Comparison of treatment outcomes of functional appliances versus extraction protocol in Skeletal Class II division 1 malocclusion patients: A prospective clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To evaluate the skeletal, dentoalveolar and soft tissue changes in Class II division 1 patients undergoing maxillary premolar extractions and Forsus Fatigue Resistant device
研究概览
简要总结
This study is a prospective clinical trial conducted at Orthodontics and Dentofacial Orthopedics, Faculty of Dental Sciences, IMS, BHU, Varanasi, India where young adult patients of Class II division 1 malocclusion will be allocated into two groups: Group 1 where upper first premolars will be extracted as a treatment protocol and Group 2 where a Forsus Fatigue Resistant device will be the choice of treatment. The primary outcome is to evaluate the skeletal, dentoalveolar and soft tissue changes in Class II division 1 patients undergoing maxillary premolar extractions and Forsus Fatigue Resistant device. The secondary outcome is to assess the effectivity of Forsus Fatigue-resistant device.
Patients of both the groups will undergo diagnostic evaluation accompanied by study models, radiographs and facial photographs. Pre-adjusted edgewise brackets will be bonded in patients of both the groups. Levelling and alignment will be done using NiTi wires and progressing upto stainless steel wires. First premolar extraction will be done in Group 1 followed by retraction of the anterior segment. In Group 2, Forsus Fatigue Resistant device will be installed till the desired position of mandible is achieved. Pre-treatment and post-treatment lateral cephalogram will be traced and skeletal, dentoalveolar and soft tissue parameters will be drawn, measured and compared within both the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 21.00 Year(s)（—）
- 性别
- All
入选标准
- •Skeletal Class II division 1 malocclusion Angle’s Class II molar relationship Both male and female patients Minimal or no crowding in the mandibular arch and maxillary arch Overjet [7-10mm] No extracted or missing permanent teeth • Post-pubertal phase of skeletal development CVMI (5 and 6) • No medical history or systemic disease that could affect normal growth of the body or jaws • No presence of any craniofacial syndrome • No previous orthodontic treatment.
排除标准
- •Malocclusion other than Class II div 1 malocclusion Previous orthodontic treatment Patients having any Systemic disease or craniofacial syndromes Temporomandibular dysfunction Extracted or missing permanent tooth/teeth Any facial asymmetry • Presence of any parafunctional habits.
结局指标
主要结局
To evaluate the skeletal, dentoalveolar and soft tissue changes in Class II division 1 patients undergoing maxillary premolar extractions and Forsus Fatigue Resistant device
时间窗: At baseline, after 4 months, after 10 months
次要结局
- Effectivity of Forsus Fatigue-Resistant device(After 6 months of installation)
研究者
Dr Vipul Kumar Sharma
Banaras Hindu University