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临床试验/CTRI/2024/04/066072
CTRI/2024/04/066072尚未招募4 期

Analysing the Efficacy of BRIUS® Appliance in comparison to Conventional Labial and Lingual Appliance – A Finite Element Analysis and Clinical Validation

Dr Shakfi Rahman1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年4月30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
21
试验地点
1
主要终点
To assess biomechanical efficiency of BRIUS® using FEM analysis in Class I bimaxillary protrusion cases, requiring all 1st premolar extractions

研究概览

简要总结

In this study Finite Element Model Analysis will be done on  BRIUS Appliance to assess the biomechanical efficiency of the appliance  and the dental, dentoalveolar and soft tissue changes seen in the treatment with BRIUS appliance will be compared with that of the conventional labial and lingual appliance in patient with Class I bimaxillary protrusion with crowding less than 5 mm.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Class I bimaxillary protrusion cases requiring 1st premolar extraction with mild crowding cases (less than 5mm) Good gingival and periodontal health status.

排除标准

  • Periodontally compromised patient Craniofacial disorder Patient with any systemic disease Moderate to severe crowding (more than 5mm).

结局指标

主要结局

To assess biomechanical efficiency of BRIUS® using FEM analysis in Class I bimaxillary protrusion cases, requiring all 1st premolar extractions

时间窗: TO-Before treatment | T1-After treatment | (12-18months)

次要结局

  • To assess biomechanical efficiency of BRIUS® using FEM analysis in Class I bimaxillary protrusion cases, requiring all 1st premolar extractions(TO-Before treatment)
  • To assess the clinical changes in dental and dentoalveolar parameters with BRIUS® appliance when compared to the conventional Labial and Lingual appliance in Class I bimaxillary protrusion cases, requiring all 1st premolar extractions(TO-Before treatment)
  • To assess the soft tissue changes with BRIUS® appliance when compared to the Conventional Labial and Lingual appliance in Class I bimaxillary protrusion cases, requiring all 1st premolar extractions(TO-Before treatment)
  • To assess patient compliance(Mid treatment)

研究者

发起方
Dr Shakfi Rahman
申办方类型
Other [self funded]
责任方
Principal Investigator
主要研究者

Dr Shakfi Rahman

Manav Rachna Dental College

研究点 (1)

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