Evaluation of the skeletal, dental & soft tissue changes with intermaxillary elastics combined with anterior bite turbos for the correction of skeletal Class II malocclusion: A pilot study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Correction of skeletal Class II malocclusion
研究概览
简要总结
Subjects found suitable in the above inclusion criteria for the study shall be explained the scope of the study and written consent shall be obtained. Pre-treatment records (T1) in the form of photographs (extraoral & intraoral), radiographs i.e., OPG, Lateral cephalogram, and study models formaxillary and mandibular arch shall be recorded.
The patients will undergo the fixed mechanotherapy with 0.022″ MBT PEA which will be started simultaneously with functional jaw orthopedics. Two micro-implants will be inserted (one on either side of the maxillary arch distal to maxillary canines), along with customized anterior bite turbos made with a mini mold kit bonded on upper incisors. Intermaxillary elastics will be used from lower molar hooks to the implants inserted in the maxillary arch. The intermaxillary elastics will aid in the forward positioning of the mandibular arch duly assisted by the anterior bite turbos. In addition, the bite turbos will further aid in opening the deep bite.
Post-functional records (T2) in the form of photographs (extraoral & intraoral), radiographs i.e., OPG, Lateral cephalogram, and dental models formaxillary and mandibular arch shall be obtained after completion of Functional phase of the treatment. The treatment effects at T1 and T2 will be evaluated and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 11.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Class II Div 1 malocclusion with ANB more than 4 degrees
- •Bilateral Class II or Half Cusp Class II molar relation
- •Patients with cephalometric features of orthognathic maxilla and retro gnathic mandible
- •Positive visual treatment objective
- •CVMI stage III or IV
- •Patients giving written consent to participate in the study.
排除标准
- •Class II Div 2 Malocclusion
- •History of orthodontic treatment
- •Systemic diseases affecting bone metabolism
- •Patients with neuromuscular disorder & TMJ problems
- •Presence of any craniofacial anomalies or pathologies.
结局指标
主要结局
Correction of skeletal Class II malocclusion
时间窗: After completion of functional phase (Approximately 06 months)
次要结局
- To evaluate the total treatment duration & frequency of appliance breakages.(After completion of functional phase in approximately 06 months)
研究者
Saugat Ray
AFMC (Armed Forces Medical College)