跳至主要内容
临床试验/CTRI/2024/04/065648
CTRI/2024/04/065648尚未招募Phase 3 4

Comparative assessment of efficiency and patient tolerance of hybrid arch bar, Erich’s arch bar and MMF screw placement in treatment of jaw fractures

Dr. D Y Patil dental college and hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年4月22日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Gingival inflammation

研究概览

简要总结

A prospective randomized controlled clinical trial to be conducted on 45 patients with maxillofacial fractures requiring maxillomandibular fixation were split into 3 groups of 15 each. Patients in group A will be treated with Erich arch bar, patients in group B with MMF screws and patients in group C with hybrid arch bar. Factors to be assessed are gingival inflammation on day of removal and 7 days post removal of MMF appliance using modified gingival index, time taken for placement and removal in minutes and patient discomfort using visual analog scale.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with maxillofacial fractures requiring maxillomandibular fixation.

排除标准

  • Patients with comminuted fractures of factial bones.
  • parhological fractures, edentulous ridges.
  • Patients with metabolic disorders, bleeding disorders, history of radiotherapy or chemotherapy.

结局指标

主要结局

Gingival inflammation

时间窗: 4 weeks post operative and 5 weeks post operative

次要结局

  • Time taken for application of MMF appliance(Day 0)
  • Time taken for removal of MMF appliance(4 weeks Post op)
  • Patient discomfort(4 weeks post op)

研究者

发起方
Dr. D Y Patil dental college and hospital
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

CSSherwin Samuel

Dr. D Y Patil dental college and hospital

研究点 (1)

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