Bonacina Gabriela, Hartmann Rafael Chies, Gomes Maximiliano Schünke, Böttcher Daiana Elisabeth
School of Health and Life Sciences, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.
Health Science Institute, Universidade Feevale, Novo Hamburgo, Brazil.
BMC Oral Health. 2025 Jul 16;25(1):1182. doi: 10.1186/s12903-025-06216-7.
Pain after endodontic therapy affects from 2.5 to 60% of patients and may significantly impacts patient's quality of life and adherence to dental treatment. This blind clinical trial protocol was designed to evaluate the analgesic effect of low-level laser therapy (LLLT) and its impact on post-operative pain and on quality of life (QoL) in patients with apical periodontitis (AP) submitted to root canal treatment (RCT).
116 patients will be selected. RCT will be performed using the ProTaper Next system. Patients will be randomly allocated into 2 groups: control (naproxen prescription) and test (LLLT). Post-operative pain levels will be assessed through numeric raking scale (NRS) before intervention and at 6 h, 12 h, 24 h and 72 h after endodontic procedures. Quality of life will be assessed using the OHIP-14 before intervention, post-preparation, post-obturation and 6 months after RCT. Descriptive statistics and normality tests will be carried out, and comparison between groups will be estimated for each outcome (post-operative pain and QoL) using parametric or non-parametric tests. The significance level will be set to 5%.
This study has the potential to strengthen the evidence on postoperative pain management in Endodontics by exploring efficient and safer protocols. Additionally, it may improve the QoL of patients affected by AP.
Clinicaltrials.gov registration: RBR-5hgcgy4, registered on 31/07/2023, https://ensaiosclinicos.gov.br/rg/RBR-5hgcgy4 . Ethics Reference No: 22706919.0.0000.5336. Trial Sponsor: Pontifical Catholic University of Rio Grande do Sul. The Trial was prospectively registered.
根管治疗后的疼痛影响2.5%至60%的患者，可能会显著影响患者的生活质量和对牙科治疗的依从性。本盲法临床试验方案旨在评估低强度激光治疗（LLLT）对接受根管治疗（RCT）的根尖周炎（AP）患者的镇痛效果及其对术后疼痛和生活质量（QoL）的影响。
将选取116例患者。使用ProTaper Next系统进行根管治疗。患者将被随机分为两组：对照组（开具萘普生处方）和试验组（低强度激光治疗）。在干预前以及根管治疗术后6小时、12小时、24小时和72小时，通过数字评分量表（NRS）评估术后疼痛水平。在干预前、预备后、充填后以及根管治疗术后6个月，使用OHIP-14评估生活质量。将进行描述性统计和正态性检验，并使用参数检验或非参数检验对每组的每个结局（术后疼痛和生活质量）进行组间比较。显著性水平设定为5%。
本研究有潜力通过探索高效且更安全的方案来加强根管治疗术后疼痛管理的证据。此外，它可能改善受根尖周炎影响患者的生活质量。
Clinicaltrials.gov注册编号：RBR-5hgcgy4，于2023年7月31日注册，https://ensaiosclinicos.gov.br/rg/RBR-5hgcgy4 。伦理参考编号：22706919.0.0000.5336。试验主办方：南里奥格兰德天主教大学。该试验已进行前瞻性注册。
