Assessment of effectiveness of pre-operative single dose intramuscular dexamethasone on post-operative outcomes following surgical removal of impacted lower third molar.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain, swelling and restriction in mouth opening and limitation in daily activities.
研究概览
简要总结
This study is to be conducted on 10 patients with bilateral impacted lower third molar. An IOPA and Orthophantamogram will be taken for evaluation preoperatively. Informed consent will be obtained from all patients. The impacted molars are to be removed at a one-month interval, with surgical difficulty assessed using the Pederson difficulty index and WHARFE assessment. All procedures will be performed by the same operator under local anesthesia. One side was assigned to Group A, receiving an 8mg intramuscular injection of dexamethasone one hour pre-operatively, while the contralateral side Group B served as a control, receiving no pre-operative medication. Standardized surgical and analgesic protocols were followed. Postoperative assessment for swelling, restriction in mouth opening, pain and limitation in daily activities was recorded on 2nd and 7th postoperative days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients who desire surgical extraction of bilaterally impacted lower third molar. Age group between
- •35 years. Both sexes would be included. Patient with no presenting acute systemic illness such as fever, common cold etc. Patient who are willing to participate in the study. Be available for follow up examinations. Patients with higher difficulty index of impacted teeth. greater than 5 in Pederson difficulty Index.
排除标准
- •History of systemic diseases that would contraindicate surgical treatment.
- •Compromised health conditions.
- •Patient with active infection like periapical access, pericoronitis etc.
- •Known allergy or contraindication to any of the medications to be used in the study.
- •Lack of willingness to participate in the study or lacking compliance to post-surgical instructions.
- •Patients with high risk of infection including smokers, malnutrition, immunosuppressive drugs.
- •Patients currently under steroids or having taken systemic steroids in the last 3 months.
- •Pregnancy or lactation.
结局指标
主要结局
Pain, swelling and restriction in mouth opening and limitation in daily activities.
时间窗: Intraoperatively, Postoperative day 2 and day 7
次要结局
未报告次要终点
研究者
Sai Aditiya Narayanan R
Ragas Dental College and Hospital