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临床试验/CTRI/2022/06/043230
CTRI/2022/06/043230已完成不适用

Efficacy of Methylprednisolone Administration into Masseter Muscleversus Deltoid Muscle on Postoperative Sequelae in Minor Oral Surgery: ARandomized Controlled Trial

The Director1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年6月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
1. Comparison of mean pain intensity scores of group 1 and group 2 as assessed by visual analogue scale.

研究概览

简要总结

The aim of the randomized controlled trial is to compare efficacy of methylprednisolone administration in masseter muscle versus deltoid muscle on postoperative sequalae in minor oral surgery. Patients with partially or completely bony/soft tissue impacted mandibular third molars with age group of 20-40 years will be included in the study. The primary and secondary parameters for comparison includes pain, facial edma, maximum interincisal opening, wound healing assessment and total number of postoperative analgesics taken by patient. Clinical assessment of the patients will be done on the day of surgery and first, third and seventh day postoperatively.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Partially or completely bony/soft tissue impacted mandibular third molars.
  • Age group 20-40 years.

排除标准

  • Acute infection of odontogenic and non-odontogenic causes.
  • Pregnant and lactating females.
  • Patients with known systemic disorder such as diabetes mellitus, hypertension, thyroid disorder, immunocompromised state etc.

结局指标

主要结局

1. Comparison of mean pain intensity scores of group 1 and group 2 as assessed by visual analogue scale.

时间窗: Preoperatively on the day zero (day of surgery) and on the first, third, and seventh post-operative days.

2. Comparison of facial edema as assessed by mean distance between : Tragus and lip commissure, tragus and soft tissue pogonion, gonion and external canthus of eye of group 1 and group 2.

时间窗: Preoperatively on the day zero (day of surgery) and on the first, third, and seventh post-operative days.

3. Comparison of mean values of maximum interincisal opening of group 1 and group 2.

时间窗: Preoperatively on the day zero (day of surgery) and on the first, third, and seventh post-operative days.

次要结局

  • 1. Comparison of mean scores of wound healing of group 1 and group 2 as assessed by healing index by Landry et al.(2. Comparison of total number of postoperative analgesics taken for group 1 and group 2.)

研究者

发起方
The Director
申办方类型
Government medical college

研究点 (1)

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