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
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
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Participants 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. |
| Intervention | Topical 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) |
| Comparison | Placebo/No intervention/Alternative fluoride intervention | Placebo 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) |
| Outcomes | The 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 designs | Randomised 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 |
| Timing | Not reported | Not 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
Current version onlyResin-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)
| Outcome | Effect | Evidence | Status / 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 participants | Low 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 participants | Low 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 participants | Low 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)
| Outcome | Effect | Evidence | Status / 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 participants | Low 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 participants | Low 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 participants | Low 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)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Adverse effects At debond (end of orthodontic treatment) | Additional SoF Table 2. Adverse effects: none of the trials reported this outcome. | 0 studies | No 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 participants | Very 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 studies | No 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 participants | Very 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 participants | Very 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)
| Outcome | Effect | Evidence | Status / 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 participants | Very 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 studies | No 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 participants | Very 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)
| Outcome | Effect | Evidence | Status / 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 participants | Very 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 studies | No 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 participants | Very 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)
| Outcome | Effect | Evidence | Status / 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 studies | No 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 participants | Low 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 studies | No 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)
| Outcome | Effect | Evidence | Status / 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 studies | No studies |
Adverse effects At debond (end of orthodontic treatment) | SoF 3. Adverse effects: none of the trials reported this outcome. | 0 studies | No 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 participants | Low 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)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Adverse effects At debond (end of orthodontic treatment) | SoF 4. Adverse effects: none of the trials reported this outcome. | 0 studies | No 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 studies | No 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 participants | Very low Downgraded: risk of bias, imprecision |
Fluoride varnish (Fluor Protector, 0.1% F as difluorosilane), applied every 6 weeks vs Non-fluoride placebo varnish
Population: Participants of any age undergoing orthodontic treatment with fixed braces (DWLs assessed at debond)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of participants with new demineralised white lesions (DWLs) At debond (end of orthodontic treatment) | RR 0.31 [0.21, 0.44] -442 [-506, -358] per 1000 (fewer) | 1 study · 253 participants | Moderate Downgraded: imprecision |
Amine fluoride/stannous fluoride toothpaste (Meridol 140 ppm F) twice daily + amine F/SnF2 mouthrinse (250 ppm F) at bedtime vs Sodium fluoride toothpaste (1400 ppm) twice daily + NaF mouthrinse (250 ppm F) at bedtime
Population: Participants of any age undergoing orthodontic treatment with fixed braces (DWLs assessed at debond)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
White spot lesion index (mean change from baseline) At debond (end of orthodontic treatment) | Oegaard 2006. Mean change in the white spot lesion index from baseline was greater in the sodium fluoride group, suggesting NaF was less effective than amine fluoride/stannous fluoride (reported at tooth level, no… | 1 study · 97 participants | Ungraded |
Gingival bleeding index (mean change from baseline) At debond (end of orthodontic treatment) | Oegaard 2006. Slightly larger increase in the gingival bleeding index over the duration of treatment in the sodium fluoride group (Analysis 2.3). No pooled numeric estimate reported in this version. | 1 study · 97 participants | Ungraded |
