跳至主要内容
临床试验/CTRI/2025/02/080796
CTRI/2025/02/080796尚未招募2/3 期

Comparative study between cad-cam designed (3d printed ) versus conventional occlusal splints in reduction of displaced mandibular fractures

RIDDHI HEMANT PATIL1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1. Occlusion stability

研究概览

简要总结

This study is to make easy about operating mandibular fractures with derranged occlusion. This study aims to assess the efficacy and functionality of CAD-CAM splints in achieving precise anatomic reduction of mandibular fractures and restoring ideal pre trauma occlusion, in comparison with conventional handmade splints.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

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

入选标准

  • Patients aged between 20 and 60 years.
  • Presence of mandibular fractures with displacement Presence of post-traumatic malocclusion.

排除标准

  • Patients with undisplaced mandibular fractures.
  • Presence of post-traumatic occlusion.
  • Any underlying condition such as severe systemic diseases, inability to undergo surgery, previous mandibular surgeries.

结局指标

主要结局

1. Occlusion stability

时间窗: post op day 1 | post op day 7 | post op day 30

2. Interfragmentary distance between two displaced fractured segments post reduction to be measured intraoperatively

时间窗: post op day 1 | post op day 7 | post op day 30

次要结局

  • surgeon comfort while using the splint(patient comfort & post op occlusion)

研究者

发起方
RIDDHI HEMANT PATIL
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Riddhi H Patil

Krishna Vishwa Vidyapeeth

研究点 (1)

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