跳至主要内容
临床试验/CTRI/2023/09/057215
CTRI/2023/09/057215尚未招募3 期

Comparative assessment of improvement in masticatory efficiency in patients with anterior mandibular fractures treated with four-hole versus six-hole mini plate fixation. A pilot randomized control trial.

ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR CG1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年9月9日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
12
试验地点
1
主要终点
Bite Force

研究概览

简要总结

The mandible is the second most common fractured bone over the facial region after the nose. Road traffic accidents, assaults, and falls from height are common causes of mandibular fractures. Of about 15.1% of reported cases of anterior mandibular fractures, symphysis and parasymphysis fractures account for 2.85% and 12.16%, respectively. A fractured mandible undergoes compression, tension, and torsion due to different muscle forces. Mandibular fracture treatment aims to restore anatomical form and function and re-establish the occlusion, thereby improving the bite force. According to AO (Arbeitsgemeinschaft für Osteosynthesefragen), sufficient internal fixation hardware must be applied to resist the maximum forces of mastication. Recommendations for the amount of fixation hardware necessary to treat fractures of the mandible vary widely—the size of plates (thickness, length, number of holes). The diameter and length of screws, and the number of plates used for anterior mandible fractures differ from surgeon to surgeon. Measuring bite force is an excellent assessment criterion for restoring bony architecture and healing of masticatory soft tissue. Champy and colleagues advocated a modification of Michelet’s miniplate osteosynthesis technique and described ideal lines of osteosynthesis. A standard protocol of osteosynthesis is to use two 4-hole mini plates in anterior inter-foraminal fractures. One at the tension zone and one at the compression zone. Disadvantages of miniplate usage include chances of buccolingual splaying and gap formation at the inferior border. Our study plans to assess the bite force primarily along with pain, swelling, stability and buccolingual splaying if one 4-hole plate was to be placed subapically and a 6-hole mini plate was placed at the inferior border.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant Blinded

入排标准

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

入选标准

  • •Patients above 14 years of age.
  • •Anterior mandible fracture.

排除标准

  • •Comminuted/ Infected fractures Edentulous patients Fractures involving the maxilla, and other sites of the mandible.
  • •Dentoalveolar fractures which may potentially affect the bite force.

结局指标

主要结局

Bite Force

时间窗: 24 hours 1 week 2 weeks & 4 weeks

次要结局

  • Pain(Occlusion)

研究者

发起方
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR CG
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验