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临床试验/CTRI/2019/08/020942
CTRI/2019/08/020942尚未招募不适用

Evaluation of treatmetn outcome of Forsus in developing skeletal Class III malocclusion - a pilot study

Oo DGAFMS1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年2月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Correction of skeletal class III malocclusion

研究概览

简要总结

Subjects found suitable in the above 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 for maxillary and mandibular arch shall be recorded.

Fixed orthodontic appliance will be placed on both maxillary and mandibular arch. After ascertaining the full slot engagement with SS wire, Forsus appliance will be placed in inverted position (reverse to conventional position used for Class II correction). On achieving satisfactory profile improvement / correction in overjet, post functional treatment records (T2) in the form of Photographs (extraoral&intraoral), Radiographs i.e  OPG, Lateral Cephalogram, Dental Models for maxillary and mandibular arch shall be obtained. Pre treatmentand post functional treatment lateral Cephalogramshall be analyzedusing various cephalometric values to ascertain the corrections achieved. Corrections achieved will be quantified and will be grouped as Skeletal, Dental & Soft Tissue changes. Any change in the upper air way will also be ascertain using acoustic pharyngometry.

In order to reduce the Dental effects of Forsus appliance and to achieve more skeletal results, indirect anchorage will be obtained using TADs (temporary anchorage devices).

研究设计

研究类型
Observational

入排标准

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

入选标准

  • i)Developing skeletal class III malocclusion (ANB 0â° to -4â°) ii)Maxillary deficiency with SNA <78â° (with or without mandibular prognathism) iii)Angle Class III molar/ super Class I relation with or without anterior crossbite iv)Minimal or no crowding in maxillary mandibular anterior v)Permanent dentition with no missing teeth (except 3rd molars) vi)Patients with CVMI stage 3 and above vii)No history of previous orthodontic treatment.

排除标准

  • i)Systemic condition affecting growth and development of jaws ii)Previous history of orthodontic treatment iii)Syndromic cases.

结局指标

主要结局

Correction of skeletal class III malocclusion

时间窗: after 6 months of appliance placement

次要结局

  • skeletal, dental soft tissue changes(after 6 months of appliance plaement)

研究者

发起方
Oo DGAFMS
申办方类型
Government funding agency

研究点 (1)

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