Cochrane · intervention · CD003809

Fluorides for preventing early tooth decay (demineralised lesions) during fixed brace treatment

Benson, PE, Parkin, N, Dyer, F, et al. · Cochrane Database of Systematic Reviews · 2019 · Cochrane Library

Oral HealthDental cariesOrthodontics4 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
26
current version
GRADE rated
16
No studies
10
Included studies
10
as reported
No studies 10 · 38.5%Ungraded 0 · 0%Very low 8 · 30.8%Low 8 · 30.8%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)
PopulationParticipants of any age who had orthodontic treatment with fixed braces in situations where DLs were assessed on teeth remaining in the mouth at the end of orthodontic treatment (at debonding, immediately after the active fixed brace is removed). We excluded studies that evaluated demineralisation of extracted teeth (ex vivo) or that were undertaken over short periods of time i.e. less than the whole time the fixed brace was in the mouth.Seven of the included studies were conducted in Europe, involving Sweden, the UK, the UK and Republic of Ireland, and the Netherlands. One study was undertaken in Germany and Israel and two in China. Participant age ranged from 10 years at the start of treatment to 60 years. All participants in the included trials were recruited at the start of their orthodontic treatment with fixed appliances and were followed until their fixed appliances were removed.
InterventionTopical fluoride in the form of toothpaste, mouthrinse, gel, varnish, foam or dietary sources at any dose, frequency, duration or method of administration, and with any of the following active agents/ingredients: NaF (sodium fluoride), SMFP (sodium monofluorophosphate), SnF (stannous fluoride), APF (acidulated phosphate fluoride) and amine F (amine fluoride) applied either by a professional in the dental surgery or office, or used by the patient at home. Materials containing fluoride that is potentially released during treatment, including fluoride‐releasing composite resin‐bonding materials, compomers, glass ionomer cements and resin‐modified glass ionomers for bonding or banding, slow‐release fluoride beads/devices and fluoride‐releasing elastomeric ligatures.Fluoride varnish (n=3); Fluoride foam (n=1); Fluoride gel (n=1); Fluoride toothpaste (n=1); Fluoride mouthrinse (n=1); Fluoride toothpaste/mouthrinse combinations (n=2); Fluoride‐releasing materials (n=2)
ComparisonPlacebo/No intervention/Alternative fluoride interventionPlacebo varnish (n=2); Placebo foam (n=1); Placebo gel (n=1); Standard fluoride toothpaste (n=1); Placebo mouthrinse (n=1); Sodium fluoride toothpaste/mouthrinse combination (n=1); Light‐cured composite resin (n=1); Fluoride mouthrinse (n=1)
OutcomesThe primary outcome was the difference in the proportion of participants in the experimental and comparison groups with new DLs on the day the fixed appliance was removed. This could be assessed directly from the participant (clinically) or preferably from start and finish photographs or fluorescent images of the teeth immediately after the active fixed brace was removed. Secondary outcomes: Differences in the severity of the new DLs, as assessed by number, size and colour between experimental and control groups at the end of orthodontic treatment. Any quantitative assessment of enamel mineral loss, such as fluorescent light techniques or microradiography, used with in situ caries models at the end of treatment. Any participant‐assessed outcomes, such as perception of DLs and oral health‐related quality of life data. Adverse effects.Number of participants with new DLs (n=7); Number of participants with more severe DLs (n=2); White spot index (n=1); Visible plaque index (n=1); Gingival bleeding index (n=1); Number of participants with adverse effects (n=1)
Study designsRandomised controlled trials (RCTs) in which fluoride was delivered by any method to prevent the development of new enamel demineralised lesions (DLs) during fixed orthodontic treatment. As topical fluorides are distributed throughout the mouth by saliva, the use of a within‐person or split‐mouth study design to evaluate these interventions is inappropriate, due to potential carry‐across effects and any study using this design was excluded. Studies involving multiple arms would be examined and only comparisons between two fluoride interventions or fluoride versus no fluoride interventions would be included in the pairwise analysis.NR
TimingNot reportedNot reported

