Comparison of Postoperative Pain and Swelling in Flap Versus Flapless Technique for Surgical Removal of Partially Impacted Mandibular Third Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- postoperative pain score
研究概览
简要总结
This randomized controlled trial evaluates postoperative pain and facial swelling following surgical removal of partially impacted mandibular third molars using flap versus flapless techniques. The aim is to determine which method results in lower postoperative morbidity on the second postoperative day.
详细描述
Impacted mandibular third molars frequently require surgical extraction, often involving mucoperiosteal flap elevation and bone removal. These steps may contribute to postoperative complications such as pain, swelling, and trismus. Minimally invasive alternatives, including flapless extraction, aim to reduce surgical trauma.
This study compares postoperative pain and swelling after flap versus flapless techniques in patients with partially impacted mesioangular mandibular third molars. Pain will be assessed using a 10-point Visual Analogue Scale (VAS), and swelling will be measured using standardized anthropometric facial measurements. A total of 160 participants will be randomized into two equal groups. All procedures will be performed by a single surgeon to reduce bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years
- •Either gender
- •Partially impacted mesioangular mandibular third molar confirmed clinically and radiographically
- •Second episode of pericoronitis
- •Swelling present on the affected side
- •No bone recession or periodontal disease on radiograph
排除标准
- •HIV or HBV infection
- •Diabetes or other metabolic disorders
- •Bleeding disorders including von Willebrand disease, thalassemia, hemophilia, thrombocytosis, or thrombocytopenia
- •Periapical infection or acute pericoronitis at time of surgery
- •Severe trismus
- •Immunocompromised status
结局指标
主要结局
postoperative pain score
时间窗: 2nd postoperative day
Pain will be assessed on the 2nd postoperative day using the Visual Analogue Scale (VAS) ranging from 0 = no pain to 10 = worst pain. Patients will be instructed to rate their pain by marking a score on the 10-point VAS.
facial swelling measurement
时间窗: 2nd postoperative day
Measurements will be recorded in millimeters as: A = Gonion-Tragus B = Gonion-Outer canthus C = Gonion-Ala D = Gonion-Angle of mouth E = Gonion-Pogonion Total swelling = A + B + C + D + E. This method is described in the Operational Definition section of your synopsis.
次要结局
未报告次要终点
研究者
Huma Bajar
prinicpal investigator
Watim Medical & Dental College