Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Facial swelling (using 3 facial measurements (in millimeters)
研究概览
简要总结
The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients (ASA I)
- •Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification
排除标准
- •Heavy tobacco smokers
- •Drug and / or alcohol abusers
研究组 & 干预措施
Intramuscular application
Intramuscular application of 4mg Dexamethasone
干预措施: Intramuscular application (Procedure)
Submucosal application
Submucosal application of 4mg Dexamethasone
干预措施: Submucosal application (Procedure)
4mg Dexamethasone submucosal
4mg Dexamethasone submucosal application
干预措施: 4mg Dexamethasone submucosal (Drug)
8mg Dexamethasone submucosal
8mg Dexamethasone submucosal application
干预措施: 8mg Dexamethasone submucosal (Drug)
4mg Dexamethasone postoperative
4mg Dexamethasone postoperative application
干预措施: 4mg Dexamethasone preoperative (Procedure)
4mg Dexamethasone preoperative
4mg Dexamethasone postoperative application
干预措施: 4mg Dexamethasone postoperative (Procedure)
结局指标
主要结局
Facial swelling (using 3 facial measurements (in millimeters)
时间窗: 1 day, 3 day, 7 day
We followed facial swelling 1, 3 and 7 days after intervention. Swelling in the operation site will be evaluated using 3 facial measurements (in millimeters): 1. Tragus - Midline. 2. Tragus - Corner of the mouth 3. Gonion - Lateral canthus.
次要结局
- Postoperative pain (visual analog scale)(1 day, 3 day, 7 day)
- Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)(1 day, 3 day, 7 day)
- Postoperative discomfort (25-items custom made questionnaire)(4 day, 7 day)
研究者
Miroslav Andric
Assistant Professor
University of Belgrade