias, imprecision
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.2 [-0.41, 0.01]NRLow
Downgraded: risk of bias, imprecision

2400 to 2800 ppm F toothpaste vs 440 to 550 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.2 [-0.46, 0.05]NRLow
Downgraded: risk of bias, imprecision
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.29 [-0.49, -0.08]NRLow
Downgraded: risk of bias, imprecision

1450 to 1500 ppm F toothpaste vs 1000 to 1250 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.08 [-0.14, -0.01]10 studiesModerate
Downgraded: risk of bias
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.13 [-0.23, -0.02]4 studiesLow
Downgraded: risk of bias, inconsistency
Proportion developing new caries
Follow-up: 36 months
RR 1.02 [0.93, 1.11]
728 per 1000 vs 742 per 1000
2 studies · 4328 participantsLow
Downgraded: risk of bias, imprecision, inconsistency

1700 to 2200 ppm F toothpaste vs 1000 to 1250 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.07 [-0.3, 0.15]1 studyVery low
Downgraded: risk of bias, imprecision, inconsistency
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.03 [-0.12, 0.06]5 studiesLow
Downgraded: risk of bias, inconsistency

2400 to 2800 ppm F toothpaste vs 1000 to 1250 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.12 [-0.2, -0.05]6 studiesLow
Downgraded: risk of bias, inconsistency
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.12 [-0.25, 0.01]3 studiesVery low
Downgraded: risk of bias, inconsistency

1700 to 2200 ppm F toothpaste vs 1450 to 1500 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, surface index D(M)FS
Closest to 36 months
SMD 0.04 [-0.07, 0.15]NRModerate
Downgraded: risk of bias
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD 0.05 [-0.19, 0.3]NRLow
Downgraded: risk of bias, imprecision, inconsistency

2400 to 2800 ppm F toothpaste vs 1450 to 1500 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD 0.0 [-0.16, 0.17]NRLow
Downgraded: risk of bias, inconsistency
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.05 [-0.14, 0.05]2 studiesModerate
Downgraded: risk of bias

2400 to 2800 ppm F toothpaste vs 1700 to 2200 ppm F toothpaste

Population: Children and adolescents with immature permanent dentition (aged 5 to 16 years at study start)
2 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index D(M)FT
Closest to 36 months
SMD -0.05 [-0.27, 0.17]NRVery low
Downgraded: risk of bias, inconsistency
Caries increment, surface index D(M)FS
Closest to 36 months
SMD -0.09 [-0.2, 0.02]1 studyLow
Downgraded: risk of bias

1500 ppm F toothpaste vs Non-fluoride (0 ppm F) placebo toothpaste

Population: Young children with primary (deciduous) dentition (aged 1 to 6 years at study start)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index d(m)ft
12 months
No studies reported poolable d(m)ft increment; Cahen 1982 reported a df-rate of 18.25% (n=708) in the 0 ppm group vs 13.64% (n=632, 1500 ppm SMFP) and 9.37% (n=668, amine fluoride) groups.1 studyUngraded
Caries increment, surface index d(m)fs
Follow-up: 24 months
MD -1.86 [-2.51, -1.21]1 study · 998 participantsModerate
Downgraded: risk of bias
Adverse effects of toothpaste
24 months
Adverse effects of toothpaste: not estimable; 0 events reported (Fan 2008); 998 participants (1 RCT); low-certainty.1 study · 998 participantsLow
Downgraded: risk of bias, imprecision

1450 ppm F toothpaste vs 250 ppm F toothpaste

Population: Young children with primary (deciduous) dentition (aged 1 to 6 years at study start)
4 questions
OutcomeEffectEvidenceStatus / GRADE
Caries increment, tooth index d(m)ft
Follow-up: 22 months
MD -0.4 [-1.14, 0.34]1 study · 172 participantsLow
Downgraded: risk of bias, imprecision
Adverse effects of toothpaste
Adverse effects of toothpaste: no studies reported this outcome.0 studiesNo studies
Caries increment, surface index d(m)fs
Follow-up: 22 months
MD -1.2 [-2.92, 0.52]1 study · 172 participantsLow
Downgraded: risk of bias, imprecision
Proportion developing new caries
22 months
RR 0.92 [0.54, 1.57]
455 per 1000 vs 418 per 1000
1 study · 172 participantsLow
Downgraded: risk of bias, imprecision

1055 to 1100 ppm F toothpaste vs 500 to 550 ppm F toothpaste

Population: Young children with primary (deciduous) dentition (aged 1 to 6 years at study start)
4 questions
OutcomeEffectEvidenceStatus / GRADE
Adverse effects of toothpaste
12 months
Adverse effects of toothpaste: not estimable. "There were no reports on adverse effects, but some children complained about the taste of the dentifrice" (Cardoso 2014); 195 participants (1 RCT); low-certainty.1 study · 195 participantsLow
Downgraded: imprecision
Caries increment, surface index d(m)fs
Follow-up: 20 to 36 months
MD -0.05 [-0.38, 0.28]2 studies · 1958 participantsModerate
Downgraded: imprecision
Proportion developing new caries
36 months
RR 0.86 [0.74, 0.99]
484 per 1000 vs 416 per 1000
1 study · 905 participantsLow
Downgraded: risk of bias, imprecision
Caries increment, tooth index d(m)ft
Follow-up: 36 months
MD -0.27 [-0.6, 0.06]1 study · 905 participantsLow
Downgraded: risk of bias, imprecision

1450 ppm F toothpaste vs 440 ppm F toothpaste

Population: Young children with primary (deciduous) dentition (aged 1 to 6 years at study start)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Adverse effects of toothpaste
Adverse effects of toothpaste: no studies reported this outcome.0 studiesNo studies
Proportion developing new caries
60 months
RR 0.87 [0.81, 0.94]
577 per 1000 vs 502 per 1000
1 study · 2362 participantsModerate
Downgraded: imprecision
Caries increment, tooth index d(m)ft
Follow-up: 60 months
MD -0.34 [-0.59, -0.09]1 study · 2362 participantsModerate
Downgraded: imprecision

1000 or 1100 ppm F toothpaste vs Non-fluoride (0 ppm F) placebo toothpaste

Population: Adults with mature permanent dentition (aged 18 to 93 years at study start)
4 questions
OutcomeEffectEvidenceStatus / GRADE
Proportion developing new caries
Proportion of adults developing new caries: no studies reported this outcome.0 studiesNo studies
Caries increment, tooth index DMFT
24 months
MD -0.46 [-0.93, 0.01]1 study · 247 participantsLow
Downgraded: risk of bias, imprecision
Adverse effects of toothpaste
Adverse effects of toothpaste: no studies reported this outcome.0 studiesNo studies
Caries increment, surface index DMFS
12 to 24 months
MD -0.53 [-1.02, -0.04]3 studies · 2162 participantsModerate
Downgraded: risk of bias