The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- the change in maxilla stability
研究概览
简要总结
The investigator will assess the inverted sequence approach in the treatment of class III patient undergoing bimaxillary orthognathic surgery
详细描述
The investigator will compare the maxillary stability in class III orthognathic patients undergoing bimaxillary surgery by two surgical approaches ; the mandible-first (intervention) and the maxilla-first (control)
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 (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with skeletal class III malocclusion requiring bimaxillary orthognathic surgery
- •Patients free from any systemic disease
- •Patients who approved to be included in the trial and signed the informed consent
- •Patients with no signs or symptoms of temporomandibular disorders.
排除标准
- •Patients with cleft lip and palate "can have an unfavorable effect on facial growth (LARRY M. WOLFORD, 2002)"
- •Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing (JW, 2003) "
- •Patients who refused to be included in the trial
研究组 & 干预措施
maxilla first group
the maxillary osteotomy is going to be done and fixed first
干预措施: the maxilla first (Procedure)
mandible first group
the mandibular osteotomy is going to be done and fixed first
干预措施: the mandible first (Procedure)
结局指标
主要结局
the change in maxilla stability
时间窗: 6 months
to assess the change in maxillary stability on cone beam CT obtained immediately and 6 month postoperative. the measuring unit is millimeter
次要结局
- Patient satisfaction(6 month)
研究者
Mohamed Hamdy
Assistant lecturer
Cairo University