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临床试验/CTRI/2025/02/080090
CTRI/2025/02/080090尚未招募4 期

Comparative Evaluation of Self Drilling Titanium Screw Vs Conventional Screw for Open Reduction and Internal Fixation in Mid Face Fractures

Faculty of Dental Science, Dharmsinh Desai University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年2月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Stability of Fixation

研究概览

简要总结

This randomized controlled study compares the efficacy and safety of self-drilling titanium screws and conventional screws in managing maxillofacial fractures. Self-drilling titanium screws show better outcomes in terms of stability, reduced surgical time, and fewer complications compared to conventional screws.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
1.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of both genders in the age group of less than 60 years.
  • Patients who needs Open Reduction And Internal Fixation (ORIF) in mid face fractures.
  • Patients who maintain satisfactory oral hygiene and are co-operative.
  • Patients who could come for regular follow up.

排除标准

  • Patient who have any uncontrolled systemic condition that may contraindicate surgery.
  • Systemic bone diseases such as osteoporosis, osteopenia, osteopetrosis.
  • Patients under long-term corticosteroid or bisphosphonate therapy.

结局指标

主要结局

Stability of Fixation

时间窗: At baseline

次要结局

  • Complication Rate(2 days, 1 week, 4 week, 3 months, 6 months)

研究者

发起方
Faculty of Dental Science, Dharmsinh Desai University
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Maitry Negi

Faculty of Dental Science, Dharmsinh Desai University

研究点 (1)

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