Dentoskeletal Effects of CAD/CAM 3D-Printed Fixed Twin Block Versus MARA Appliances in the Management of Skeletal Class II Due to Mandibular Deficiency in Preadolescence: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Linear Skeletal changes of the maxilla and mandible using cephalometric measurements
研究概览
简要总结
Objective: to evaluate the dentoskeletal effects of CAD/CAM 3D-Printed fixed twin block versus MARA appliances in the management of skeletal class II due to Mandibular Deficiency in Preadolescence Class II malocclusion is considered one of the most commonly observed problems among orthodontic patients, representing around one-third of the patients seeking orthodontic treatment reflecting a significant economic impact. Various removable and fixed functional appliances are commonly used to stimulate mandibular growth. Fixed Twin-block appliance has advantages compared with removable Twin-block and Herbst appliances. The mandibular anterior repositioning appliance is referred to as M.A.R.A. appliance.
Materials and method: The study design is a randomized controlled trial in which the control group and intervention groups will be assessed as parallel groups with a 1:1:1 allocation ratio. Sixty subjects will be enrolled in this research. They will be divided equally into three groups: untreated control, MARA group and Twin block group
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
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletal Class II malocclusion due to mandibular retrusion.
- •Overjet ≥ 6.0 mm.
- •Normal or low-angle growth pattern.
- •Minimum crowding in the mandibular arch.
- •Undergoing circumpubertal phase of skeletal development (CVMI 2, 3, and 4)
排除标准
- •Clinical signs and symptoms of temporomandibular disorder.
- •Systemic disease affecting bone and general growth.
- •Previous orthodontic treatment
- •Cleft lip or palate.
- •Congenital craniofacial deformity.
- •Abnormal oral habits.
研究组 & 干预措施
. MARA group, who will undergo MARA appliance
干预措施: MARA appliance (Device)
Control group, who will be the untreated group.
Fixed twin block group, who will undergo fixed twin block appliance
干预措施: fixed twin block (Device)
结局指标
主要结局
Linear Skeletal changes of the maxilla and mandible using cephalometric measurements
时间窗: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
linear (mm) measurement
Angular skeletal changes of the maxilla and mandible using cephalometric measurements
时间窗: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
angular (°) measurement
Linear dental changes of the maxilla and mandible using cephalometric measurements
时间窗: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
linear (mm) measurement
Angular dental changes of the maxilla and mandible using cephalometric measurements
时间窗: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
angular (°) measurement
Linear soft tissue changes of the maxilla and mandible using cephalometric measurements
时间窗: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
linear (mm) measurement
Angular soft tissue changes of the maxilla and mandible using cephalometric measurements
时间窗: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
angular (°) measurement
次要结局
- Oral health quality of life questionnaire(From date of randomization until the date of first documented acceptable correction assessed up to 6 months)
- Incidence of breakages and harms reported during routine or emergency visits in both groups(From date of randomization until the date of first documented acceptable correction assessed up to 6 months)
- Arch perimeter and depth measurement from digital model analysis(From date of randomization until the date of first documented acceptable correction assessed up to 6 months)
- Maxillary inter-canine width from digital model analysis(From date of randomization until the date of first documented acceptable correction assessed up to 6 months)
- Maxillary inter-first molar width from digital model analysis(From date of randomization until the date of first documented acceptable correction assessed up to 6 months)
研究者
Yasmin Ghaly
Assistant Lecturer
Mansoura University