Efficiency of a New Versatile Three-Way Maxillary Expander Versus Modified Fan Expander for Maxillary Arch Expansion in Cleft Lip and Palate Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Maxillary arch development in Anteroposterior dimension
研究概览
简要总结
This randomized controlled trial is designed to compare between Fan expander with palatal springs appliance vs three-way expander regarding the their effectiveness in maxillary expansion in patients with bilateral cleft
详细描述
The study provides three-dimensional expansion for cleft lip and palate patients. Patients with repaired cleft lip and/or palate have maxillary deficiency and hypoplasia in the three planes of space. Most cases have a normal buccolingual occlusal relation in the molar region between upper and lower jaws, while they manifest arch constriction at the anterior inter-canine width area as well as premaxillary collapse and anterior crossbite. Conventional expansion appliances address only the transverse discrepancy requiring a further step to re-align the premaxilla. So, the aim of the study is to compare the efficiency and the effects of the new design of the three-way palatal expander and the modified fan expander in maxillary arch development in cleft lip and palate patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with age ranging from 8 to 15 years old.
- •Patients with bilateral cleft lip and palate.
- •Patients with repaired cleft lip and / or palate.
- •Patients with fully erupted upper permanent 1st molars.
- •Patients in the late mixed or early permanent dentition with tapered maxillary arch, requiring palatal expansion as part of their treatment.
- •Patient's stage of cervical vertebral maturation before or at the growth spurt (CS1-CS4).
排除标准
- •Patients with syndromic cleft lip and palate.
- •Patients with very bad oral hygiene and active periodontal disease.
- •Vulnerable groups
结局指标
主要结局
Maxillary arch development in Anteroposterior dimension
时间窗: [Time Frame: 6 - 12 months]
Anterior expansion of the premaxilla in the sagittal plane measured through lateral Cephalograms
Maxillary arch development in Anteroposterior dimension
时间窗: [Time Frame: 6 - 12 months]
Anterior expansion of the premaxilla in the sagittal plane measured through lateral Cephalograms
次要结局
- Inter-canine width expansion in the transverse plane([Time Frame: 6- 12 months])
- Dental changes with expansion([Time Frame: 6- 12 months])
- Inter-canine width expansion in the transverse plane([Time Frame: 6- 12 months])
- Dental changes with expansion([Time Frame: 6- 12 months])