Evaluation Of Efficacy Of Analgesics In Patients With Symptomatic Apical Periodontitis In Terms Of Number Needed To Treat: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- number needed to treat
研究概览
简要总结
The aim of the study is to use the NNT (number needed to treat) model to evaluate the efficacy of analgesics in patients with acute apical periodontitis.
Material and Methods : Patients with acute apical periodontitis (AAP) without periapical lesion, with or without PDL widening if he/she placed a mark at the 4cm or above level will be selected for the study at the dental institute. The patients were randomly allocated into 4 groups of 50 patients in each group, receiving ibuprofen 400 mg in Group B, ketorolac 10 mg in Group C and diclofenac sodium 100 mg in Group D and a control in Group A in which placebo will be given just after the completion of first appointment. A questionnaire containing the NRS will be given to each patient for them to record the intensity of pain felt after 6, 12, 24, 48 and 72 hrs interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •patient with symptoms of AAP, without periapical lesion, with or without PDL widening if he/she placed a mark at the 4cm or above level and patient undergoing root canal treatment for pain originating from anterior or posterior teeth.
排除标准
- •patients with less than 16 years or more than 65 years, patients who have consumed any type of analgesic within the last 6 h of their visit, history of allergy to NSAIDs, history of peptic ulcer disease, history of renal or hepatic disease, hemorrhagic disorders, pregnancy or breast feeding, patients with previous endodontic treatment and patients with acute apical abscess.
结局指标
主要结局
number needed to treat
时间窗: After 72 hours
次要结局
- Efficacy of different drugs at different time point(6,12,24,48 and 72 hours)
研究者
Manju Kumari
Chaudhary Charan Singh University