Clinical and Radiographic Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique: A Preliminary Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Bone density immediate versus 6 months postoperatively.
研究概览
简要总结
The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.
详细描述
In conventional cleft grafting technique, there is always risk for grafted bone resorption and recurrence of fistula formation. So alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments will work more efficient and prevent the fore mentioned risk of graft resorption and recurrence of fistula.
In conventional cleft grafting techniques, most of the cases reported in literature raised a debate regarding the final gained amount of bone, with subsequent recurrence of oronasal fistula. In this study, alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments and the conventional grafting technique will be compared to evaluate which technique will offer better reconstruction of the alveolar ridge with maintained bone width and height.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old).
- •repaired cleft lip.
- •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 unilateral maxillary alveolar cleft.
- •Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft
- •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.
- •Active infection or severe inflammation in the area intended for graft placement
- •Unable to open mouth sufficiently to accommodate the surgical tooling.
- •Patients participating in other studies, if the present protocol could not be properly followed.
- •Unable to attend a 9-month follow-up.
结局指标
主要结局
Bone density immediate versus 6 months postoperatively.
时间窗: 6 months
bone density changes are measured using CBCT after 6 months via HU
次要结局
- Bone width and height immediate versus 6 months postoperatively(6 months)
研究者
Maha Ahmed Ibrahim Ahmed
Resident at oral and maxillofacial surgery department
Cairo University