BMJ open · 2025
Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Cirisola Rolf Wilhem Consolandich, Moya Luis Eduardo Pascuali, Olazabal María Victoria García, Wagmann Daniela Anat Amzallag, Suarez Guendalina Palermo, Wince Carolina, Bruno María Laura Hermida, Salaberry Daniel Rodriguez, Sobral Ana Paula Taboada, Longo Priscila Larcher, Motta Lara Jansiski, Bussadori Sandra Kalil, Duran Cinthya Cosme Gutierrez, Fernandes Kristianne Porta Santos, Mesquita-Ferrari Raquel Agnelli, Horliana Anna Carolina Ratto Tempestini
Аннотация
INTRODUCTION: Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.
METHODS AND ANALYSIS: A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p<0.05.
ETHICS AND DISSEMINATION: The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.
TRIAL REGISTRATION NUMBER: NCT05935306.
METHODS AND ANALYSIS: A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p<0.05.
ETHICS AND DISSEMINATION: The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.
TRIAL REGISTRATION NUMBER: NCT05935306.