Non-Cochrane · intervention · PM40604756

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

Oral HealthDental cariesOrthodonticsAMSTAR 2: Low / Critically Low (extractors disagree)
Full textEvery question was extracted from the full text, figures and supplements by two independent LLM extractors, disagreements adjudicated. Rows cite where in the review the value comes from.
Questions
4
current version
GRADE rated
0
No studies
0
Included studies
9
linked below
No studies 0 · 0%Ungraded 4 · 100%Very low 0 · 0%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)
PopulationHealthy children, adolescents and adults undergoing orthodontic multi-bracket (fixed appliance) treatment704 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)
InterventionRegular (daily to weekly) fluoride mouthrinses during orthodontic treatment, with a duration of at least 6 monthsFluoride 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)
ComparisonPlacebo 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 radiographsIncidence 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 designsRandomized controlled trials with parallel groups (intervention vs. control), minimum duration 6 months; peer-reviewed publications in EnglishAll 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)
TimingIntervention duration at least 6 months; outcome assessed at least 6 months after appliance onset or within 6 months after debondingIntervention 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

Population: Children, adolescents and adults undergoing fixed (multi-bracket) orthodontic treatment
4 questions
OutcomeEffectEvidenceStatus / 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 studiesUngraded
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 studyUngraded
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 participantsUngraded
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 participantsUngraded

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.

ItemExtractor AExtractor BAgree
1Research question includes PICO componentsYesYesyes
2Protocol established before the reviewcriticalPartial YesNono
3Choice of study designs explainedNoNoyes
4Comprehensive literature searchcriticalPartial YesPartial Yesyes
5Study selection in duplicateYesYesyes
6Data extraction in duplicateYesYesyes
7List of excluded studies with reasonscriticalPartial YesNono
8Included studies described in detailPartial YesYesno
9Risk of bias assessed satisfactorilycriticalNRSI: N/A · RCT: YesNRSI: N/A · RCT: Partial Yesno
10Funding of included studies reportedNoNoyes
11Appropriate meta-analysis methodscriticalRCT: Yes · NRSI: N/ANRSI: N/A · RCT: Yesno
12Impact of risk of bias on the pooled resultsNoNoyes
13Risk of bias accounted for in interpretationcriticalYesYesyes
14Heterogeneity explainedYesYesyes
15Publication bias investigatedcriticalNoNoyes
16Conflicts of interest reportedYesYesyes
OverallLowCritically Lowno

Included primary studies 9

Open as a trial list
StudyAlso included byOutcomes it informs hereTrial PICOResults
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 reviewsIncidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized)not extracted yetnot 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 onlyIncidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized)not extracted yetnot extracted yet
Boyd 1992
Temporal interactions in the cat visual system. I. Orientation-selective suppression in the visual cortex.
PMID:1992005
this review onlyIncidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized)not extracted yetnot 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 onlyIncidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized)not extracted yetnot 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 onlyIncidence of proximal (interdental) caries lesions from bitewing radiographsnot extracted yetnot 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 onlynot statednot extracted yetnot 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 onlyIncidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized)not extracted yetnot 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 onlyIncidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized)not extracted yetnot extracted yet
Zahid 2024
DOI:10.33279/jkcd.v14i3.698
this review onlyIncidence of initial enamel caries / white spot lesions adjacent to bracket base (subject level, dichotomized)not extracted yetnot 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).