Evaluation of the effectiveness of biphasic versus monophasic aceclofenac, paracetamol and serratiopeptidase following mandibular third molar extraction - A randomised controlled trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
This study is a prospective, randomized, double-blind clinical trial comparing the efficacy of biphasic versus monophasic aceclofenac, paracetamol, and serratiopeptidase in managing postoperative pain, swelling, and gastrointestinal discomfort following mandibular third molar extraction.
Thirty patients will be randomly allocated into two groups receiving either the biphasic or monophasic formulation. Pain (VAS), swelling (tape measurements), and gastrointestinal discomfort (Bothersomeness Scale) will be assessed on postoperative Day 1 and Day 3. The primary objective is to compare the clinical effectiveness of both formulations, with secondary outcomes including gastrointestinal discomfort, rescue analgesic requirement, and patient compliance. Data will be analyzed using unpaired t-test and Mann–Whitney U test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Indicated for mandibular third molar extraction.
- •Patients willing to provide informed consent and comply with follow-up.
排除标准
- •Known allergy or intolerance to study drug components.
- •Medically compromised patients
- •Pregnant or lactating females.
- •History of chronic NSAID or steroid use.
研究者
Dr Abhilasha Lad
Dr DY Patil Dental College and Hospital, Dr DY Patil Vidyapeeth, Pimpri, Pune 411018.