Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of Postoperative Pain level From Baseline
研究概览
简要总结
The purpose of my study is to test the effect of using piezosurgery and dexamethasone injection in the surgical extraction of impacted mandibular third molars, on Postoperative Pain.
详细描述
Background: Third molar surgery is the most common procedure performed in oral and maxillofacial surgery practice.
This procedure is always associated with varying degrees of postoperative pain and swelling that may have a social impact. Traditionally, rotating instruments like burs have been used for osseous surgery.
Piezosurgery is a novel technique introduced to overcome the disadvantages associated with the conventional rotatory technique. Corticosteroids administration before or after the extraction of third molars is an efficient way to minimize postoperative pain due to their strong anti-inflammatory activity.
Many researchers conducted studies comparing the piezosurgery technique with conventional rotatory technique, regarding postoperative pain and working time, or studies comparing the conventional method with or without dexamethasone injection. Only one recent study (Nov 2018), conducted by Gümrükçü Z. et al. has compared Piezosurgery and dexamethasone injection in third molar surgery, but without evaluating the combined effect of these two techniques on postoperative pain.
Objectives: The objective of this study is to assess the effects of piezosurgery technique and intramuscular dexamethasone injection on postoperative pain in impacted third molar surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 15 to 30 years,
- •Having mandibular impacted third molars,
排除标准
- •Heavy smokers (≥20 cigarettes),
- •Uncontrolled systemic conditions,
- •Infection of the surgery site,
- •Psychological problems,
- •History of allergy to dexamethasone, amoxicillin, or acetaminophen.
研究组 & 干预措施
Rotatory Instruments without Dexamethasone injection
Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy without Intramuscular Dexamethasone injection
干预措施: Conventional Rotatory instruments (Procedure)
Rotatory Instruments with Dexamethasone injection
Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy with 8 mg Intramuscular Dexamethasone injection 30 min before surgery
干预措施: Dexamethasone injection (Drug)
Piezosurgery technique without Dexamethasone injection
Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique without Intramuscular Dexamethasone injection
干预措施: Piezosurgery (Procedure)
Piezosurgery technique without Dexamethasone injection
Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique without Intramuscular Dexamethasone injection
干预措施: Conventional Rotatory instruments (Procedure)
Piezosurgery technique with Dexamethasone injection
Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique with 8 mg Intramuscular Dexamethasone injection 30 min before surgery
干预措施: Dexamethasone injection (Drug)
Piezosurgery technique with Dexamethasone injection
Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique with 8 mg Intramuscular Dexamethasone injection 30 min before surgery
干预措施: Piezosurgery (Procedure)
结局指标
主要结局
Change of Postoperative Pain level From Baseline
时间窗: Days 1, 3, and 7 Post-op
Postoperative Pain level using Visual Analogue Scale (VAS): 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain
Working time
时间窗: Per-op
Surgery time from the start of the incision until the end of the suturing (min).
次要结局
- Change oh The maximal mouth opening From Baseline(At Day 0 and Day 3)
研究者
Wissam Nehme
Head of Oral and Maxillofacial Surgery Department
Central Military Healthcare - Oral and Maxillofacial Surgery Department