Cochrane · intervention · CD003067

Pit and fissure sealants versus fluoride varnishes for preventing dental decay in the permanent teeth of children and adolescents

Kashbour, W, Gupta, P, Worthington, HV, et al. · Cochrane Database of Systematic Reviews · 2020 · Cochrane Library

Oral HealthDental caries5 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
17
current version
GRADE rated
5
No studies
3
Included studies
11
as reported
No studies 3 · 17.6%Ungraded 9 · 52.9%Very low 5 · 29.4%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 and adolescents from the general population, younger than 20 years of age at the start of the studyChildren aged 5 to 10 years at start; 3374 randomised, 2553 evaluated; 11 studies (9 contributing to analyses)
InterventionPit and fissure sealants of all materials (except first-generation resin-based sealants); Pit and fissure sealants plus fluoride varnishResin-based fissure sealant (n=7: Bravo, Chestnutt, Kalnina, Liu, Raadal, Salem, Tang); Glass ionomer fissure sealant (n=1: Ji); Resin-modified glass ionomer fissure sealant (n=2: Florio, Tagliaferro); Resin-based fissure sealant plus fluoride varnish (n=1: Splieth)
ComparisonFluoride varnishFluoride varnish (n=11)
OutcomesOccurrence of new dentinal carious lesions on treated occlusal surfaces within 12 months (yes/no); Changes from baseline in DMF figures at surface, tooth and whole-mouth levels; Progression of dentinal carious lesions into dentine; Time taken to apply; Number of visits for repair; Safety (presence or absence of adverse events)Occurrence of new dentinal carious lesions (n=7); DMFS/DMFT increment (Tang, n=1); Progression of caries into dentine (Florio, n=1); DMF increment high/low caries risk (Tagliaferro, n=1); Changes in DMF at whole-mouth level (Splieth, n=1); Number of visits (Bravo, n=1); Adverse events reported (n=5); Brief economic commentary (4 economic evaluations)
Study designsRCT with at least 12 months of follow-up (parallel-group and split-mouth)Parallel-group RCT (n=6); Split-mouth RCT (n=2); Cluster-randomised RCT (n=3: Bravo, Salem, Tang)
TimingAt least 12 monthsFollow-up: 12 months (n=1); 2 years (n=6); 3 years (n=2); 4 years (n=1); 9 years (n=1)

Search date: 19 March 2020. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov; World Health Organization International Clinical Trials Registry Platform

Questions and results

Current version only

Resin-based fissure sealant vs Fluoride varnish

Population: Children and adolescents from the general population, younger than 20 years of age at the start of the study
CD003067.PUB5 (current) · 8 questions
OutcomeEffectEvidenceStatus / GRADE
Time taken to apply pit and fissure sealant or fluoride varnish
None of the studies measured time taken to apply pit and fissure sealant or fluoride varnish (resin sealant versus fluoride varnish comparison).0 studiesNo studies
Safety of sealants and fluoride varnishes (adverse events)
Five studies (Bravo 2005; Chestnutt 2017; Kalnina 2016; Liu 2012; Tagliaferro 2011) considered adverse events; participants detected and reported no adverse events.5 studiesUngraded
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
9 years
RR 0.48 [0.29, 0.79]1 study · 75 participantsVery low
Downgraded: risk of bias, imprecision
Number of visits to the dentist for repair of sealant or fluoride varnish application
MD 5.02 [4.55, 5.94]1 study · 75 participantsUngraded
Change in DMFT (decayed, missing and filled permanent teeth) increment
2 years
MD -0.08 [-0.14, -0.02]1 study · 542 participantsUngraded
Change in DMFS (decayed, missing and filled permanent surfaces) increment
2 years
MD -0.09 [-0.15, -0.03]1 study · 542 participantsUngraded
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
4 years
RR 0.42 [0.21, 0.84]1 study · 75 participantsVery low
Downgraded: risk of bias, imprecision
Dentine caries in permanent molars (yes/no)
2-3 years
OR 0.67 [0.37, 1.19]
-63 [-129, 32] per 1000
4 studies · 1683 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency

Resin-based fissure sealant plus fluoride varnish vs Fluoride varnish alone

Population: Children and adolescents from the general population, younger than 20 years of age at the start of the study
CD003067.PUB5 (current) · 5 questions
OutcomeEffectEvidenceStatus / GRADE
Progression of dentinal carious lesions into enamel or dentine
The study (Splieth 2001) did not report progression of dentinal carious lesions into enamel or dentine.0 studiesNo studies
Number of visits to the dentist for repair of sealant or fluoride varnish application
The study (Splieth 2001) did not measure the number of visits to the dentist for repair of sealant or fluoride varnish application.0 studiesNo studies
Time taken to apply pit and fissure sealant or fluoride varnish
Splieth 2001: total time for sealing and resealing two teeth averaged 29 minutes over 2 years (about 17 minutes initial sealants); each fluoride varnish application under 3 minutes (total 9 minutes).1 studyUngraded
Changes from baseline in decayed, missing and filled (DMF) figures at whole-mouth level
2 years
Splieth 2001: whole-mouth mean DMFS increased from 0.2 to 0.6 after 1 year and to 1.1 after 2 years; most caries on occlusal surfaces of first permanent molars (50.9%).1 study · 92 participantsUngraded
Dentine caries in permanent molars (yes/no)
2 years
OR 0.30 [0.17, 0.55]
-144 [-176, -87] per 1000
1 study · 92 participantsVery low
Downgraded: risk of bias, imprecision, indirectness

