Effectiveness of Intraosseous Injection of Dexamethasone Following Impacted Mandibular Third Molar Removal (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in mouth opening
研究概览
简要总结
Thirty-eight patients were randomly divided into 2 groups; the intraosseous injection group of dexamethasone (4 mg) and the submucosal injection group. All surgeries were performed by one surgeon.
Postoperative pain was evaluated by visual analog scale score immediately after surgery and on postoperative days 1, 3, and 7.
Swelling (determined using two linear measurements) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper.
Early healing of periodontal soft tissue wound was assessed by using Early Wound Healing Score (EHS) which composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI) and were assessed on postoperative days 1, 7, and 14. Mouth opening (determined by measurement of the maximum inter-incisal distance) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient complaining of impacted mandibular third molar mesioangular or horizontal, according to the Pell and Gregory classification 1933)
- •Healthy patient (American society of anesthesiologists class I status)
- •Patient age range from 18 to 40 years old.
- •Patient without any local inflammation or pathology.
- •Patient who will able to understand verbal and written instructions.
排除标准
- •Pregnant or breast-feeding women.
- •Patient had anti-inflammatory drugs within 2 weeks before the procedure.
- •Patient under radiotherapy or chemotherapy.
- •Habits (heavy smoking and alcoholic).
- •Allergy to drugs used in this study.
- •Patient under anticoagulant or corticosteroid therapy.
研究组 & 干预措施
IO dexamethasone injection
干预措施: Intraosseus (Other)
SM dexamethasone injection.
干预措施: Submucoal (Other)
结局指标
主要结局
Change in mouth opening
时间窗: baseline, 1st, 3rd, 7th days
determined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper
change in swelling
时间窗: 1st, 3rd, 14th days
assessed by measuring two linear references (horizontal and vertical) with digital vernier caliper 1. Horizontal reference between the corner of the mouth and the tragus of the ear. 2. Vertical reference between the lateral canthus and the angle of the mandible.
change in pain scores
时间窗: 1st, 3rd, 7th days
Pain will be assessed by using a visual analog scale (VAS) (13) immediately after surgery and on postoperative days 1, 3, and 7.
次要结局
- change in early healing of periodontal soft tissue wound(1st, 7th, 14th days)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University