The efficiency of single-session photobiomodulation on healing of periapical bone lesions using CBCT: a randomized clinical trial.

Abstract

As photobiomodulation is growing in the dental field the aim of this prospective, two-arm clinical trial was to assess the radiographic changes for chronic periapical bone lesions related to mandibular molars after primary root canal therapy with or without applying Diode laser on soft tissue. The samples were randomly divided into a Laser group and a mock laser (ML) group. Preoperative CBCT images were compared 12 months later with postoperative CBCT to gauge the changes in the volume of the bony lesion by two observers. The kappa coefficient was calculated to assess the intra-observer agreement. Data were presented as median, mean, and standard deviation (SD) values. For parametric data (age), a Student's t-test was used. Qualitative data (Gender) was presented as frequencies and percentages and then analyzed by Chi-square test. The Wilcoxon signed-rank test was used to compare CBCT measurements pre- and post-treatment. The significance level was set at P ≤ 0.05. The collected data in this study showed that there was no statistically significant difference between median volumes of the periapical lesion in the Laser and ML groups (P-value = 0.564, Effect size = 0.237) and (P-value = 0.452, Effect size = 0.310), respectively while, there was a statistically significant decrease in the volume of periapical lesion post-treatment within each group (P-value < 0.001). The size of the periapical bony lesion decreased significantly after conventional endodontic treatment whether Laser was applied or not. The study protocol was enrolled as NCT04311905 at www.clinicaltrials.gov database on (17/03/2020) after the approval of the Ethics Committee, Faculty of Dentistry, Ain Shams University (FDASURecID091703).