Resin-modified glass ionomer fissure sealant vs Fluoride varnish

Population: Children and adolescents from the general population, younger than 20 years of age at the start of the study
CD003067.PUB5 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Progression of dentinal carious lesions into enamel or dentine
1 year
OR 0.18 [0.01, 4.27]1 study · 21 participantsUngraded
Change in DMF increment on occlusal surfaces of first permanent molars
24 months · low caries risk
MD 0.07 [-0.03, 0.17]1 studyUngraded
Change in DMF increment on occlusal surfaces of first permanent molars
24 months · high caries risk
MD 0.23 [0.02, 0.44]1 studyUngraded
Dentine caries in permanent molars (yes/no)
1, 2 and 3 years
SoF2: No evidence of a difference between interventions in caries after 1, 2 and 3 years; 995 (3 studies); Very low. Studies were clinically different so not combined in meta-analyses; 1 study (Tagliaferro 2011)…3 studies · 995 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency

Resin-based fissure sealant (visible-light-polymerized) vs Fluoride varnish

Population: Children and adolescents from the general population, younger than 20 years of age at the start of the study
CD003067.PUB4 · 5 questions
OutcomeEffectEvidenceStatus / GRADE
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
9 years
RR 0.48 [0.29, 0.79]1 study · 75 participantsUngraded
Dentine caries in permanent molars (yes/no)
2 years
OR 0.69 [0.50, 0.94]
132 per 1000 vs 95 per 1000
2 studies · 358 participantsLow
Downgraded: indirectness
Safety of sealants and fluoride varnishes (adverse events)
Three studies (Bravo 2005; Liu 2012; Tagliaferro 2011) considered adverse events; participants detected and reported no adverse events. The other five studies did not mention adverse events.3 studiesUngraded
Number of visits to the dentist for repair of sealant or fluoride varnish application
Bravo 2005: average treatment visits per child 2.2 (SD 1.1) for resin sealant group vs 7.3 (SD 1.0) for varnish group.1 study · 75 participantsUngraded
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
4 years
RR 0.42 [0.21, 0.84]1 study · 75 participantsUngraded

Resin-based fissure sealant plus fluoride varnish vs Fluoride varnish alone

Population: Children and adolescents from the general population, younger than 20 years of age at the start of the study
CD003067.PUB4 · 3 questions
OutcomeEffectEvidenceStatus / GRADE
Time taken to apply pit and fissure sealant or fluoride varnish
Splieth 2001: total time for sealing and resealing two teeth averaged 29 minutes over 2 years (about 17 minutes initial sealants); each fluoride varnish application under 3 minutes (total 9 minutes).1 studyUngraded
Changes in decayed, missing and filled (DMF) figures at whole-mouth level
2 years
Splieth 2001: whole-mouth mean DMFS increased from 0.2 to 0.6 after 1 year and to 1.1 after 2 years; most caries on occlusal surfaces of first permanent molars (50.9%).1 study · 92 participantsUngraded
Dentine caries in permanent molars (yes/no)
2 years
OR 0.30 [0.17, 0.55]
223 per 1000 vs 79 per 1000
1 study · 92 participantsLow
Downgraded: risk of bias, imprecision, indirectness

Resin-modified glass ionomer fissure sealant plus oral health education vs Fluoride varnish plus oral health education

Population: Children and adolescents from the general population, younger than 20 years of age at the start of the study
CD003067.PUB4 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Change in DMF increment on occlusal surfaces of first permanent molars
24 months · low caries risk
Tagliaferro 2011: for low-caries-risk groups, no statistically significant differences among treatments after 24 months.1 studyUngraded
Change in DMF increment on occlusal surfaces of first permanent molars
24 months · high caries risk
Tagliaferro 2011: after 24 months, high-risk sealant group (HRS) mean DMF increment 0.06 (SD 0.25) vs high-risk varnish group (HRV) 0.29 (SD 0.68); similar caries increment reported.1 studyUngraded
Dentine caries in permanent molars (yes/no)
1, 2 and 3 years
SoF2: No difference in caries after 1, 2 and 3 years. 3 trials (1 study 21 evaluated children at 1 year [Florio 2001, RMGI, OR 0.18, 95% CI 0.01 to 4.27]; 2 studies 581 evaluated at 2 years [Ji 2007, Tagliaferro 2011];…3 studiesVery low
Downgraded: risk of bias, imprecision, inconsistency
Progression of caries lesion into enamel or dentine
1 year
Florio 2001 (RMGI vs fluoride varnish at 1 year) included only enamel caries lesions and reported arrestment of enamel caries lesions or progression into dentine with both interventions (Analysis 2.1).1 study · 21 participantsUngraded

