Cochrane · intervention · CD005101

Slow‐release fluoride devices for the control of dental decay

Chong, LY, Clarkson, JE, Dobbyn‐Ross, L, et al. · Cochrane Database of Systematic Reviews · 2018 · Cochrane Library

Oral HealthDental caries4 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
9
current version
GRADE rated
4
No studies
5
Included studies
1
as reported
No studies 5 · 55.6%Ungraded 0 · 0%Very low 4 · 44.4%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 or adultsChildren (mean age 8.8 years at start, 10.9 at termination) with DMFT/dmft greater than 1 and greater than 1 million colony-forming units of mutans streptococci per mL saliva, from a deprived inner-city area (Leeds, UK) with low water fluoride (n=174; 63 analysed)
InterventionSlow-release fluoride devices (co-polymer acrylic reservoir types; slow-dissolving glass beads)Fluoride-releasing glass beads bonded to buccal surfaces of right maxillary first permanent molars (n=31)
ComparisonAlternative fluoride treatment (topical fluoride: toothpaste, mouthrinse, gel, or varnish; NaF, SMFP, SnF, APF, amine F); Placebo; No intervention or usual carePlacebo glass beads without fluoride (n=32)
OutcomesChanges in decayed, missing, and filled teeth or surfaces or both (DMFT/DMFS in permanent teeth - dmft/dmfs in primary teeth); Progression of caries lesion through enamel or into dentine; Dental pain due to decay; Retention of slow-release fluoride devices; Harms of slow-release fluoride devices; Participant satisfaction; Use of healthcare resources (cost effectiveness, time to fit, number of dental visits)Changes in DMFT/DMFS (n=63); Retention of slow-release fluoride devices (n=132)
Study designsParallel RCT (split-mouth excluded)RCT (n=1)
TimingMinimum intervention and follow-up of 1 year2 years

Search date: 2018-01. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; ClinicalTrials.gov; World Health Organization (WHO) International Clinical Trials Registry Platform

Questions and results

Current version only

Slow-release fluoride device (fluoride glass beads) vs Placebo or usual care (control)

Population: Children with high risk of dental decay
CD005101.PUB4 (current) · 8 questions
OutcomeEffectEvidenceStatus / GRADE
Increase in DMFT at 2 years compared with baseline
2 years
MD -0.72 [-1.23, -0.21]
-0.72 [-1.23, -0.21] DMFT (mean difference, scale 0 to 32)
1 study · 63 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Progression of caries lesion through enamel or into dentine
No evidence found0 studiesNo studies
Dental pain due to decay
No evidence found0 studiesNo studies
Increase in DMFS at 2 years compared with baseline
2 years
MD -1.52 [-2.68, -0.36]
-1.52 [-2.68, -0.36] DMFS (mean difference, scale 0 to 128)
1 study · 63 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Retention of slow-release fluoride devices (devices staying intact)
2 years
132 (1 study); very low; Only 63/132 (47.7%) children who were still available at 2-year follow-up had the devices intact1 study · 132 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Harms of slow-release fluoride devices
132 (1 study); very low; Study reported that no irritations or other harms were reported1 study · 132 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Use of healthcare resources (cost effectiveness, time taken to fit, number of dental visits)
The study reported no data on use of healthcare resources0 studiesNo studies
Participant satisfaction
No RCT evidence found0 studiesNo studies

Slow-release fluoride devices vs Alternative fluoride therapy (topical fluoride: toothpaste, mouthrinse, gel, or varnish)

Population: Children or adults
CD005101.PUB4 (current) · 1 question
OutcomeEffectEvidenceStatus / GRADE
Outcome NR
We found no studies comparing a slow-release fluoride device versus alternative fluoride therapy0 studiesNo studies

Slow-release fluoride device (fluoride glass beads) vs Placebo or usual care (control)

Population: Children with high risk of dental decay
CD005101.PUB3 · 8 questions
OutcomeEffectEvidenceStatus / GRADE
Increase in DMFS at 2 years compared with baseline
2 years
MD -1.52 [-2.68, -0.36]
-1.52 [-2.68, -0.36] DMFS (mean difference, scale 0 to 128)
1 study · 63 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Participant satisfaction
No RCT evidence found0 studiesNo studies
Retention of slow-release fluoride devices (devices staying intact)
2 years
132 (1 study); very low; Only 63/132 (47.7%) children who were still available at 2-year follow-up had the devices intact1 study · 132 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Harms of slow-release fluoride devices
132 (1 study); very low; Study reported that no irritations or other harms were reported1 study · 132 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Dental pain due to decay
No evidence found0 studiesNo studies
Progression of caries lesion through enamel or into dentine
No evidence found0 studiesNo studies
Use of healthcare resources (cost effectiveness, time taken to fit, number of dental visits)
The study reported no data on use of healthcare resources0 studiesNo studies
Increase in DMFT at 2 years compared with baseline
2 years
MD -0.72 [-1.23, -0.21]
-0.72 [-1.23, -0.21] DMFT (mean difference, scale 0 to 32)
1 study · 63 participantsVery low
Downgraded: risk of bias, imprecision, indirectness

Slow-release fluoride devices vs Alternative fluoride therapy (topical fluoride: toothpaste, mouthrinse, gel, or varnish)

Population: Children or adults
CD005101.PUB3 · 1 question
OutcomeEffectEvidenceStatus / GRADE
Outcome NR
We found no studies comparing slow-release fluoride device versus alternative fluoride therapy0 studiesNo studies

Slow-release fluoride device (fluoride glass beads) vs Placebo (glass beads without fluoride)

Population: Children with high risk of dental decay
CD005101.PUB2 · 6 questions
OutcomeEffectEvidenceStatus / GRADE
Increase in DMFT (caries increment) at 2 years compared with baseline
2 years
MD -0.72 [-1.23, -0.21]1 study · 63 participantsUngraded
Harms of slow-release fluoride devices
Patient harm was not measured or discussed within the trial report0 studiesNo studies
Mean salivary fluoride level
1 and 2 years
Mean salivary fluoride was significantly higher in those fitted with the fluoride-releasing beads than placebo (1 year: test 0.15 mg/L, control 0.05 mg/L; 2 years: test 0.11 mg/L, control 0.03 mg/L)1 study · 63 participantsUngraded
Participant satisfaction
No data presented on this topic0 studiesNo studies
Increase in DMFS (caries increment) at 2 years compared with baseline
2 years
MD -1.52 [-2.68, -0.36]1 study · 63 participantsUngraded
Progression of caries lesion through enamel or into dentine
No data presented on this topic0 studiesNo studies

Slow-release fluoride devices vs Alternative fluoride therapy (topical fluoride: toothpaste, mouthrinse, gel, or varnish)

Population: Children or adults
CD005101.PUB2 · 1 question
OutcomeEffectEvidenceStatus / GRADE
Outcome NR
Only one trial (device vs placebo) met inclusion; no study compared the device against an alternative fluoride therapy.0 studiesNo studies

Slow-release fluoride devices vs Placebo or no intervention

Population: Children or adults
CD005101 · 1 question
OutcomeEffectEvidenceStatus / GRADE
Outcome NR
Protocol (2005); planned comparison, no studies yet.0 studiesNo studies

Slow-release fluoride devices vs Alternative fluoride therapy (topical fluoride: toothpaste, mouthrinse, gel, or varnish)

Population: Children or adults
CD005101 · 1 question
OutcomeEffectEvidenceStatus / GRADE
Outcome NR
Protocol (2005); planned comparison, no studies yet.0 studiesNo studies