The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Dentoskeletal and soft tissue changes
研究概览
简要总结
A randomized clinical trial to introduce a modified 3D printed customized maxillary protraction facemask and evaluate its efficacy in comparison with the conventional maxillary protraction facemask therapy in correction of Class III malocclusion of young patients
详细描述
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional facemask appliance will be used while group two, the modified facemask appliances. Lateral cephalometric x-ray, Study models, photographs, and patient questionnaire will be taken before starting the treatment (T0) and at the end of treatment (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after 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
- Single (Outcomes Assessor)
盲法说明
Blinding to treatment allocation is possible only for the outcomes assessor because the clinicians know the intervention. The trial documents will be labeled with ID number, which be used for participant identification and data collection without unmasking the allocation group
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Skeletal and dental relationships: skeletal class III with retrognathic maxilla and normal mandible with overjet < 0 mm.
- •Concave profile with normal lower facial height (clinically and radiographically).
- •Good oral health free from caries and periodontal problems at the start of treatment.
排除标准
- •Previous history of orthopedic and/or orthodontic treatment.
- •Patients with vertical growth pattern or backward mandibular rotation tendency.
- •Patients with gross facial asymmetry.
- •Patients with cleft lip and palate and/or craniofacial syndrome
- •Patients with bad oral habit.
- •Active periodontal disease.
- •Previous history of TMJ signs or symptoms
结局指标
主要结局
Dentoskeletal and soft tissue changes
时间窗: (T0) before starting the treatment and (T1) after 9 months of treatments.
Cephalometric analysis will be perfomed by measured different skeletal and soft tissue points in degrees at two time (T) intervals, (T0) before starting the treatment and (T1) at 9 months after treatment.
次要结局
- Skeletal and soft tissue changes((T0) before starting the treatment and (T1) after 9 months of treatments.)
- Dental changes((T0) before starting any treatment and (T1) after 9 months of treatments)
研究者
Mushriq F. Abid
Professor
University of Baghdad