Evidence map›Paper›PMID 41714816›Full record

Trial reportOrthodontics & craniofacial research2026

Comparison of the Effectiveness of Fluoride Varnish and Fluoride-Releasing Adhesives in Preventing and Managing White Spot Lesions During Fixed Orthodontic Treatment, and Evaluation of Patient-Reported Outcomes: A Randomised Controlled Trial 1 Year After Debonding.

Arisha Izhar, Panchali Batra, Sanjay Miglani, Nitika Monga, Sakshi Katyal

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Orthodontics & craniofacial research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Arisha IzharDepartment of Orthodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India.
Panchali BatraDepartment of Orthodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India.
Sanjay MiglaniDepartment of Conservative Dentistry & Endodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India.
Nitika MongaDivision of Development Research, ICMR Headquarters, New Delhi, India.
Sakshi KatyalDepartment of Orthodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India.

Funding

Indian Council of Medical Research 3/1/2(14)/Oral/2019-NCD-II
6 · The paper itself

Abstract

backgroundWhite spot lesions (WSL) may appear on teeth during fixed orthodontic treatment. Professionally administered topical fluorides play a key role in preventing such lesions. However, the evidence for their long-term efficacy and patient-reported outcomes is limited.

objectiveThe primary objective was to evaluate the efficacy of topical fluorides (varnish vs. adhesive) in reducing the incidence of white spot lesions (WSLs) during and after 1 year of fixed orthodontic treatment. The secondary objectives were patient-related outcomes, including perception of WSLs and adverse effects of the two agents. TRIAL

designThree-arm, double-blind, placebo-controlled, single-centre, single-operator randomised controlled trial.

methodsOne hundred and fifty patients in the age group 14-20 years (mean age 17.98 ± 4.97) seeking fixed orthodontic treatment were randomly allocated into three groups. Group I -fluoride varnish (Fluor-Protector), Group II- fluoride adhesive (Reliance Light bond TM), and Group III- Placebo. Patients were screened for WSLs at T0 (pre-treatment), T1 (at debond), and T2 (one-year follow-up) using three methods: (i) laser-induced fluorescence device (DIAGNOdent Pen), (ii) visual, and (iii) photographic methods. A 5-point scale was used at T1 and T2 to evaluate the patient's perception.

resultsFluoride varnish showed the least number of new WSLs and the least progression of WSLs (Group I-8.95%; Group II-20.82%; and Group III-20%). Most of the lesions developed in the anterior teeth. There was more than a 50% spontaneous reduction (remineralization) in WSLs, 1 year post debond (T1 vs. T2), signifying the tendency of remineralization irrespective of the fluoride prophylaxis given during treatment. Most patients (61.8%) did not notice the lesions at debonding, and the scores increased to 95.1% of patients not noticing these lesions.

conclusion95% of patients do not notice WSLs after 1 year of debonding. Fluoride varnish was significantly more effective in preventing WSLs and could be considered during fixed orthodontic treatment, especially in patients with poor oral hygiene. There was no difference in remineralization in the three groups in the 1 year follow-up period.

trial registrationThe protocol was published in the clinical trial registry prior to the trial commencement (Clinical Trials Registry, Trial CTRI/2021/11/037918, URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Mzc4OTA=&Enc=&userName= [Registered on: 10/11/2021] - Trial Registered Prospectively).

Indexed as

Cariostatic AgentsDental CariesDental CementsDental DebondingFluorides, TopicalOrthodontic Appliances, FixedPatient Reported Outcome MeasuresAdolescentComposite ResinsDouble-Blind MethodDrug CombinationsFemaleFluoride TreatmentHumansMalePolyurethanesCariostatic AgentsComposite ResinsDental CementsDrug CombinationsFluorides, TopicalFluor ProtectorPolyurethanesReliance Light BondResin CementsSilanesdemineralizationfixed orthodonticsfluoride adhesivefluoride varnishlong‐term follow‐uppatient‐reported outcomesrandomised controlled trialwhite spot lesion

Identifiers

PMID41714816
PMCPMC13485204

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.