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临床试验/NCT03296644
NCT03296644已完成不适用

"Evaluation of Treatment Effects of Two Different Fixed Functional Appliances in Patients With Class II Div 1 Malocclusion Using CBCT- A Randomized Controlled Clinical Study"

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
condylar changes

研究概览

简要总结

The main objective of this prospective, controlled clinical study is:

  1. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device in patients with Class II divison1 malocclusion.
  2. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device with the control group.

The null hypothesis for this study is that Forsus and PowerScope2 are equally effective in the treatment of ClassII div1 malocclusion.

详细描述

Class II malocclusion is one of the most frequent problems in orthodontics ,as it affects one third of patients seeking orthodontic treatment. McNamara reported mandibular retrusion as the most common characteristic of Class II malocclusion rather than maxillary prognathism. Functional orthopaedic appliances are widely used to treat Class II malocclusion in growing patients .Contrary to removable appliances, fixed devices do not require patient collaboration and can be worn in association with multibracket therepy, so that class II malocclusion can be corrected in a single phase treatment.

.Most popular flexible devices are the Jasper Jumper, Eureka spring, and the Forsus device (FRD)Forsus Fatigue Resistant Device [FRD]is a three piece (L pin module) or two-piece (EZ2 module) system, composed of a telescoping spring that attaches at upper first molar and a push rod linked to lower archwire, distal to either the canine or first premolar bracket. The FRD spring and rod create an equal and opposite force to maxillary and mandibular dentition.1The clinical application of the FRD was described by Vogt in 2006.PowerScope is one of the latest innovation in Class II correction developed by Dr. Andy Hayes. Inventors claims the following advantages of powerscope over other functional appliances. It is delivered as a one-size-fits-all appliance pre-assembled with attachment nuts for quick and easy chairside application .

The appliance is a wire-to-wire installation with attachments placed mesial to the first molar in the maxillary arch and distal to the canine of the mandibular arch. Internal NiTi spring mechanism delivers 260 gms of force for continous activation during treatment.

The dental, skeletal and soft tissue short-term effects of comprehensive fixed appliance treatment combined with ForsusTM in ClassII patients have been evaluated previously. However no previous study compared the posttreatment effects of PowerScope2TM and ForsusTM.The purpose of this controlled clinical study is to evaluate the treatment and posttreatment effects induced by PowerScope2 in growing patients with ClassII malocclusion and to compare it with Forsus(FRD) on CBCT.

The majority of the studies examined the changes of the upper airway through lateral cephalometric radiography. This method limited the accuracy of airway measurement since the two-dimensional (2D) images only allowed an anteroposterior dimension measurement in sagittal plane, and failed to provide a full-scaled view of the upper airway. Therefore, 3D evaluation of the upper airway in growing patients during fixed functional appliance treatment needs to be established .Cone beam computed tomography (CBCT) is an acceptable technique for 3D volumetric depiction and morphological evaluation of the upper airway using a lower-radiation method with a greater spatial resolution . It allows 3D registration of pre- and post-treatment data through identification of specific structures in the cranial base. Therefore, the changes of the upper airway before and after mandibular advancement can be precisely evaluated. As the patients involved in our research were underage, their normal development may affect on the upper airway morphology during the treatment period. Thus, an untreated control group is needed. In the present study, the control group was selected from records of patients with the same diagnosis who just began orthodontic treatment, and matches well with the post-treatment patients of fixed functional appliance group through age, sex and development condition strategy, so that effects of fixed functional appliance on the upper airway morphology can be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients in active growth period
  • Skeletal Class II malocclusion
  • Normal or mildly prognathic maxilla
  • Retrognathic mandible.
  • Increased overjet, not less than 5 mm.
  • Horizontal to average growth pattern
  • Positive pretreatment visual treatment objective (VTO).
  • Minimum crowding in dental arches.
  • Treatment completed without any permanent teeth extracted (excluding third molars).

排除标准

  • Subjects with a history of orthodontic treatment
  • Anterior open bite
  • Severe proclination and crowding of anterior teeth
  • Any systemic disease affecting bone and generalgrowth
  • Vertical growth pattern
  • Patient who fails to follow up or undergo complete treatment

研究组 & 干预措施

PowerScope2 group (G1)

Active Comparator

Class II correction using PowerScope2

干预措施: Class II correction using PowerScope2 (Device)

Forsus group (G2)

Active Comparator

Class II correction using Forsus

干预措施: Class II correction using Forsus (Device)

结局指标

主要结局

condylar changes

时间窗: 20 months

condylar changes after intervention

patient experiences

时间窗: 20 months

patient experiences with Forsus and PowerScope

mandibular length

时间窗: 20 months

changes in mandibular length after intervention

oropharyngeal volume

时间窗: 20 months

changes in oropharyngeal volumes after intervention

pancherz analysis

时间窗: 20 months

pancherz analysis after intervention

soft tissue changes

时间窗: 20 months

soft tissue changes after intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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