Trial design, subjects, eligibility criteria, and settings
inflammation, orthodontic
INFLAMMATION, DENTAL PLAQUE
The null hypothesis is that there is no difference between the blue-light LED toothbrush and manual toothbrush in reducing dental plaque and gingival inflammation in orthodontic patients with fixed appliances. To test this hypothesis, a randomized controlled trial (RCT) with a single-blind two-treatment crossover design was performed. The Consolidated Standards of Reporting Trials (CONSORT) checklist, a guideline for conducting and reporting this trial, is presented in Fig. 
The CONSORT flow diagram: a crossover randomized controlled trial

Twenty-four patients being treated with fixed orthodontic appliances at the post-graduate orthodontic clinic at the Faculty of Dentistry, Chulalongkorn University from October 2021 to June 2022 were recruited. Written informed consent was obtained from the patients before the experimental period. Patients with at least 20 fully erupted permanent teeth, excluding third molars, were being treated with fully bonded fixed appliances, from at least one first molar to the other first molar in the same arch, for more than 1 month, and their remaining irregularity index was less than 1 mm [