Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Postoperative inflammation following third molar surgical extraction
研究概览
简要总结
Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain, that lead to a decrease in patients' quality of life. Therefore, the use of drugs is essential to reduce the morbidity associated with surgery, with NSAIDs and corticosteroids being the most commonly used drugs.
详细描述
Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain. Traditionally, NSAIDs have been used for the treatment of postoperative pain and inflammation, although corticosteroids are increasingly used in oral surgery, as they have proven to be clinically effective in reducing postoperative complications without causing serious adverse effects. Although numerous studies have been carried out comparing different corticosteroids in order to determine which of them is the most effective, there is still no clinical protocol regulating the use of these drugs in oral surgery. Therefore, this clinical trial is based on comparing two of the most studied corticosteroids used in oral surgery to date: dexamethasone and methylprednisolone.
This study is based on the preoperative administration of 8mg of dexamethasone or 40mg of methylprednisolone via submucosa, randomly, in patients undergoing surgical extraction of a retained lower third molar, to determine which of these two drugs is more effective in the prevention of inflammation, trismus and postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 18 years of age
- •Indication for surgical extraction of a retained lower third molar
排除标准
- •Patients treated with corticosteroids in the last 3 months
- •Patients treated with NSAIDs in the last 7 days
- •Patients with hypersensitivity to the drug
- •Patients with a medical condition that contraindicates the administration of the drug
研究组 & 干预措施
Methylprednisolone group
Preoperative administration of 40mg of methylprednisolone via submucosa
干预措施: MethylPREDNISolone 40 Mg/mL Injectable Suspension (Drug)
Dexamethasone group
Preoperative administration of 8mg of dexamethasone via submucosa
干预措施: Dexamethasone 4 Mg/mL Injectable Solution (Drug)
结局指标
主要结局
Postoperative inflammation following third molar surgical extraction
时间窗: 7 days
Postoperative swelling was determined by measuring tragus-chin distance, tragus-labial cleft distance and eye angle-jaw angle distance, using a millimeter ruler.
Postoperative trismus following third molar surgical extraction
时间窗: 7 days
Postoperative trismus was assessed by measuring the patient's maximum mouth opening (measuring the distance between the incisal edge of the upper central incisor and the lower central incisor) using a millimeter ruler.
Postoperative pain following third molar surgical extraction
时间窗: 7 days
Postoperative pain was measured using the Visual Analogue Scale (VAS): patients were asked to assign a numerical value from 0-100 (0 being no pain and 100 the maximum pain).
次要结局
未报告次要终点
研究者
Unai Fernández Martín
Principal Investigator
Universidad de Granada