Assessment of Robot-Assisted Mandibular Contouring Surgery in Comparison With Traditional Surgery: A Prospective, Single-Center, Randomized Controlled Trial.

BACKGROUND: Few clinical studies on robot-assisted surgery (RAS) for mandibular contouring have been reported. OBJECTIVES: The aim of this study was to follow the long-term effectiveness and safety of RAS for craniofacial bone surgery. METHODS: This small-sample, early-phase, prospective, randomized controlled study included patients diagnosed with mandibular deformity requiring mandibular contouring surgery. Patients of both genders aged 18 to 30 years without complicated craniofacial repair defects were enrolled and randomly assigned in a 1:1 ratio by a permuted-block randomized assignments list generated by the study statistician. The primary outcomes were the positioning accuracy and accuracy of the osteotomy plane angle 1 week after surgery. Surgical auxiliary measurement index, patient satisfaction scale, surgical pain scale, perioperative period, and complications at 1 week, 1 month, and 6 months after surgery were also analyzed. RESULTS: One patient was lost to follow-up, resulting in a total of 14 patients in the traditional surgery group and 15 in the robot-assisted group (mean [standard deviation] age, 22.65 [3.60] years). Among the primary outcomes, there was a significant difference in the positioning accuracy (2.91 mm vs 1.65 mm; P < 0.01) and angle accuracy (13.26º vs 4.85º; P < 0.01) between the 2 groups. Secondary outcomes did not significantly differ. CONCLUSIONS: Compared to traditional surgery, robot-assisted mandibular contouring surgery showed improved precision in bone shaving, as well as higher safety.

Efficacy of navigation system-assisted distraction osteogenesis for hemifacial microsomia based on artificial intelligence for 3 to 18 years old: study protocol for a randomized controlled single-blind trial.

BACKGROUND: Mandibular distraction osteogenesis (MDO) is a major part of the treatment for hemifacial microsomia patients. Due to the narrow surgical field of the intraoral approach, osteotomy accuracy is highly dependent on the surgeons' experience. Electromagnetic (EM) tracking systems can achieve satisfying accuracy to provide helpful real-time surgical navigation. Our research team developed an EM navigation system based on artificial intelligence, which has been justified in improving the accuracy of osteotomy in the MDO in animal experiments. This study aims to clarify the effect of the EM navigation system in improving the MDO accuracy for hemifacial microsomia patients. METHODS: This study is designed as a single-centered and randomized controlled trial. Altogether, 22 hemifacial microsomia patients are randomly assigned to the experiment and control groups. All patients receive three-dimensional CT scans and preoperative surgical plans. The EM navigation system will be set up for those in the experiment group, and the control group will undergo traditional surgery. The primary outcome is the surgical precision by comparing the osteotomy position of pre- and postoperative CT scan images through the Geomagic Control software. The secondary outcomes include mandibular symmetry (occlusal plane deviation angle, mandibular ramus height, and body length), pain scale, and complications. Other indications, such as the adverse events of the system and the satisfactory score from patients and their families, will be recorded. DISCUSSION: This small sample randomized controlled trial intends to explore the application of an EM navigation system in MDO for patients, which has been adopted in other surgeries such as orthognathic procedures. Because of the delicate structures of children and the narrow surgical view, accurate osteotomy and protection of nearby tissue from injury are essential for successful treatment. The EM navigation system based on artificial intelligence adopted in this trial is hypothesized to provide precise real-time navigation for surgeons and optimally improve patient outcomes, including function and aesthetic results. The results of this trial will extend the application of new navigation technology in pediatric plastic surgery. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2200061565. Registered on 29 June 2022.

Applying artificial intelligence algorithm in the design of a guide plate for mandibular angle ostectomy.

PURPOSE: Surgical guide plates can improve the accuracy of surgery, although their design process is complex and time-consuming. This study aimed to use artificial intelligence (AI) to design standardized mandibular angle ostectomy guide plates and reduce clinician workload. METHODS: An intelligence algorithm was designed and trained to design guide plates, with a safety-ensuring penalty factor added. A single-center retrospective cohort study was conducted to test the algorithm among patients who had visited our hospital between 2020 and 2021 for mandibular angle ostectomy. We included patients diagnosed with mandibular angle hypertrophy and excluded those combined with other facial malformations. The guide plate design method acted as the primary predictor, which was AI algorithm vs. experienced residents. Moreover, the symmetry of plate-guided ostectomy was chosen as the primary outcome. The safety, shape, location, effectiveness, and design duration of the guide plate were also recorded. The independent samples t-test and Pearson's chi-squared test were used and P-values < 0.05 were considered significant. RESULTS: Fifty patients (7 men, 43 women; 27 ± 4 years) were included. The two groups differed significantly in terms of safety (7.02 vs. 5.25, P < 0.05) and design duration (24.98 vs. 1685.08, P ＜ 0.05). The ostectomy symmetry and shape, location, and effectiveness of the guide plates did not differ significantly between the two groups. CONCLUSIONS: The intelligent algorithm can improve safety and save time for guide plate design, ensuring other quality of the guide plates. It has good potential applicability in accurate mandibular angle ostectomy.

The clinical outcomes of new hyaluronan nasal dressing: a prospective, randomized, controlled study.

BACKGROUND: Poor postoperative wound healing after endoscopic sinus surgery (ESS) remains a significant problem. This study evaluates the efficacy and safety of a new absorbable hyaluronan hydrogel. METHODS: A prospective, randomized, controlled trial was conducted. Fifty-five patients with bilateral ESS were recruited and randomized to receive absorbable hyaluronan hydrogel in one side as treated and the opposite side without absorbable hyaluronan hydrogel as control. Clinical outcome measures were assessed at postoperative 1, 2, 4, 8, and 12 weeks. RESULTS: Fifty-four patients completed the study. Overall, absorbable hyaluronan hydrogel significantly promotes the reepithelization process and reduces the presence of obstructing synechia, nonobstructing synechia, edema, crust, and mild mucopurulent drainage (all p ≤ 0.0002). At all postoperative follow-up visits, the promotion in reepithelization is statistically significant at 2, 4, and 8 weeks, and the reductions in the presence of nonobstructing synechia, edema, crust, and mild mucopurulent drainage are all statistically significant except for the presence of crust at 12 weeks and mild mucopurulent drainage at 1 and 12 weeks. Although the presence of obstructing synechia at each follow-up visit between groups does not reach statistical significance, the incidence ranges from 5.56 to 12.96% in the control group and from 0 to 3.70% in the treated group. No adverse event related to treatment was observed. CONCLUSION: In this clinical study, data analyses suggest that this new absorbable hyaluronan hydrogel, as nasal dressing/packing after ESS is safe and promotes the postoperative reepithelization process and reduces the presence of synechia, edema, crust, and mild mucopurulent drainage.