Resin-based fissure sealant (visible-light-polymerized) vs Fluoride varnish

Population: Children and adolescents under 20 years of age
CD003067.PUB3 · 5 questions
OutcomeEffectEvidenceStatus / GRADE
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
4 years
RR 0.42 [0.21, 0.84]1 study · 75 participantsUngraded
Safety of sealants and fluoride varnishes (adverse events)
None of the studies reported possible harmful effects of sealants or fluoride varnishes.0 studiesNo studies
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
23 months
RR 0.74 [0.58, 0.95]1 study · 121 participantsUngraded
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
9 years
RR 0.48 [0.29, 0.79]1 study · 75 participantsUngraded
Number of visits to the dentist for repair of sealant or fluoride varnish application
Bravo 2005: average treatment visits per child 2.2 (SD 1.1) for the sealant group vs 7.3 (SD 1.0) for the varnish group.1 study · 75 participantsUngraded

Resin-based fissure sealant plus fluoride varnish vs Fluoride varnish alone

Population: Children and adolescents under 20 years of age
CD003067.PUB3 · 3 questions
OutcomeEffectEvidenceStatus / GRADE
Time taken to apply pit and fissure sealant or fluoride varnish
Splieth 2001: total time for sealing/resealing two teeth averaged 29 minutes over 2 years; fluoride varnish under 3 minutes per application (total 9 minutes).1 studyUngraded
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
24 months
RR 0.36 [0.21, 0.61]1 study · 98 participantsUngraded
Changes in decayed, missing and filled (DMF) figures at whole-mouth level
2 years
Splieth 2001: mean whole-mouth DMFS increased from 0.2 to 0.6 after 1 year and to 1.1 after 2 years.1 study · 98 participantsUngraded

Resin-modified glass ionomer fissure sealant vs Fluoride varnish

Population: Children and adolescents under 20 years of age
CD003067.PUB3 · 2 questions
OutcomeEffectEvidenceStatus / GRADE
Progression of caries lesion into enamel or dentine
12 months
Only one study (Florio 2001) reported arrestment of enamel caries lesion or its progression into dentine with both interventions.1 study · 23 participantsUngraded
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
12 months
RR 0.22 [0.01, 4.06]1 study · 23 participantsUngraded

Resin-based fissure sealant vs Fluoride varnish

Population: Children and adolescents under 20 years of age
CD003067.PUB2 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Safety of sealants and fluoride varnishes (adverse events)
None of the studies reported possible harmful effects of sealants or fluoride varnishes.0 studiesNo studies
Number of visits to the dentist for repair of sealant or fluoride varnish application
Bravo 2005: average treatment visits per child during the active phase 2.2 (SD 1.1) for the sealant group vs 7.3 (SD 1.0) for the varnish group.1 study · 75 participantsUngraded
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
9 years
RR 0.48 [0.29, 0.79]1 study · 75 participantsUngraded
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
23 months
RR 0.74 [0.58, 0.95]1 study · 121 participantsUngraded

Resin-based fissure sealant plus fluoride varnish vs Fluoride varnish alone

Population: Children and adolescents under 20 years of age
CD003067.PUB2 · 3 questions
OutcomeEffectEvidenceStatus / GRADE
Time taken to apply pit and fissure sealant or fluoride varnish
Splieth 2001: total time for sealing and resealing two teeth averaged 29 minutes over 2 years (about 17 minutes for initial sealants); mean treatment time for each fluoride varnish application under 3 minutes (total 9…1 studyUngraded
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
24 months
RR 0.36 [0.21, 0.61]1 study · 98 participantsUngraded
Changes in decayed, missing and filled (DMF) figures at whole-mouth level
2 years
Splieth 2001: mean DMFS score of the whole mouth increased from 0.2 to 0.6 after 1 year and to 1.1 after 2 years; most caries still occurred on occlusal surfaces of first permanent molars (50.9%).1 study · 98 participantsUngraded

Resin-modified glass ionomer fissure sealant vs Fluoride varnish

Population: Children and adolescents under 20 years of age
CD003067.PUB2 · 2 questions
OutcomeEffectEvidenceStatus / GRADE
Progression of caries lesion into enamel or dentine
12 months
None of the studies compared the progression of caries lesion into enamel or dentine between the pit and fissure sealant group and the fluoride varnish group.0 studiesNo studies
Incidence of dentinal carious lesion on treated occlusal surfaces of molars or premolars (yes/no)
12 months
Florio 2001 (resin-modified glass ionomer) failed to find a statistically significant difference at 12 months; sample sizes and event numbers small (0/29 sealed vs 2/36 fluoride-varnished child-surfaces).1 study · 23 participantsUngraded

Pit and fissure sealants of all generations vs Fluoride varnish

Population: Children and adolescents under 20 years of age
CD003067 · 1 question
OutcomeEffectEvidenceStatus / GRADE
Outcome NR
Protocol only (no studies): planned comparison of pit and fissure sealants versus fluoride varnish for preventing dental decay.0 studiesNo studies