Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients (A Randomized Controlled Clinical Trail)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurement of linear skeletal change
研究概览
简要总结
This study aims to evaluate the dento-alveolar changes after maxillary expansion in cleft lip and palate patients by Leaf Self Expander, as compared to conventional Rapid Maxillary Expander using digital cast analysis and three-dimensional cone-beam computed tomography.
详细描述
Orofacial clefts are the most prevalent among congenital malformations, which can involve the upper lip, alveolar ridge or/and the palate and, in general, cause esthetic, functional, and psychosocial impairments in different magnitudes, depending on its location and extension.
The Leaf Self Expander (LSE) is a new technology that similar to LE in design except absence of the reactivation screw and respects the principle of producing predetermined light, constant forces, without any intervention by the patient, parents or orthodontist. Where it is composed of three leaf springs compressed by the laboratory before delivery, it is deactivated spontaneously until the programmed expansion is achieved.
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
- None
入排标准
- 年龄范围
- 3 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral or bilateral cleft lip and palate in mixed dentition.
- •Lip and palate repair was performed from 3 to 24 months of age.
- •Presence of maxillary constriction and need of maxillary expansion prior to secondary alveolar bone grafting.
- •Good periodontal health.
排除标准
- •Previous orthodontic treatments.
- •Any systemic diseases.
- •Multiple carious lesions.
研究组 & 干预措施
Group A (Control group)
Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion.
Patients were treated with Leaf Self Expander for maxillary expansion.
干预措施: Rapid maxillary expansion (Other)
Group B (Tested group)
Patients were treated with Leaf Self Expander for maxillary expansion.
干预措施: Leaf Self Expander (Other)
结局指标
主要结局
Measurement of linear skeletal change
时间窗: 6 months post-expansion
Linear skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.
次要结局
- Measurement of angular skeletal change(6 months post-expansion)
- Measurement of linear dental change(6 months post-expansion)
- Measurement of angular dental change(6 months post-expansion)
研究者
Tasneem Ahmed Almohamady Khalil
Assistant lecturer, Orthodontic Department, Faculty of Oral and Dental Medicine, MUST University.
Al-Azhar University