Search date: 1 February 2019. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid

Questions and results

Show all 4 versions

Resin-modified glass ionomer cement for bonding orthodontic brackets vs Light-cured composite resin for bonding brackets

Population: Orthodontic patients of any age with fixed braces (new DLs assessed at debond)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Number of participants with new demineralised lesions (DLs)
At debond; follow-up 17.6 months
RR 1.17 [0.69, 1.99]
3.80 [-6.90, 22.10] % (percentage points)
1 study · 173 participantsLow
Downgraded: risk of bias, imprecision
Adverse effects
At debond; follow-up 17.6 months
SoF 5. Adverse effects: no evidence that either intervention had adverse effects. 173 participants (1 RCT, Benson 2019); certainty LOW.1 study · 173 participantsLow
Downgraded: risk of bias, imprecision
Number of participants with more severe DLs of aesthetic concern
At debond; follow-up 17.6 months
RR 1.18 [0.45, 3.12]
1.40 [-4.40, 16.90] % (percentage points)
1 study · 173 participantsLow
Downgraded: risk of bias, imprecision

Professionally-applied fluoride varnish (7700 or 10,000 ppm F), every 6 weeks vs Non-fluoride (placebo) varnish

Population: Orthodontic patients of any age with fixed braces (new DLs assessed at debond)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Number of participants with new demineralised lesions (DLs)
At debond; follow-up 1.7 years
RR 0.52 [0.14, 1.93]
-13.80 [-24.80, 26.80] % (percentage points)
2 studies · 405 participantsLow
Downgraded: imprecision, indirectness
Number of participants with more severe DLs (score 3 or 4 versus 1 or 2)
At debond; follow-up 1.7 years
RR 0.46 [0.22, 0.95]
-14.10 [-20.30, -1.30] % (percentage points)
1 study · 148 participantsLow
Downgraded: imprecision, indirectness
Adverse effects
At debond; follow-up 1.7 years
SoF 1. Adverse effects: no evidence that the intervention had adverse effects; only 1 participant with an adverse event and unclear if directly related to the intervention. 148 participants (1 RCT, Sonesson 2019);…1 study · 148 participantsLow
Downgraded: imprecision, indirectness

1400/250 ppm F (amine F/SnF2) toothpaste + mouthrinse, daily vs 1400/250 ppm F (NaF) toothpaste + mouthrinse, daily

Population: Orthodontic patients of any age with fixed braces (new DLs assessed at debond)
5 questions
OutcomeEffectEvidenceStatus / GRADE
Adverse effects
At debond (end of orthodontic treatment)
Additional SoF Table 2. Adverse effects: none of the trials reported this outcome.0 studiesNo studies
White spot lesion index (mean change from baseline)
At debond; follow-up 1.5 years
MD -0.05 [-0.10, 0]1 study · 97 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Number of participants with more severe DLs (severity of DLs)
At debond (end of orthodontic treatment)
Additional SoF Table 2. Number of participants with more severe DLs: none of the trials reported this outcome.0 studiesNo studies
Gingival bleeding index (mean change from baseline)
At debond; follow-up 1.5 years
MD -0.07 [-0.15, 0.01]1 study · 97 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
Visible plaque index (mean change from baseline)
At debond; follow-up 1.5 years
MD -0.09 [-0.18, 0]1 study · 97 participantsVery low
Downgraded: risk of bias, imprecision, indirectness

Intraoral fluoride-releasing glass bead device attached to the brace vs 250 ppm F (daily) fluoride mouthrinse

Population: Orthodontic patients of any age with fixed braces (new DLs assessed at debond)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Adverse effects
At debond; follow-up 19 months
Additional SoF Table 3. Adverse effects: current design of the fluoride glass bead inadequate; high attrition partly due to bead breakages ('an improved method of attachment is needed'). 37 participants (1 RCT, Luther…1 study · 37 participantsVery low
Downgraded: risk of bias, imprecision
Number of participants with more severe DLs (severity of DLs)
At debond (end of orthodontic treatment)
Additional SoF Table 3. Number of participants with more severe DLs: none of the trials reported this outcome.0 studiesNo studies
Number of participants with new demineralised lesions (DLs)
At debond; follow-up 19 months
RR 1.51 [0.73, 3.10]
18.80 [-9.90, 77.40] % (percentage points)
1 study · 37 participantsVery low
Downgraded: risk of bias, imprecision

