Comparative Evaluation of Treatment Effects of PowerScope and Forsus Fixed Functional Appliance in Correction of Class II Malocclusion: A Single Centre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- changes in mandibular length
研究概览
简要总结
The objective of this 2-arm parallel double blinded randomized controlled trial is was to evaluate and compare the treatment effects of PowerScope and Forsus in the treatment of Class II division 1 malocclusion. Patient comfort and operator convenience was also assessed and compared .
详细描述
INTRODUCTION : Among different dental and skeletal combinations that can create a Class II malocclusion, mandibular retrusion is one of the most common characteristics.In such cases, to stimulate mandibular growth by forward positioning of the mandible, various removable and fixed functional appliances are commonly used to alter the position of mandible during the pubertal growth period.
Stimulation of mandibular growth, distal movement of upper dentition, mesial movement of lower dentition contributes to correction of Class II malocclusion with the use of fixed functional appliances. Of the various fixed functional appliances available to the orthodontist today for the correction of Class II malocclusion are Forsus fatigue resistant device which is the most popular fixed functional appliance6 and the PowerScope which is a recent addition to the armamentarium.
PowerScope 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. Although there are a few case reports in the literature showing the treatment effects and clinical application of PowerScope, there is not a single study mentioning the effects of PowerScope appliance, which has a different status from other fixed functional appliances due to its special attachment. The purpose of this clinical study was to evaluate the skeletal and dental changes produced by the PowerScope and compare these effects with one of the most commonly used fixed functional appliance the Forsus Fatigue Resistant Device (FRD).
MATERIALS AND METHODS: The present study is a prospective, non-pharmacological, double blind, randomised clinical study conducted in the department of Orthodontics and Dentofacial orthopedics, PGIDS Rohtak.
The study sample consisted of 28 patients, were selected from subjects reporting to the department for fixed orthodontic treatment.
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)
盲法说明
Randomization was done with Simple Randomisation method to ensure 1:1 allocation ratio and allocation concealment was achieved with similar looking sealed opaque envelopes. The name of the groups 'Forsus' and 'PowerScope' were written on 13 pieces of paper resulting in total 26 pieces of paper which were folded and shuffled in a box, then taken out and without opening put in 26 opaque envelopes which were then sealed and kept again in the box. The envelopes were shuffled inside the box each time the patient was asked to pick one envelope from the box .The patient was assigned to the group mentioned in the envelope which was opened by the primary investigator who was not involved in data analysis..
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
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
结局指标
主要结局
changes in mandibular length
时间窗: 12 months
changes in mandibular length after intervention
次要结局
- Evaluation of Operator Convenience(12 months)
- Evaluation of Patient comfort(12 months)