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Randomized Controlled Trial
. 2025 Feb 5;29(2):111.
doi: 10.1007/s00784-025-06172-0.

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

Wan Nurazreena Wan Hassan  1 , Yee Yong Tee  2 , Khairatulamirah Md Razali  2 , Aina Aqilah Abdul Razak  2 , Hui Han Lim  2 , Najwa Zakaria  3 , Prema Sukumaran  4 , Norhidayah Nor Zahidah Mohd Tahir  3 , Hooi Pin Chew  5
Affiliations
Randomized Controlled Trial

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

Wan Nurazreena Wan Hassan et al. Clin Oral Investig. .

Abstract

Objectives: To 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 methods: This 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).

Results: Analyses 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.

Conclusions: After 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.

Keywords: Casein phosphopeptide-amorphous calcium phosphate nanocomplex; Dental caries; Fixed appliances; Fluorides; International caries detection and assessment system (ICDAS); Optical coherence; Tomography; Tooth remineralization.

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Conflict of interest statement

Declarations. Ethics approval: This study was performed in line with the principles of the Declaration of Helsinki. Ethics approval was obtained from the Medical Ethics Research Committee, Faculty of Dentistry, Universiti Malaya [Ref: DF CD2027/0134 (P); October 15, 2020]. The research was registered with ClinicalTrials.gov (Ref: NCT04788550). Consent to participate: Informed consent was obtained from all individual participants included in the study. Competing interests: The authors declare no competing interests.

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References

    1. Gomez J (2015) Detection and diagnosis of the early caries lesion. BMC Oral Health 15(1):S3. https://doi.org/10.1186/1472-6831-15-S1-S3 - DOI - PubMed - PMC
    1. Şen S, Erber R, Deurer N, Orhan G, Lux CJ, Zingler S (2020) Demineralization detection in orthodontics using an ophthalmic optical coherence tomography device equipped with a multicolor fluorescence module. Clin Oral Invest 24(8):2579–2590. https://doi.org/10.1007/s00784-019-03116-3 - DOI
    1. Machiulskiene V, Campus G, Carvalho JC, Dige I, Ekstrand KR, Jablonski-Momeni A, Maltz M, Manton DJ, Martignon A, Martinez-Mier EA, Pitts NB, Schulte AG, Splieth CH, Tenuta LMA, Zandona AF, Nyvad B (2020) Terminology of dental caries and dental caries management: consensus report of a workshop organized by ORCA and cariology research group of IADR. Caries Res 54(1):7–14. https://doi.org/10.1159/000503309 - DOI - PubMed
    1. Abou Neel EA, Aljabo A, Strange A, Ibrahim S, Coathup M, Young AM et al (2016) Demineralization–remineralization dynamics in teeth and bone. Int J Nanomedicine 11:4743. https://doi.org/10.2147/IJN.S107624 - DOI - PubMed - PMC
    1. Grohe B, Mittler S (2021) Advanced non-fluoride approaches to dental enamel remineralization: the next level in enamel repair management. Biomater Biosyst 4:100029. https://doi.org/10.1016/j.bbiosy.2021.100029 - DOI - PubMed - PMC

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