Hamdy Ismail Hend, Obeid Maram Farouk, ElSaid Hassanein Ehab
Faculty of Dentistry, Ain Shams University, Organization of African Unity Street, Cairo, Egypt, 11766.
Lasers Med Sci. 2025 Jan 23;40(1):31. doi: 10.1007/s10103-024-04242-5.
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).
随着光生物调节在牙科领域的不断发展，这项前瞻性双臂临床试验的目的是评估在下颌磨牙原发性根管治疗后，应用或不应用二极管激光于软组织的情况下，慢性根尖周骨病变的影像学变化。样本被随机分为激光组和模拟激光（ML）组。由两名观察者将术前CBCT图像与术后12个月的CBCT图像进行比较，以测量骨病变体积的变化。计算kappa系数以评估观察者内一致性。数据以中位数、均值和标准差（SD）值表示。对于参数数据（年龄），使用 Student's t检验。定性数据（性别）以频率和百分比表示，然后通过卡方检验进行分析。采用Wilcoxon符号秩检验比较治疗前后的CBCT测量值。显著性水平设定为P≤0.05。本研究收集的数据表明，激光组和ML组根尖周病变的中位数体积之间分别无统计学显著差异（P值 = 0.564，效应量 = 0.237）和（P值 = 0.452，效应量 = 0.310），而每组治疗后根尖周病变体积均有统计学显著减小（P值 < 0.001）。无论是否应用激光，传统牙髓治疗后根尖周骨病变的大小均显著减小。在艾因夏姆斯大学牙科学院伦理委员会批准后，该研究方案于（2020年3月17日）在www.clinicaltrials.gov数据库注册为NCT04311905。
