Evaluation of Mineralized Plasmatic Matrix Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized, Triple Blinded, Parallel Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 56
- 主要终点
- Oro-nasal Fistula
研究概览
简要总结
The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate bone volume and acceptable density at the site of grafting.MPM might improve the physiological properties of allogenic bone graft and facilitate its handling and application during surgical grafting.This might decrease the need of the second surgical site for harvesting autogenous bone to be grafted with its all complications and hurdles.This trial will help the practitioners in taking the decision of using the MPM prepared from allogenic bone in alveolar cleft closure or not.
详细描述
Alveolar bone grafting will be performed at 6 to 12 years of age as following :
Group (A):Will undergo grafting with anterior iliac crest bone,(Control group). Group (B):Will undergo grafting with Mineralized Plasmatic Matrix prepared from allogenic bone graft (study group).
In all patients, this will be the first bone graft to be placed in the alveolar cleft. All patients will be monitored clinically and radiographically (by cone beam C.T) for up to 6 months after surgery.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral or bilateral alveolar cleft patients
排除标准
- •patients with previous failed alveolar cleft grafting procedure.
研究组 & 干预措施
MPM prepared from allogenic bone graft
All patients in this group will receive MPM prepared from allogenic bone graft
干预措施: MPM Prepared From Allogenic Bone Graft (Combination Product)
Autogenous bone graft group
All patients in this group will receive autogenous bone graft only
干预措施: Autogenous bone (Other)
结局指标
主要结局
Oro-nasal Fistula
时间窗: 6 months
it will be assessed visually and by questionnaire with binary measuring unit (present or not).• Examination of oro-nasal Fistula will be done by using the following diagnostic criteria: 1.Air escape from the opening when patient blows his/her nose. 2.An obvious communication between the opening and floor of the nasal cavity. 3.Unobstructed penetration of Guttapercha through the opening into the nasal cavity. 4.Hypernasality of voice due to audible nasal air escape during speech. 5.Nasal regurgitation of fluids. 6.Food lodgement into nasal cavity with risk of rhinitis .
次要结局
- C.T analysis of secondary bone grafts(6 months)
- Donor site long standing pain(6 months)
研究者
Mohamed Salah
principal investigator
Cairo University