Evidence map›Paper›PMID 39907699›Full record

Trial reportClinical oral investigations2025

A 12-months randomized clinical trial comparing fluoride-based remineralising protocols on post-orthodontic initial caries lesions.

Wan Nurazreena Wan Hassan, Yee Yong Tee, Khairatulamirah Md Razali, Aina Aqilah Abdul Razak, Hui Han Lim, Najwa Zakaria, Prema Sukumaran, Norhidayah Nor Zahidah Mohd Tahir, Hooi Pin Chew

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Clinical oral investigations, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04788550 (A Prospective, Open Label, Randomized Control Trial to Study the Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT04788550 naunknown statusnot on this map

A Prospective, Open Label, Randomized Control Trial to Study the Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention

TypeinterventionalSponsorUniversity of MalayaRan2021 to 2022Enrolled30ConditionsOrthodontic Appliance ComplicationArmsFluoridated toothpaste, fluoride varnish (5% sodium fluoride), CPP-ACP plus crème group
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

9 authors.

Wan Nurazreena Wan HassanDepartment of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, Universiti Malaya, 50603, Kuala Lumpur, Malaysia. wannurazreena@um.edu.my.
Yee Yong TeeFaculty of Dentistry, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.
Khairatulamirah Md RazaliFaculty of Dentistry, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.
Aina Aqilah Abdul RazakFaculty of Dentistry, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.
Hui Han LimFaculty of Dentistry, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.
Najwa ZakariaDepartment of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.
Prema SukumaranFaculty of Dentistry, Oral and Craniofacial Sciences, King's College London, London, UK.
Norhidayah Nor Zahidah Mohd TahirDepartment of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, Universiti Malaya, 50603, Kuala Lumpur, Malaysia.
Hooi Pin ChewDepartment of Restorative Sciences, Division of Operative Dentistry, University of Minnesota School of Dentistry, Malcolm Moos Health Sciences Tower, 515 Delaware St. SE, Minneapolis, MN, 55455, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare the long-term remineralization of initial caries lesion (ICL) treated with different remineralizing agents during orthodontic retention using optical coherence tomography (OCT). MATERIALS AND

methodsThis randomised clinical trial recruited 30 patients on fixed appliances with at least one ICL labially on any maxillary incisor. At debond (baseline), they were allocated to three groups, where twice daily fluoride toothpaste was given: (1) as control; (2) supplemented with daily casein phosphopeptide amorphous calcium phosphate with fluoride (CPP-ACPF); or (3) supplemented with three-monthly professional applied fluoride varnish (FV). Primary outcome was the OCT backscatter reflectance changes of the ICL, measured as integrated reflectivity (IR). Follow-ups were at three-month intervals up to 12 months. The trial was registered with Clinicaltrials.gov (NCT04788550).

resultsAnalyses included 26 participants (nine control; nine CPP-ACPF; eight FV). There were significant reduction in integrated reflectivity over time. Post hoc comparisons showed reductions were significant up to 150-micron depth at 6-months, and up to 250-micron depth at both 9- and 12-months follow-up compared to baseline. At 12-months, FV had the lowest IR values, followed by CPP-ACPF and control, but the differences between groups were not significant.

conclusionsAfter 12-months observation, use of fluoridated toothpaste alone or supplemented with either fluoride varnish or CPP-ACPF promotes enamel remineralization up to 250-micron depth. CLINICAL RELEVANCE: Daily fluoridated toothpaste with regular 3-monthly recall visits from the start of orthodontic retention is recommended for effective control of initial caries lesions. FV and CPP-ACPF supplementation can be considered but their long-term benefits remain inconclusive.

Indexed as

Cariostatic AgentsCaseinsDental CariesFluoridesFluorides, TopicalOrthodontic Appliances, FixedTooth RemineralizationAdolescentFemaleHumansMaleTomography, Optical CoherenceToothpastesTreatment OutcomeCariostatic Agentscasein phosphopeptide-amorphous calcium phosphate nanocomplexCaseinsFluoridesFluorides, TopicalToothpastesCasein phosphopeptide-amorphous calcium phosphate nanocomplexDental cariesFixed appliancesFluoridesInternational caries detection and assessment system (ICDAS)Optical coherenceTomographyTooth remineralization

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Registered trials

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.