External Distraction Using Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla in Non-growing Cleft Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Distraction effectiveness
研究概览
简要总结
Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue & better long-term stability & less relapse rate.
详细描述
Maxillary distraction using rigid external distraction device (RED) with skeletal anchorage in cleft lip and palate overcomes the disadvantages of tooth brone RED & showed reliable advancement & reasonable relapse rate in the short & long-term follow up & most importantly it solved somehow counterclockwise rotation of maxilla but still it can occur. Positioning of plates in relation to center of resistance of maxilla to adjust vector of distraction can be done now by using Virtual surgical planning (VSP) & fabrication of patient specific implants (PSI) to overcome problems encountered with use of conventional miniplates during distraction process. Limited data in literature with no randomized clinical trials were done to assess distraction effectiveness using PSI in RED with skeletal anchorage and its effect on velopharyngeal insufficiency (VPI) & speech. Based on that data, the research will compare distraction effectiveness, VPI & speech between using either PSI implants or miniplates for distraction.
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)
盲法说明
single blinded clinical trial
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non growing cleft patients, age range (18-30 years)
- •Unilateral or bilateral cleft patients
- •Anteroposterior deficiency (1.5-2.5 cm)
- •No sex predilection
排除标准
- •Syndromic patients.
- •bone metabolism & systemic diseases.
结局指标
主要结局
Distraction effectiveness
时间窗: immediate postoperative, 4 months postoperatively, 10 months postoperatively
Amount of distraction using Lateral Cephalometry \& FBCT measured in millimeters (mm)
次要结局
- Nerve affection(immediate postoperative till 4 months postoperatively)
- Screw loosening(immediate postoperative till 4 months postoperatively)
- Operative time(Immediate postoperative)
- Overall complications(immediate postoperative, 4 months postoperatively and 10 months postoperatively)
- Velopharyngeal insufficiency(Preoperative , 4 months postoperatively, 10 months postoperatively)
- Speech(preoperative, 4 months postoperatively, and 10 months postoperatively)
- Wound dehiscence(immediate postoperative till 4 months postoperatively)
- Infection(immediate postoperative till 4 months postoperatively)
研究者
Hagar Mahmoud Ahmed Mohamed
Principal investigator, Phd candidate, Department of Oral & Maxillofacial Surgery, Faculty of Dentistry
Cairo University