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临床试验/CTRI/2024/04/065925
CTRI/2024/04/065925尚未招募3 期

Comparative evaluation of skeletal and dental changes following mandibular en masse distalization with buccal shelf screws - A randomised controlled trial between two orthodontic mechanics

Nisshitha Rao Setvaji1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
18
试验地点
1
主要终点
Linear (mm) and angular (degrees) skeletal and dental changes

研究概览

简要总结

A comparative evaluation of skeletal and dental changes following mandibular en masse distalization with buccal shelf screws - A randomised controlled trial between two orthodontic mechanics

Aim: To compare and evaluate the skeletal and dental changes following lower en masse distalization with buccal shelf screws between two orthodontic mechanics

Sample size: 18 patients

Randomised controlled clinical trial

Group 1: Distalization with a statically determinate system

Group 2: Distalization with a statically indeterminate system

Methodology: Linear and angular skeletal and dental changes calculated between the pre distalization and post distalization CBCT values.

The rate of lower molar distlization to be calculated by dividing the amount of distalization by the time taken to achieve Angle’s Class l molar relationship.

Primary and secondary parameters to be measured from the pre and post distalization CBCTs and the difference between the two orthodontic biomechanics to be calculated.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
14.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Class lll skeletal and dental relationships of all growth patterns Extracted lower third molars No other missing or extracted teeth.

排除标准

  • Subjects with Class l and ll skeletal and dental relationships were excluded.
  • Subjects with facial asymmetry or asymmetrical arches were excluded.
  • Subjects with missing teeth or functional deviations on occlusion were excluded.
  • Subjects with craniofacial syndromes or physically or mentally handicapped were excluded.

结局指标

主要结局

Linear (mm) and angular (degrees) skeletal and dental changes

时间窗: Baseline, 5 months and 10 months (end of distalization).

次要结局

  • Rate of mandibular arch distalization, anterior & posterior anatomical limits, soft tissue changes, tongue position, hyoid position & airway volume changes(Baseline, 5 months & 10 months (end of distalization))

研究者

发起方
Nisshitha Rao Setvaji
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Nisshitha Rao Setvaji

Saveetha Institute of Medical and Technical Sciences

研究点 (1)

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