Evaluation of Soft-Tissue Changes with Structured Light Scanning after the Course of Twin Block Appliance Therapy- A 3-dimensional Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- 1) To evaluate qualitative changes in soft tissue structure after completion of twin
研究概览
简要总结
This prospective clinical study aims to evaluate qualitative and quantitative changes in facial soft tissues of skeletal Class II Division 1 patients following Twin Block Appliance therapy, using a structured light 3D scanner. Twenty-four patients aged 12–15 years with normal maxilla and retrognathic mandible will be included. Pre- and post-treatment records will consist of clinical examination, cephalograms, and 3D facial scans.
Structured light scanning will be used to capture high-resolution surface data for superimposition and deviation analysis, assessing linear, angular, and volumetric changes in defined facial regions and landmarks. Qualitative assessment will use color map superimpositions, and quantitative analysis will compare deviations across treatment phases. A secondary objective will compare 3D measurements with conventional lateral cephalometric data.
Statistical analysis will employ paired t-tests, ANOVA, or non-parametric equivalents, with significance set at p < 0.05. The study’s outcome is expected to provide precise documentation of soft tissue adaptations, improving understanding of treatment effects and supporting more accurate orthodontic planning for Class II malocclusion cases.
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
- 12.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Skeletal Class II division 1 malocclusion with the normal maxilla and mandibular retrognathia (ANB angle greater than 4°) 2) Dental bilateral (molar and canine) Class II relation and minimal or no crowding in both arches.
- •Increased overjet at or greater than 6 mm.
- •Normal growth pattern or horizontal and have growth potential according to cervical vertebra maturation indicators.
- •(CVMI – Stage III- V).
排除标准
- •History of orthodontic or orthopaedic treatment.
- •Presence of any craniofacial anomaly.
结局指标
主要结局
1) To evaluate qualitative changes in soft tissue structure after completion of twin
时间窗: Evaluate changes 7 months after the twin block appliance therapy
block appliance therapy using superimposed coloured map images.
时间窗: Evaluate changes 7 months after the twin block appliance therapy
2) To evaluate quantitative changes in soft tissue structure after completion of twin
时间窗: Evaluate changes 7 months after the twin block appliance therapy
block appliance therapy using deviation analysis (calculate the deviation in landmarks
时间窗: Evaluate changes 7 months after the twin block appliance therapy
and regions for superimposed facial scan).
时间窗: Evaluate changes 7 months after the twin block appliance therapy
次要结局
- 3)To compare the linear & angular measurements taken on lateral cephalograph vs(3-D soft tissue images.)
研究者
Dr Sejal Naikwadi
Government Dental College , Mumbai