Alveolar Cleft Reconstruction Using Double Iliac Corticocancellous Bone Blocks Technique Versus Particulate Autogenous Spongy Bone Graft From Anterior Iliac Crest. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Measuring graft height in millimeters
研究概览
简要总结
Reconstruction of Alveolar Cleft Using Double Iliac Corticocancellous Blocks in comparison with the gold standard technique ( cancellous bone ) both from anterior iliac crest.
详细描述
This study will compare two techniques for the proper alveolar cleft reconstruction with adequate bone bridge formation of maximum bone quality, contour, and minimal resorption. One of them is packing autogenous particulate spongy bone from the anterior iliac crest (gold standard). While the other technique would be reconstruction of the cleft with two iliac corticocancellous bone blocks with cancellous bone in between. which benefits of the rapid revascularization and healing of cancellous bone and the strong mechanical properties of cortical bone that will aid in obtaining a proper reconstruction and form for the defect and can be applied to defects of any size.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with complete maxillary alveolar cleft either unilateral or bilateral at the age of mixed dentition (between 7 and 13 years old).
- •repaired cleft lip.
- •Patients with cleft lip and palate who have not undergone alveolar grafting procedure.
- •Patients with unerupted maxillary permanent canine in the cleft region.
- •Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
- •Both genders males and females will be included
排除标准
- •General contraindications to surgical intervention of the area. Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft.
- •Patients with associated syndrome.
- •Patients requiring concomitant Orthognathic surgical procedure.
- •Subjected to irradiation in the head and neck area less than 1 year before surgery.
- •Untreated periodontitis.
- •Poor oral hygiene.
- •Uncontrolled diabetes.
- •Immunosuppressed or immunocompromised.
- •Treated or under treatment with intravenous amino-bisphosphonates.
- •Active infection or severe inflammation in the area intended for graft placement.
- •Patients participating in other studies, if the present protocol could not be properly followed.
结局指标
主要结局
Measuring graft height in millimeters
时间窗: 9 months
CBCT scan analysis for measuring mean graft height in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft height in millimeters after 9 months of every graft for assessment of grafts height stability of both groups over 9 months.
Measuring graft width in millimeters
时间窗: 9 months
CBCT scan analysis for measuring mean graft width in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft width in millimeters after 9 months of every graft for assessment of grafts width stability of both groups over 9 months.
次要结局
- Measuring graft volume in cubic millimeter(9 months)
研究者
Louai Ahmed Rafat Mohammed
Principal Investigator
Cairo University