A comparative study to evaluate the anti-inflammatory and analgesic activity of flavonoids versus serratiopeptidase in combination with diclofenac in patients undergoing mandibular third molar surgery–A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Secondary Outcome: Swelling and Trismus
研究概览
简要总结
Surgical removal of mandibular third molar is usually associated with postsurgical sequalae that may have both biological and social impact.
Patients report common post-operative complications such as pain, swelling and trismus which affects the quality of life.
Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions
Serratiopeptidase is a widely used proteolytic enzyme in therapeutic applications. It has shown significant anti-inflammatory, anti-edemic, and analgesic effects in various areas including surgery, orthopaedics, otorhinolaryngology, gynaecology, and dentistry. It is well known amongst researchers for its caseinolytic (proteolytic) and fibrinolytic properties.
Combination of Proteolytic enzyme with Flavonoids that includes trypsin, bromelain and rutoside showed increased significance in reduction of pain and inflammation.
Studies have shown that using a proteolytic enzyme aids a better and fast healing when compared to usual anti-inflammatory drugs hence this study is done to find the anti-inflammatory and analgesic activity in combination of Enzyme and NSAIDs
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I patients in the age group of 18- 40 years with either gender
- •All impacted mandibular third molars requiring surgical extraction
- •CLASS I, CLASS II, POSITION-A and POSITION-B Impacted third molar According to Pell and Gregory classification 4.Patient willing to participate in the study.
排除标准
- •1.Acute infection 2.Patient allergic to administrated drugs 3.Patients with Gastric Ulcers 4.Patient with bleeding disorders 5.Pregnancy and Lactating women 6.Immunocompromised patient Mentally challenged patient.
结局指标
主要结局
Secondary Outcome: Swelling and Trismus
时间窗: Both Primary and Secondary outcomes are measured on the pre operative day (Day 0) and post operative days (Day 1and Day 3) that is during the course of the intervention administered and post operative days (Day 7 and Day 12) for follow up
Primary Outcome: Pain
时间窗: Both Primary and Secondary outcomes are measured on the pre operative day (Day 0) and post operative days (Day 1and Day 3) that is during the course of the intervention administered and post operative days (Day 7 and Day 12) for follow up
次要结局
- Primary Outcome: Pain(Secondary Outcome: Swelling and Trismus)
- Swelling(Trismus)