biostudies-literatureBelcheva ABMedical University of Plovdiv: medicinski universitet-plovdiv208https://www.ebi.ac.uk/biostudies/studies/S-EPMC8917669biostudies-literatureUnknown23(1)<h4>Introduction</h4>White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative CO₂-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of CO₂-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances.<h4>Methods and analysis</h4>This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12-18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to CO₂-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student's t test for paired samples and proportional odds logistic regression model, p<0.05.<h4>Ethics and dissemination</h4>The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University-Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations.<h4>Trial registration</h4>ClinicalTrials.gov NCT04903275 . Registered on June 2021.TrialsCaries inhibition with CO₂-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial.PMC8917669n/aBelcheva ABShindova MPfalseCaries inhibition with CO₂-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial.<h4>Introduction</h4>White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative CO₂-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of CO₂-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances.<h4>Methods and analysis</h4>This is a protocol for a randomized, split-mouth controlled, clinical trial. The participants will be children aged 12-18 years at high caries risk, requiring fixed orthodontic treatment. The vestibular surfaces of maxillary anterior teeth of eligible patients will be exposed to CO₂-laser irradiation in combination with fluoride therapy and fluoride therapy alone followed by bonding of orthodontic brackets. The patients will be recalled 6 and 12 months post-irradiation. Outcome measures will be visual examination with International Caries Detection and Assessment System criteria and SoproLife fluorescence. Data will be analyzed by Student's t test for paired samples and proportional odds logistic regression model, p<0.05.<h4>Ethics and dissemination</h4>The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (Reference number P-605/27.03.2020, Protocol of approval No. 2/01.04.2021) and registered on a publicly accessible database. This research received institutional funding from the Medical University-Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations.<h4>Trial registration</h4>ClinicalTrials.gov NCT04903275 . Registered on June 2021.2022-01-01T00:00:00Z2022 Mar2026-05-30T16:49:51.185Z2025-02-19T05:04:51.356ZS-EPMC89176693527922010.1186/s13063-022-06117-y