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临床试验/NCT06622642
NCT06622642尚未招募不适用

Efficacy of Transoral Versus Transbuccal Technique for Fixation of Mandibular Angle Fracture in Terms of Mouth Opening and Radiographic Gap and Displacement

Services Institute of Medical Sciences, Pakistan2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
68
试验地点
2
主要终点
Mean of mouth opening

研究概览

简要总结

The goal of this clinical trial is to learn if transbuccal technique for mandibular angle fracture is better than transoral technique. The main questions it aims to answer are:

  • Does transbuccal technique provide better mouth opening than transoral technique
  • Radiographic gap and displacement between fracture lines is more prevalent in transoral technique than transbuccal technique postoperatively Researcher will compare both the techniques to see if transbuccal technique works better than transoral technique

Participants will:

  • Be assessed 1 week , 1 month and 3 months postoperatively
  • Their mouth opening will be assessed by measuring interincisal opening with ruler
  • Radiographic gap between fracture segments and displacement of fractured segments will be measured on OPG through ruler

详细描述

OBJECTIVE: To compare the efficacy of transoral versus transbuccal technique for fixation of mandibular angle fracture in terms of mouth opening and radiographic gap and displacement.

OPERATIONAL DEFINITIONS:

MANDIBLE ANGLE FRACTURE:Fracture line in area bound from the anterior border of the masetter(distal of 2nd molar) to posterior border of the masetter assessed clinically through palpation and radiographically through OPG and PA mandible.

EFFICACY: The efficacy of the two procedures will be assessed on 1 week, 1 month, 3 months with following outcomes.

  1. MOUTH OPENING: Mouth opening will be defined as maximum interincisal distance measured in millimeters through ruler.
  2. GAP BETWEEN FRACTURE SEGMENTS: Gap between proximal and distal fracture lines measured in millimeters in OPG with ruler.
  3. DISPLACEMENT OF FRACTURE SEGMENTS: Presence of step between distal and proximal segments in vertical plane at the lower border on OPG.

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
Single (Participant)

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.All dentate and partially dentate patients with unilateral mandibular angle fracture.
  • Both isolated mandibular angle fractures and mandibular angle fractures associated with other facial fractures will be included

排除标准

  • 1.Comminuted mandibular angle fractures.
  • 2.Edentulous patients.
  • Gross external laceration in submandibular region.
  • 4.Presence of local bone pathology alongwith fracture will be excluded from study.

结局指标

主要结局

Mean of mouth opening

时间窗: 1 week, 1 month, 3 month

Mouth opening will be defined as maximum interincisal distance measured in millimeters through ruler.

MEAN OF GAP BETWEEN FRACTURE SEGMENTS

时间窗: 1 week, 1 month, 3 month

Gap between proximal and distal fracture lines measured in millimeters in OPG with ruler.

MEAN OF DISPLACEMENT OF FRACTURE SEGMENTS:

时间窗: 1 week, 1 month, 3 month

Presence of step between distal and proximal segments in vertical plane at the lower border on OPG.

次要结局

未报告次要终点

研究者

发起方
Services Institute of Medical Sciences, Pakistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Shanza Rehman

OMFS Resident

Services Institute of Medical Sciences, Pakistan

研究点 (2)

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