12,500 ppm F (NaF/olaflur/dectaflur) amine fluoride gel, professionally applied every 3 months plus home use vs 0 ppm F placebo gel

Population: Orthodontic patients of any age with fixed braces (new DLs assessed at debond)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Number of participants with new demineralised lesions (DLs)
At debond; mean follow-up 16.6 months
RR 0.99 [0.76, 1.27]
-0.40 [-10.30, 11.60] % (percentage points)
1 study · 312 participantsVery low
Downgraded: risk of bias, imprecision, publication bias
Number of participants with more severe DLs (severity of DLs)
At debond (end of orthodontic treatment)
Additional SoF Table 1. Number of participants with more severe DLs: none of the trials reported this outcome.0 studiesNo studies
Adverse effects
At debond; mean follow-up 16.6 months
Additional SoF Table 1. Adverse effects: with placebo gel 0.60%; with fluoride gel 0.00% (0 to 0); difference 0.60% fewer (0.60 fewer to 0.60 fewer); relative effect not estimable; 312 participants (1 RCT); certainty…
-0.60 [-0.60, -0.60] % (percentage points)
1 study · 312 participantsVery low
Downgraded: risk of bias, imprecision, publication bias

Professionally-applied 12,300 ppm F APF foam, every 2 months vs 0 ppm F placebo foam

Population: Orthodontic patients of any age with fixed braces (new DLs assessed at debond)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Number of participants with more severe DLs (severity of DLs)
At debond (end of orthodontic treatment)
SoF 2. Number of participants with more severe DLs: none of the trials reported this outcome.0 studiesNo studies
Number of participants with new demineralised lesions (DLs)
At debond; mean follow-up 18 months
RR 0.26 [0.11, 0.57]
-36.20 [-43.60, -21] % (percentage points)
1 study · 95 participantsLow
Downgraded: risk of bias, imprecision
Adverse effects
At debond (end of orthodontic treatment)
SoF 2. Adverse effects: none of the trials reported this outcome.0 studiesNo studies

Patient-used 5000 ppm F toothpaste, daily vs 1450 ppm F (conventional) toothpaste, daily

Population: Orthodontic patients of any age with fixed braces (new DLs assessed at debond)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Number of participants with more severe DLs (severity of DLs)
At debond (end of orthodontic treatment)
SoF 3. Number of participants with more severe DLs: none of the trials reported this outcome.0 studiesNo studies
Adverse effects
At debond (end of orthodontic treatment)
SoF 3. Adverse effects: none of the trials reported this outcome.0 studiesNo studies
Number of participants with new demineralised lesions (DLs)
At debond; follow-up 1.8 years
RR 0.68 [0.46, 1.00]
-8.50 [-14.30, 0] % (percentage points)
1 study · 380 participantsLow
Downgraded: risk of bias, imprecision

Patient-used 250 ppm F mouthrinse (100 ppm amine F/150 ppm NaF), daily vs 0 ppm F placebo mouthrinse, daily

Population: Orthodontic patients of any age with fixed braces (new DLs assessed at debond)
3 questions
OutcomeEffectEvidenceStatus / GRADE
Adverse effects
At debond (end of orthodontic treatment)
SoF 4. Adverse effects: none of the trials reported this outcome.0 studiesNo studies
Number of participants with more severe DLs (severity of DLs)
At debond (end of orthodontic treatment)
SoF 4. Number of participants with more severe DLs: none of the trials reported this outcome.0 studiesNo studies
Number of participants with new demineralised lesions (DLs)
At debond; follow-up 24.5 months (assessed with QLF)
RR 0.65 [0.37, 1.17]
-16.30 [-29.40, 7.90] % (percentage points)
1 study · 81 participantsVery low
Downgraded: risk of bias, imprecision