Efficacy of submucosal Injection Aprotonin, Hyaluronidase and Dexamethasone during third molar surgery : A randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Postoperative facial swelling measured in millimeters using linear facial measurements.
研究概览
简要总结
Patients diagnosed with impacted mandibular third molar and radiographically graded as slight and moderate difficulty in removal according to Pederson index will be included. Demographic data with detailed history will be obtained about personal, habit and medical history followed by clinical examination and parameters will be evaluated such as swelling evaluation by sum of linear measurements, mouth opening by maximal interincisal distance using vernier callipers, pain will be assessed subjectively using visual analogue scale (VAS 0-10 cm) preoperatively, at 72 hrs and after 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy ambulatory patients reporting to the Department of Dentistry, AIIMS Rajkot requiring removal of single impacted lower third molars which necessitates mucoperiosteal flap elevation, buccal bone guttering with or without sectioning of tooth, Age between 18-50 years, slight and moderate difficult impaction based on radiographs.
排除标准
- •Patients with systemic diseases, pregnancy and breast-feeding or any other medicinal therapy that could interfere with healing process, use of any antibiotic or any anti-inflammatory drug within 1 week period, patient with preoperative swelling, reduced mouth opening, any abusive habits like tobacco chewing, alcohol consumption and smoking.
结局指标
主要结局
Postoperative facial swelling measured in millimeters using linear facial measurements.
时间窗: Baseline(preoperatively),72 hrs, 7 days
次要结局
- Change in interincisal mouth opening (in mm)(Baseline(preoperatively),72 hrs, 7 days)
- Reduction in pain measured using Visual Analog Scale (VAS)(Baseline(preoperatively),72 hrs, 7 days)
研究者
Dr Shreeya Sharma
All India Institute of Medical Sciences, Rajkot, Gujarat