Visible plaque index (mean change from baseline) At debond (end of orthodontic treatment) | Oegaard 2006. Slightly larger increase in the visible plaque index over the duration of treatment in the sodium fluoride group (Analysis 2.2). No pooled numeric estimate reported in this version. | 1 study · 97 participants | Ungraded |
Intraoral fluoride-releasing glass bead device (13.3% fluoride glass) attached to the brace vs Daily fluoride mouthrinse (0.05% w/v NaF)
Population: Participants of any age undergoing orthodontic treatment with fixed braces (DWLs assessed at debond)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number and size of new demineralised white lesions (DWLs) At debond (end of orthodontic treatment) | Luther 2005. Results available for only 37 of 70 participants recruited (53%); 18 glass-bead breakages reported. Number and size of new DWLs determined by computerised image analysis of before/after cross-polarised… | 1 study · 37 participants | Ungraded |
Acid-phosphate-fluoride (APF) mouthrinse, daily vs No mouthrinse
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of patients with new white spots During fixed appliance treatment | Peto OR 0.41 [0.14, 1.20] | 1 study · 60 participants | Ungraded |
Sodium fluoride (0.2% NaF) mouthrinse, daily vs No mouthrinse (no fluoride supplementation)
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Enamel demineralisation (mineral loss and lesion depth on extracted premolars) 4 weeks (poorly fitting bands on premolars due for extraction) | MD -70 [-118, -22] | 1 study | Ungraded |
Stannous fluoride (0.1% SnF2) mouthrinse, daily vs Sodium monofluorophosphate (0.184% MFP) mouthrinse, daily
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of patients with new or enlarged white spots 1 year after banding | Peto OR 0.10 [0.01, 1.72] | 1 study · 22 participants | Ungraded |
Fluoride varnish (Fluor Protector, 5% difluorosilane) plus antimicrobial varnish (Cervitec, 1% chlorhexidine/1% thymol), applied alternately every 12 weeks vs Fluoride varnish (Fluor Protector) plus placebo varnish (Cervitec without chlorhexidine/thymol), alternately
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of patients with white spots During fixed appliance treatment | Peto OR 0.89 [0.52, 1.53] | 1 study | Ungraded |
Fluoridated composite resin for bonding brackets (FluorEver) vs Non-fluoridated composite resin (Aurafill)
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of patients/quadrants with white spots Mean 25 months (split-mouth) | OR 0.00 [0.00, 1.52] | 1 study · 22 participants | Ungraded |
Glass ionomer cement (incl. resin-modified GIC) for bonding orthodontic brackets vs Composite resin for bonding brackets
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of patients/quadrants with white spots Varies (4 weeks to 22 months across studies) | Three split-mouth studies, not pooled: Chung 1998a OR 0.00 (95% CI 0.00 to 1.52); Marcusson 1997 OR 0.35 (95% CI 0.13 to 0.86, significant reduction in white spots with GIC); Twetman 1997 OR 0.00 (95% CI 0.00 to 5.33).… | 3 studies | Ungraded |
Enamel mineral loss / demineralisation (severity) Short-term (extracted premolars) | Three studies, not pooled: Gorton 2003 significantly increased mineral loss with light-cured composite vs resin-modified GIC, mean difference -645 vol%.um (95% CI -915 to -375); Pascotto 2004 no difference in Knoop… | 3 studies | Ungraded |
Compomer (polyacid-modified composite, fluoride-releasing) for bonding brackets vs Composite resin for bonding brackets
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of patients/quadrants with white spots 4 weeks to 21 months (across studies) | Two controlled clinical trials, not pooled: Chung 1998b OR 0.00 (95% CI 0.00 to 2.42); Millett 2000 OR 0.22 (95% CI 0.02 to 1.07). Neither statistically significant. | 2 studies · 58 participants | Ungraded |
Compomer (light-cured, fluoride-containing) for banding molars (Band-Lok) vs Glass ionomer cement (chemical-cure, non-fluoride, Ketac-Cem) for banding molars
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of patients with new white spots Mean 20.3 months (split-mouth) | OR 0.29 [0.03, 1.50] | 1 study · 92 participants | Ungraded |
Fluoride-releasing elastomeric ligatures (elastics) vs Non-fluoridated elastomeric ligatures
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Number of patients with white spots Throughout treatment | Peto OR 0.63 [0.27, 1.50] | 1 study · 94 participants | Ungraded |
Topical fluoride (toothpaste, mouthrinse, gel or varnish; any agent NaF/SMFP/SnF2/APF/amine F) or fluoride-releasing material, any dose/frequency vs No fluoride (placebo non-fluoride product or absence of the intervention)
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | Protocol (2002): planned primary comparison - effectiveness of fluoride versus no fluoride in preventing white spot lesions during fixed orthodontic treatment. No studies included (protocol stage). | 0 studies | No studies |
One mode of fluoride delivery (e.g. mouthrinse, gel, varnish, toothpaste, or fluoride-releasing material) vs A different mode of fluoride delivery (alternative fluoride intervention)
Population: Patients of any age undergoing orthodontic treatment with fixed braces
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | Protocol (2002): planned secondary comparison - effectiveness of different modes of fluoride delivery versus each other. No studies included (protocol stage). | 0 studies | No studies |