Caries inhibition with CO(2)-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial

INTRODUCTION: White spot lesions associated with orthodontic treatment are a common problem. Recent studies reported increased resistance to acid demineralization of enamel after sub-ablative CO(2)-laser irradiation in a combination with fluoride application. The aim of the study is to assess the efficacy of CO(2)-laser in combination with a fluoride varnish in the prevention, severity, and extent of white spot lesions during orthodontic treatment with fixed appliances. METHODS AND ANALYSIS: 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 CO(2)-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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04903275. Registered on June 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06117-y.