Comparison of Electrocautery and Scalpel Blade Incisions on Postoperative Pain, Intraoperative Blood Loss, and Wound Healing Following Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
This randomized controlled trial aims to compare electrocautery and scalpel blade incisions during surgical extraction of impacted mandibular third molars. The study will evaluate postoperative pain, intraoperative blood loss, and wound healing in patients undergoing third molar surgery. A total of 78 participants will be randomly allocated in a 1:1 ratio to receive either a scalpel blade incision or an electrocautery incision under standardized surgical conditions.
详细描述
Surgical extraction of impacted mandibular third molars is one of the most common procedures in oral and maxillofacial surgery. The type of incision used may influence postoperative outcomes, including pain, bleeding, and wound healing. Electrocautery offers simultaneous cutting and coagulation, potentially reducing intraoperative blood loss and improving surgical visibility, whereas scalpel incisions produce precise tissue cuts without thermal injury.
This prospective, two-arm, parallel-group, randomized controlled trial will compare electrocautery and scalpel blade incisions in patients undergoing surgical extraction of impacted mandibular third molars. Seventy-eight participants will be randomly assigned to either Arm A (scalpel blade incision) or Arm B (electrocautery incision). All other surgical and perioperative variables, including local anesthesia, flap design, irrigation, suture material, and postoperative medications, will be standardized.
The primary outcome is postoperative pain assessed using a Visual Analogue Scale at 24 hours, 48 hours, and 7 days. Secondary outcomes include intraoperative blood loss and wound healing assessed using the Landry Wound Healing Index at 1 and 4 weeks. The findings of this study will provide evidence regarding the most appropriate incision technique for impacted mandibular third-molar surgery.
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
- Single (Outcomes Assessor)
盲法说明
This is a single-blinded randomized controlled trial. The independent outcome assessor responsible for wound-healing and postoperative assessments will remain blinded to treatment allocation. The operating surgeon cannot be blinded because the incision techniques are visibly different.
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients.
- •Age 15 to 65 years.
- •Patients requiring surgical extraction of an impacted mandibular third molar. Patients classified as ASA I or ASA II.
- •Patients willing to provide written informed consent, or assent with parent/guardian permission where applicable, and attend scheduled follow-up visits
排除标准
- •* Patients with uncontrolled systemic disease or immuno-compromised status.
- •Patients with bleeding disorders or those taking anticoagulant/antiplatelet drugs that cannot be safely withheld according to physician advice.
- •Patients with pacemaker or implanted electrical cardiac device.
- •Pregnant or lactating patients.
- •Patients with acute infection, pericoronitis, facial space infection, or pus discharge at the surgical site at the time of surgery.
- •Patients requiring bilateral third-molar extraction in the same sitting.
- •Patients unwilling to participate or unable to return for follow-up.
结局指标
主要结局
postoperative pain
时间窗: 24 hours, 48 hours, and 7 days after surgery.
Postoperative pain at the surgical site will be assessed using a 0-10 Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain
次要结局
- intraoperative blood loss(During surgery (from first incision to final suture).)
- wound healing(1 week and 4 weeks after surgery.)