Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.
研究概览
简要总结
- Hard tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
- Soft tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
Participants will undergo orthodontic treatment, including:
- Initial records (intraoral scan, CBCT (cone-beam computed tomography) scan, face scan)
- Placement of guided orthodontic TADs (Temporary Anchorage Devices)
- Skeletal expansion using CAD/CAM appliance
- Fixed multibracket appliance in the upper and lower jaw
- Intermediate and terminal documents (intraoral scan, CBCT scan, face scan)
详细描述
This clinical trial aims to evaluate the influence of maxillary expansion using a CAD/CAM-manufactured appliance impact on the soft and hard tissues in the midfacial region in adolescent and adult orthodontic patients.
This study aims to evaluate how this treatment changes the bony structures and soft tissues (for example, the nose) in the mid-facial region during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
The appliance consists of two anchorage elements on the first molars and two TADs. The mini-screws are placed on the palate under local anesthesia with the help of drilling templates.
CAD/CAD milled and 3D printed guides will be used for the placement of the TADs.
The study will be conducted on orthodontic patients between 12 and 26 years who will receive fixed orthodontic braces in the upper and lower jaw and show a width deficit of the upper jaw.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maxillary transverse deficit,
- •Lateral crossbite
排除标准
- •Previous orthodontic treatment,
- •Craniofacial anomalies,
- •Severe facial asymmetries,
- •Pregnancy,
- •Periodontal lesions
结局指标
主要结局
Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.
时间窗: up to six months
Comparison of midfacial landmark changes during maxillary expansion
次要结局
- CAD/CAM milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position.(up to 4 weeks)
研究者
Alexander Schwaerzler, DMD
Principal Investigator
Medical University of Vienna