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临床试验/CTRI/2019/07/020050
CTRI/2019/07/020050招募中不适用

Comparative evaluation of clinical efficacy of two class II correctors in treatment of skeletal class II malocclusion. A randomised controlled trial.

Director General Armed Forces Medical Services2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Correction of Skeletal Class II malocclusion

研究概览

简要总结

Various removable and fixed functional appliances are used for correction of skeletal Class II malocclusion with retrognathic mandible in growing patients. In patients who report after the pubertal growth spurt or during the late stages of puberty with minimal growth left, fixed functional appliances are a treatment of choice. They are often called "non-compliant Class II correctors" as they require minimum patient co-operation unlike removable appliances. The Forsus FRD (3M Unitek Corp., Monrovia, Calif) is one of the most commonly used fixed functional appliance for correction of Class II malocclusion. But it is often associated with limitations like frequent breakage of canine brackets and soft tissue lacerations. It is available in various sizes, hence a large inventory must be maintained and chairside time is increased as correct size for individual patient needs to be selected. The PowerScope 2 (American Orthodontics, Sheboygan, Wis) is the latest addition to the orthodontist’s armamentarium. It comprises of several modifications in the original PowerScope to deliver latest, simple and efficient Class II correction. PowerScope 2 features a stronger wire attachment nut and visual activation indicators. It is available as a one-size-fits-all appliance, preassembled with attachment nuts for quick and easy chairside application. It provides a wire-to-wire installation with attachments placed mesial to the first molar in the maxillary arch and distal to the canine in the mandibular arch. Apart from a few case reports and clinical studies, literature evaluating the treatment efficacy of PowerScope and comparing with other fixed functional appliance like Forsus FRD is limited and at present there is no published study on the latest generation PowerScope 2. Thus, the purpose of this study is to evaluate the clinical efficacy of PowerScope 2 appliance in the treatment Skeletal Class II malocclusion and compare with Forsus FRD. The null hypothesis is that there is no significant difference in treatment effects between PowerScope 2 and Forsus.

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
12.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Cases of Class II malocclusion (ANB>4 degrees)
  • Molar relation class II/Half cusp class II
  • Overjet > 4mm
  • Positive Visual Treatment Objective
  • CVMI stage III-V
  • No missing or supernumerary teeth
  • Patients giving written consent to participate in the study
  • No h/o previous orthodontic treatment/trauma to jawbones.

排除标准

  • 1.Negative VTO 2.History of previous orthodontic treatment 3.Systemic diseases affecting bone metabolism 4.Patients with neuromuscular disorders & TMJ problems 5.Insufficient teeth/periodontal status to support the appliance.

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 chairside time taken for appliance insertion and removal between the study groups)

研究者

申办方类型
Government funding agency

研究点 (2)

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