Abstract
BACKGROUND: The objective of this randomized clinical trial was to evaluate Low-Level Laser Therapy (LLLT) effectiveness in spontaneous and chewing pain reduction following initial orthodontic archwire placement. METHODS: 26 patients (mean age 20.07 ± 3.13 years) with maxillary Little's Irregularity Index (LII) of 7 mm or more that indicates first maxillary premolars extraction and no medications intake were eligible for this trial. Patients were randomly assigned with 1:1 ratio using simple randomization technique to receive either LLL or placebo treatment. Blinding was applicable for patients only. In the laser group, patients received a single LLL dose (wavelength 830 nm, energy 2 J/point) in four points (2 buccal, 2 palatal) for each maxillary anterior tooth root. Patients in the placebo group had the same laser application procedure without emitting the laser beam. Patients were asked to score spontaneous and chewing pain intensity by filling out a questionnaire with a 100-mm Visual Analogue Scale (VAS) after 1, 6, 24, 48, and 72 h of treatment application. Independent t-test was used to compare the mean pain scores between the laser and placebo groups for both spontaneous and chewing pain at each studied time point. RESULTS: No dropout occurred so the results of the 26 patients were statistically analyzed. Despite some clinical differences observed between the two groups, no statistical significance was found for each studied time point (p > 0.05) for both spontaneous and chewing pain except after 72 h for chewing pain with a VAS score of (18.84 ± 13.44) mm for the laser group compared to (38.15 ± 27.06) mm for the placebo group. CONCLUSIONS: LLLT, with the suggested parameters, is not effective in pain reduction following initial orthodontic archwire placement. TRIAL REGISTRATION: Name of the registry: Clinicaltrials.gov Trial registration number: NCT02568436. Date of registration: 26 September 2015 'Retrospectively registered'.