跳至主要内容
临床试验/CTRI/2026/01/102150
CTRI/2026/01/102150尚未招募不适用

"Comparative analysis of Retromandibular approaches to the Condyle: Transparotid versus Anteroparotid Transmasseteric Techniques"- A Randomized Controlled Trial.

Self1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年2月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
Self
入组人数
20
试验地点
1

研究概览

简要总结

This randomized controlled trial includes 20 patients (10 patients for each approach) with mandibular condylar fractures, who will undergo open reduction and internal fixation. In case of bilateral condylar fractures considering 1 fracture site as 1 patient. In all these patients, pre-operative diagnostic radiographs- 3D-CT (3 dimensional computed tomography) of the face, chest X-ray, ECG (electrocardiograph), and laboratory investigations including hematological investigations followed by post- operative OPG (orthopantomogram) scan will be done. Patients will be followed up and specified parameters will be recorded postoperatively on 1st day, 1st week, 1st month and 3rd month.

The study is designed to compare the time taken for exposing the fracture site intra-operatively and compairing post-operative complications – maximal interincisal opening, facial nerve weakness using House - Brackman Scale, infection and wound dehiscence using visual description of WUWHS SWD grading system according to tissue layers involved in the dehiscence (WUWHS, 2018), parotid fistula formation and scar using Stony Brook’s Scar evaluation scale among the two approaches. Any complications encountered during or after the surgery will be managed in accordance with standard medical protocols.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
16.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients above 16 years of age.
  • Condylar fractures indicated for open reduction and internal fixation on clinical as well as radiological basis.
  • Dentulous or partially edentulous patients .
  • Mental status permitting on adequate neuromotor examination.

排除标准

  • Patients below 16 years of age.
  • Patients with bleeding disorders, eg.
  • Haemophilia.
  • Patients with preoperative facial nerve paralysis.
  • Completely edentulous patients.
  • Patients not fit for surgery under General anesthesia.

研究者

发起方
Self
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Nishant Rathi

Subharti Dental College and Hospital

研究点 (1)

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