[Evaluation of the efficacy and safety of multi-wavelength semiconductor laser for oral soft tissue incision and gingivectomy: a prospective, multicenter, randomized, parallel-controlled, non-inferiority clinical trial].

Objective: To evaluate the clinical efficacy and safety of the multi-wavelength semiconductor laser therapeutic instrument in oral soft tissue incision and gingivectomy. Methods: A total of 156 patients who received mandibular impacted wisdom tooth extraction combined with oral soft tissue incision or gingivectomy at the Stomatological Hospital of Zhejiang University School of Medicine, Zhejiang Hospital and Wenzhou Central Hospital between June 2023 and March 2024 were enrolled and divided into experimental group (n=78) and control group (n=78) by stratified block randomization method. During the operation, the experimental group used the multi-wavelength semiconductor laser therapeutic instrument to complete soft tissue incision and gingivectomy in the surgical area, while the control group used the single-wavelength semiconductor laser therapeutic instrument for the corresponding procedures. Follow-up assessments were conducted one week and one month postoperatively for both groups of patients. Primary outcomes were the excellent and good rate of intraoperative hemostasis and wound healing at one week postoperatively, which were analyzed by non-inferiority test. Secondary outcomes included laser cutting efficiency, convenience of disinfection, operational convenience, operational safety and stability, which were assessed using the Wilcoxon rank-sum test, χ2 test or Fisher's exact probability method. Safety indicator was the incidence of adverse events, which was analyzed using Fisher's exact probability method. Results: Primary efficacy evaluation: the excellent and good rate of intraoperative hemostasis [100.0% (78/78) vs. 100.0% (78/78)] and wound healing [100.0% (78/78) vs 98.7% (77/78)] in the experimental group were both non-inferior to those in the control group. Secondary efficacy evaluation: the laser cutting efficiency in experimental group [(0.08±0.07) mm/s] was significantly higher than that in control group [(0.06±0.04) mm/s] (Z=-2.87, P=0.004). There were no significant differences in disinfection convenience, operational convenience, safety, and stability between the two groups (all P>0.05). Regarding safety evaluation, no adverse events occurred in the experimental group, while 2 cases (2.6%) of mild or moderate adverse events and 1 case (1.3%) of serious adverse events occurred in the control group, with no significant difference (P>0.05). Conclusions: The efficacy and safety of the multi-wavelength semiconductor laser therapeutic instrument are non-inferior to the control products, meeting the standards for clinical validation.