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临床试验/CTRI/2023/05/053166
CTRI/2023/05/053166已完成不适用

Evaluation of treatment efficacy of splint-supported Forsus Fatigue Resistant Device vs Twin block in skeletal Class II growing subjects. A randomised clinical trial

Director General Armed Forces Medical Services1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月6日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Correction of Skeletal Class II malocclusion

研究概览

简要总结

Subjects found suitable in the pre determined inclusion criteria for the study shall be explained the scope of the study and a written consent shall be obtained. Pre-treatment records (T1) in the form of photographs (extraoral & intraoral), radiographs i.e., OPG, Lateral cephalogram, and dental models formaxillary and mandibular arch shall be recorded. For splint-supported FFRD group a customized splint will be fabricated on the mandibular arch and FFRD shall be installed using upper molar band and splint in lower canine region. Standard Twin block shall be given to another group. On achieving satisfactory profile improvement /correction in overjet /molar relation, post functional treatment records (T2) in the form of photographs (extraoral & intraoral), radiographs i.e., OPG, Lateral cephalogram, dental models formaxillary and mandibular arch shall be obtained.  Pre-treatment and post functional treatment lateral Cephalogram shall be analyzed using various cephalometric values to ascertain the corrections achieved. Corrections achieved will be quantified and will be grouped as skeletal, dental & soft tissue changes. In addition, the treatment duration for the study groups shall be recorded, the patient comfort & operator convenience along with frequency of breakage of appliance (if any) shall be noted.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Cases of skeletal Class II malocclusion (ANB> 4 degrees)
  • Class II or Half cusp Class II molar relation
  • Positive visual treatment objective
  • CVMI stage III
  • No missing or supernumerary teeth
  • Patients giving written consent to participate in the study
  • No h/o previous orthodontic treatment.

排除标准

  • Those refusing for written consent to participate in the study
  • Negative visual treatment objective
  • History of previous orthodontic treatment
  • Systemic diseases affecting bone metabolism
  • Patients with neuromuscular disorder & TMJ problems.

结局指标

主要结局

Correction of Skeletal Class II malocclusion

时间窗: After completion of treatment

次要结局

  • a) To compare treatment duration between the study groups(b) To compare patient comfort and operator convenience)

研究者

申办方类型
Government funding agency

研究点 (1)

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