To Compare Efficacy of Low Dose Diclofenac (25mg) in Management of Postoperative Pain After Periodontal Flap Surgery: A Clinical Trail.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- visual analog scale VAS
研究概览
简要总结
Pain after periodontal surgical procedures is a common manifestation. The perception of pain is highly subjective and varies substantially among individuals. Many factors affect pain perception, such as the nature, duration, and extent of the surgery and psychological aspects (e.g., stress and anxiety). Pain after periodontal surgery is an example of acute dental pain of mild to moderate severity. Non-steroidal anti-inflammatory drugs (NSAIDs) have a significant advantage in the control of pain after periodontal or oral surgical procedures.
Diclofenac is a powerful anti-inflammatory and analgesic drug that is well suited for local use in the oral cavity. Diclofenac competes with arachidonic acid in a dose dependent manner for binding with platelet COX. This results in decreased production of PG and thus reduces inflammation, swelling and pain.
As Diclofenac associated with many adverse effects, like gastric irritability, nausea, headache, dizziness. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. As many of clinical trials have suggested Diclofeanc 50 mg alleviates the postoperative pain. So main aim of the study was to evaluate the effectiveness of low dose Diclofenac(25mg) in reducing the post operative pain after periodontal flap surgeries. Thus comparing the effects of low dose Diclofenac and Diclofenac 50mg for reducing post-operative pain.
详细描述
The present split mouth, single blind randomized controlled clinical trial was carried out in the
Department of Periodontology and source of the patients was from the outpatient section of Tatyasaheb Kore Dental College & Research Centre, New Pargaon.
Patients were enrolled in the study between November 2016 and June 2017. Based ' on the power of study that was l 80% with alpha of 0.05 with SD of ±1.47, we required
18 experimental quadrants and 18 control quadrants. Considering 10% dropout " sample size was finalized at 20.
The study included 20 patients [14 males and 6 females] with generalized chronic periodontitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
patient were masked for which tablet they were reciving during the study.
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generalized moderate/severe chronic periodontitis
- •The probing depth (PD) of the surgical sites in the both group ranged from 5 to 8 mm.
- •The clinical attachment level (CAL) at the surgical sites in both the group ranged from 5 to 9 mm.
- •Quadrant with the presence of atleast 6 teeth will be selected for study.
排除标准
- •Tobacco in any form and alcoholics.
- •Pregnant and lactating mother.
- •Patients with history of systemic ailments, patients under ant-inflammatory/antibiotic 3 months prior to recruitment for study.
- •Subjects who had received periodontal treatment within the previous 6 months.
- •Patient who have history of intolerance or hypersensitivity to Diclofenac and with gastric diseases
研究组 & 干预措施
study group one side
All patients were scheduled for open flap debridement surgery on at least two quadrants ≥1 weeks apart.One group will receive Low Dose Diclofenac tablets (25mg Diclofeanc and 325 mg paracetamol), BID for 3 days. The patients who are diagnosed with generalized moderate/severe chronic periodontitis will be included in study. For each quadrant, a flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia will be employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure will be recorded in the patient file. Patients will be instructed to complete a pain diary chart for 3 days.
干预措施: low dose diclofenac (Drug)
study group second side
Other group will receive Diclofeanc (50mg Diclofenac and 325mg paracetamol), BID for 3 days. The patients who are diagnosed with generalized moderate/severe chronic periodontitis were included in study. For each quadrant, aperiodontal flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia will be employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure was recorded in the patient file. Patients were instructed to complete a pain diary chart for 3 days.
干预措施: low dose diclofenac (Drug)
结局指标
主要结局
visual analog scale VAS
时间窗: 3 days
it messures pain intensity it is an 10cm line anchored by two extremes 0 for no pain and 10 for extreme pain
次要结局
未报告次要终点
研究者
Dr.Kshitij .K. Karmkar
Principle investigator
Tatyasaheb Kore Dental College