Efficacy of Serratiopeptidase After Surgical Removal of Mesioangular Mandibular Third Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Postoperative Facial Swelling
研究概览
简要总结
This randomized controlled trial was conducted to compare the effect of serratiopeptidase versus no intervention on postoperative mouth opening, swelling, and trismus following surgical removal of mesioangular mandibular third molars.
详细描述
A total of 110 patients undergoing surgical extraction of mesioangular mandibular third molars were randomly assigned into two groups. Group A received serratiopeptidase postoperatively, while Group B received no enzyme therapy. Mouth opening was measured postoperatively and compared between the two groups to assess the effectiveness of serratiopeptidase in reducing trismus and postoperative swelling.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Patients aged 18 to 40 years.
- •Patients requiring surgical removal of a mesioangular impacted mandibular third molar.
- •Patients who are systemically healthy (ASA I or II).
- •Patients willing to participate and provide written informed consent.
- •Patients who can comply with postoperative follow-up visits.
排除标准
- •Patients with systemic diseases affecting healing (e.g., diabetes, immunocompromised state).
- •Pregnant or lactating women.
- •Patients with known allergy or hypersensitivity to serratiopeptidase.
- •Patients on long-term anti-inflammatory or steroid medication.
- •Presence of acute infection at the surgical site.
- •Patients who have taken anti-inflammatory drugs within 48 hours before surgery.
研究组 & 干预措施
Serratiopeptidase Group
Patients in this group received serratiopeptidase postoperatively after surgical removal of a mesioangular mandibular third molar in addition to standard postoperative care.
干预措施: Standard Postoperative Care (Other)
Serratiopeptidase Group
Patients in this group received serratiopeptidase postoperatively after surgical removal of a mesioangular mandibular third molar in addition to standard postoperative care.
干预措施: Serratiopeptidase (Drug)
Control Group
Patients in this group received standard postoperative care without the administration of serratiopeptidase following surgical removal of a mesioangular mandibular third molar.
干预措施: Serratiopeptidase (Drug)
结局指标
主要结局
Postoperative Facial Swelling
时间窗: Postoperative Day 1, Day 3, and Day 7
Change in facial swelling measured using standardized facial measurements between fixed anatomical landmarks following surgical removal of a mesioangular mandibular third molar, comparing the serratiopeptidase group and the control group.
次要结局
未报告次要终点