Fluoride mouthrinses for prevention of initial caries in orthodontic patients - a systematic review and meta-analysis.
Sonesson Mikael, Twetman Svante · BMC oral health · 2025 · PubMed · doi:10.1186/s12903-025-06374-8
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 | Healthy children, adolescents and adults undergoing orthodontic multi-bracket (fixed appliance) treatment | 704 adolescents and young adults undergoing fixed orthodontic treatment across 7 RCTs (Sweden, Denmark, Netherlands, India, Iraq, Pakistan); dropout 0-32.5%; 5 studies (491 subjects) contributed to the meta-analysis (n=7 studies) |
| Intervention | Regular (daily to weekly) fluoride mouthrinses during orthodontic treatment, with a duration of at least 6 months | Fluoride mouthrinses added to twice-daily fluoride toothpaste (1100-1450 ppm): 0.05-0.32% sodium fluoride, amine fluoride, or amine/sodium fluoride mix; applied once/twice daily or twice weekly; duration 6-26 months (n=7 studies) |
| Comparison | Placebo mouthrinses, any non-fluoride mouthrinse/mouthwash, other non-fluoride comparisons, or standard care (treatment as usual) | Twice-daily fluoride toothpaste alone, placebo mouthrinse + toothpaste, or non-fluoride (chlorhexidine) mouthrinse + toothpaste (n=7 studies) |
| Outcomes | (i) Incidence of white spot lesions adjacent to brackets (clinically defined demineralization index), assessed at least 6 months after appliance onset or within 6 months after debonding; (ii) Incidence of proximal caries lesions scored from bitewing radiographs | Incidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized); pooled risk difference -0.07 (95% CI -0.14 to -0.01) from 5 studies / 491 subjects, low heterogeneity; proximal caries from bitewing radiographs assessed in 1 study (not pooled); no adverse effects reported (n=7 studies) |
| Study designs | Randomized controlled trials with parallel groups (intervention vs. control), minimum duration 6 months; peer-reviewed publications in English | All 7 included studies were randomized controlled trials: 1 single-blind, 2 double-blind, 2 triple-blind, 1 with non-blinded outcome assessment; 2 placebo-controlled (n=7) |
| Timing | Intervention duration at least 6 months; outcome assessed at least 6 months after appliance onset or within 6 months after debonding | Intervention duration 6-26 months; endpoint scored from 6 months after appliance onset to 6 weeks after debonding |
Search date: September 30, 2024. Databases: PubMed; Scopus; Web of Science; Cochrane; Google Scholar; ClinicalTrials.gov (ongoing trials)
Questions and results
Fluoride mouthrinse (0.05-0.32% sodium fluoride or amine fluoride) added to daily fluoride toothpaste vs Control: fluoride toothpaste alone, placebo mouthrinse + toothpaste, or non-fluoride (chlorhexidine) mouthrinse + toothpaste
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Incidence of initial caries around brackets, aesthetic-zone teeth only At debonding (Gorelick index) · Aesthetic zone (central and lateral incisors, canines) When only aesthetic-zone teeth (incisors and canines) were considered, two studies reported a significant reduction in initial caries incidence favoring fluoride mouthrinse (ungraded, narrative; no pooled estimate). Source: Results 'Results of individual studies' (refs [19] Enerback 2023, [21] Zahid 2024) · same question in other reviews | In two studies, a significant reduction of the incidence of initial caries around orthodontic brackets was reported in the FMR group when only teeth in the 'aesthetic zone' (central and lateral incisors, canines) were… | 2 studies | Ungraded |
Incidence of proximal (interdental) caries lesions from bitewing radiographs At debonding (~23-24 months) Only one included study assessed proximal caries incidence from bitewing radiographs; it was not included in the meta-analysis and no pooled estimate is available (ungraded). Source: Methods 'PICO' outcome (ii); Discussion (ref [18] Enerback 2022, bitewing DiFS) · same question in other reviews | In one study assessments of proximal caries incidence were made as well [18]. However, just the data on the incidence of white spot lesions was included in our meta-analysis as different endpoints for the assessments… | 1 study | Ungraded |
Adverse effects / harms (side effects) During treatment No adverse effects were reported in any of the seven included studies (ungraded). Source: Results 'Results of individual studies'; Discussion · same question in other reviews | No side- or adverse effects were reported in any of the included reports. | 7 studies · 704 participants | Ungraded |
Incidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized) End of intervention (6-26 months) to within 6 weeks after debonding Adding a fluoride mouthrinse to daily fluoride toothpaste produced a small reduction in the incidence of initial caries/white spot lesions adjacent to brackets (pooled risk difference -0.07, 95% CI -0.14 to -0.01; 5 studies, 491 subjects), but the authors judged the overall evidence inconclusive (ungraded). Source: Abstract; Results 'Meta-analysis'; Fig. 2 (forest plot; image not available, pooled risk difference read from text) · same question in other reviews | RD -0.07 [-0.14, -0.01] | 5 studies · 491 participants | Ungraded |
AMSTAR 2 appraisal
Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | Yes | yes |
| 2Protocol established before the reviewcritical | Partial Yes | No | no |
| 3Choice of study designs explained | No | No | yes |
| 4Comprehensive literature searchcritical | Partial Yes | Partial Yes | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | Partial Yes | No | no |
| 8Included studies described in detail | Partial Yes | Yes | no |
| 9Risk of bias assessed satisfactorilycritical | NRSI: N/A · RCT: Yes | NRSI: N/A · RCT: Partial Yes | no |
| 10Funding of included studies reported | No | No | yes |
| 11Appropriate meta-analysis methodscritical | RCT: Yes · NRSI: N/A | NRSI: N/A · RCT: Yes | no |
| 12Impact of risk of bias on the pooled results | No | No | yes |
| 13Risk of bias accounted for in interpretationcritical | Yes | Yes | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | No | No | yes |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Low | Critically Low | no |
Included primary studies 9
Open as a trial list| Study | Also included by | Outcomes it informs here | Trial PICO | Results |
|---|---|---|---|---|
| van der Kaaij 2015 A prospective, randomized placebo-controlled clinical trial on the effects of a fluoride rinse on white spot lesion development and… PMID:25913893 | 3 other reviews | Incidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized) | not extracted yet | not extracted yet |
| Ali 2022 Effect of nanosilver mouthwash on prevention of white spot lesions in patients undergoing fixed orthodontic treatment - a randomized… PMID:35028045 | this review only | Incidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized) | not extracted yet | not extracted yet |
| Boyd 1992 Temporal interactions in the cat visual system. I. Orientation-selective suppression in the visual cortex. PMID:1992005 | this review only | Incidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized) | not extracted yet | not extracted yet |
| Ekstrand 2023 The Efficacy of Fluoride Rinse on Caries Increment, Plaque Occurrence and Gingival Status in Children Undergoing Orthodontic Treatment. A… DOI:10.26420/jdentoraldisord.2023.1178 | this review only | Incidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized) | not extracted yet | not extracted yet |
| Enerback 2022 Effect of a mouth rinse and a high-fluoride toothpaste on caries incidence in orthodontic patients: A randomized controlled trial DOI:10.1016/j.ajodo.2022.03.011 | this review only | Incidence of proximal (interdental) caries lesions from bitewing radiographs | not extracted yet | not extracted yet |
| Enerbäck 2022 Effect of a mouth rinse and a high-fluoride toothpaste on caries incidence in orthodontic patients: A randomized controlled trial. PMID:35491328 | this review only | not stated | not extracted yet | not extracted yet |
| Enerback 2023 Effect of high-fluoride toothpaste and mouth rinse on the prevention of demineralized lesions during orthodontic treatment: a randomized… PMID:37524332 | this review only | Incidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized) | not extracted yet | not extracted yet |
| Ravikiran 2021 The Effectiveness Of Amine Fluoride Mouthwash In Preventing White Spot Lesions During Fixed Orthodontic Therapy: A Randomized Control Trial DOI:10.19070/2377-8075-21000712 | this review only | Incidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized) | not extracted yet | not extracted yet |
| Zahid 2024 DOI:10.33279/jkcd.v14i3.698 | this review only | Incidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized) | not extracted yet | not extracted yet |
Overlap with other reviews
Reviews that include the same primary studies are not independent evidence. Shared counts match studies by PMID, DOI or NCT, and otherwise by author and year (a probable match).