Evaluation of the Efficiency of Bone Born Intra Oral Distractor for Closure of Wide Alveolar Cleft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in alveolar cleft defect area measured by cone-beam computed tomography (CBCT) (minimum value: 0 mm²; no predefined maximum value; lower values indicate better outcome)
研究概览
简要总结
The study aimed to determine efficiency of Bone-Born Intraoral Distractor on wide Alveolar cleft patients
详细描述
Stereographic models were used for construction of bone-born custom-made intraoral distractor according to the inclusion and exclusion criteria, followed up to measure and determine the efficiency of the distractor
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This wasn't applicable during surgery and follow-up
入排标准
- 年龄范围
- 7 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with wide alveolar clefts more than 8ml either unilateral or bilateral or median facial cleft.
- •Patients who had previous failed grafting also may be included.
- •Age range of patients 7-20 years old, with no gender prediction, able to read and sign the informed consent (parents)
- •Patients with median facial clefts.
排除标准
- •Narrow alveolar cleft
- •Syndromic patients.
- •Oral soft tissues defects, inflammation, infections and bone metabolism disturbance.
- •Allergy to titanium implant.
- •Patient with systemic disease and immunocompromised patient.
研究组 & 干预措施
Bone-Borne Intra-oral distractor
Surgeries to fix the device were conducted under GA. Then latency period of seven days was applied. Activation was 0.5 mm twice a day. The transport segment touched the docking site then the Consolidation period is achieved. Follow up for 6 months.
干预措施: Bone-borne Intra oral distractor (Device)
结局指标
主要结局
Change in alveolar cleft defect area measured by cone-beam computed tomography (CBCT) (minimum value: 0 mm²; no predefined maximum value; lower values indicate better outcome)
时间窗: 6 months postoperative follow up
The alveolar cleft defect area will be quantitatively measured using cone-beam computed tomography (CBCT). Preoperative and postoperative CBCT scans will be superimposed to calculate the change in defect area following distraction osteogenesis.
Change in tooth mobility assessed using Miller's Tooth Mobility Index (minimum score: 0; maximum score: 3; higher scores indicate worse mobility)
时间窗: 6 months postoperative follow up
Tooth mobility will be clinically evaluated using Miller's Tooth Mobility Index to detect and grade the degree of mobility before and after treatment.
Vitality of the transported bone segment assessed by clinical vitality indicators after transport distraction osteogenesis (binary outcome: viable / non-viable; viable outcome indicates better result)
时间窗: 6 months follow up
Vitality of the transported disk after transport distraction osteogenesis is measured through clinical indicators as No infection, No pain or inflammation, Stable transported segment, Successful consolidation phase.
次要结局
未报告次要终点
研究者
Hanaa Elmorsy
Assistant Lecturer at Oral and Maxillofacial Surgery department at AlAzhar University
Faculty of Dental Medicine for Girls