Exploring the Potential of Minimally Invasive Sagittal Split Ramus Osteotomy to Transform Patient Outcomes: A Randomized, Double-Blind, Controlled Split Mouth Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Bleeding
研究概览
简要总结
This randomized, double-blind, controlled, split-mouth clinical trial investigates the effects of two different surgical approaches - the conventional technique and a minimally invasive technique - during bilateral sagittal split ramus osteotomy (SSRO) for mandibular deformity correction. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University.
Each patient will receive both surgical techniques, randomly assigned to either side of the mandible. All procedures will be performed under general anesthesia by the same surgeon. Intraoperative outcomes including bleeding volume and operative time will be recorded. Postoperative evaluations will be conducted on day 1, weeks 1, 2, and 4, and at 3 months to assess pain and swelling.
This study aims to determine whether the minimally invasive SSRO technique can improve surgical efficiency and reduce postoperative morbidity compared to the conventional approach, without compromising treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent sagittal split ramus osteotomy for mandibular dentofacial deformity
- •Patients classified as ASA I or II
- •Patients over 18 years of age
排除标准
- •Patients with uncontrolled diabetes
- •Patients with metabolic bone diseases (e.g., hyperparathyroidism, Paget's disease)
- •Patients with syndromic conditions (e.g., Pierre Robin syndrome, Treacher Collins syndrome)
- •Patients who had previously undergone mandibular surgery due to trauma, tumors, or cysts and had sequelae involving the lower jaw
结局指标
主要结局
Bleeding
时间窗: Intraoperative period (from skin incision to final suture placement)
Bleeding volume will be measured in milliliters from the initial skin incision to the final suture placement, using separate calibrated aspirators for the left and right sides.
Operative Time
时间窗: Intraoperative period (from skin incision to final suture placement)
Operative time will be measured in minutes, separately for the right and left sides, from the initial skin incision to the final suture placement, using a chronometer.
次要结局
- Postoperative Edema(Postoperative days 1, 7, 14, and 30)
- Postoperative Pain(Postoperative hours 1, 2, 4, 6, 8, 10, and 12)
研究者
İbrahim Mert Erkan
resident
TC Erciyes University