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临床试验/CTRI/2021/01/030399
CTRI/2021/01/030399已完成不适用

Comparative evaluation of clinical efficacy of two fixed functional appliances for treating 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 60 人开始时间: 2021年1月15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
2
主要终点
Correction of Skeletal Class II malocclusion

研究概览

简要总结

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 late stages of puberty with minimal growth left, fixed functional appliances are a treatment of choice. They are often called "non-complaint 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 AdvanSync 2 is the latest addition to the orthodontist’s armamentarium. It comprises of several modifications in the original AdvanSync appliance to deliver latest, simple and efficient Class II correction. A bonus that came out of this new smaller design of this appliance was the ability to bracket every tooth anterior to this appliance that has allowed orthopaedic correction along with simultaneous orthodontic correction resulting in reduced treatment time by almost 06 months in correction of malocclusion. Apart from few case reports there is no published study which compares the AdvanSync2 appliance with FORSUS FRD appliance. Thus, the purpose of this pilot study is to evaluate clinical efficacy of AdvanSync2 appliance in the treatment of skeletal class II malocclusion and compare with FORSUS FRD. The null hypothesis is that there is no significant difference in treatment effects between Forsus and AvanSync2.

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-VI
  • 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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