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临床试验/CTRI/2024/08/072635
CTRI/2024/08/072635尚未招募3 期

Comparison of Skeletal Stability between Single-plate osteosynthesis and double-plate osteosynthesis in anterior mandibular osteotomies -A randomised clinical trial

saveetha dental college and hospitals1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年8月24日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
26
试验地点
1
主要终点
skeletal stability with cephalometric landmarks, at immediate post op and 6 months postbop

研究概览

简要总结

The present randomized control trial aims to fill this void in literature by  comparing the quantitative treatment outcome like skeletal stability achieved by using the traditional method of double plate osteosynthesis and a relatively new technique of single plate osteosynthesis in anterior mandibular osteotomies.

No available literature reports a comparison between the aforementioned techniques, making this trial a novel idea.

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
15.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • The study includes subjects aged 18 to 50, male or female, requiring anterior mandibular osteotomies (subapical osteotomies and genioplasties) for correction of skeletal mandibular deformities, and systematically healthy individuals.

排除标准

  • Subjects with known systemic diseases, subjects who are mentally challenged, pregnant women, and lactating women.
  • Patients undergoing genial corrections in transverse directions for facial asymmetry correction.
  • Patients with cleft and craniofacial syndromes.

结局指标

主要结局

skeletal stability with cephalometric landmarks, at immediate post op and 6 months postbop

时间窗: preop , immediate post op, 6 months post op

次要结局

  • neuromuscular disturbances(ease of surgery)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Raparthy Bhuvan Chandra

Saveetha Dental College and Hospitals

研究点 (1)

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