Radiographic and Histomorphometric Assessment for Guided Bone Regeneration Using a Mixture of Autogenous and Xenograft Particulate Versus Patient-Specific Sticky Bone for Horizontal Anterior Maxillary Defect (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiographic and Histomorphometric Assessment for Guided Bone Regeneration using a Mixture of Autogenous and Xenograft Particulate Versus Patient-Specific Sticky Bone for Horizontal Anterior Maxillary Defect (Randomized Clinical Trial)
研究概览
简要总结
This study aims to enhance healing while minimizing invasiveness and restoring tissues to their proper structure and function by using patient specific sticky bone that will enhance the soft tissue reaction and maintain the graft volume stability and bone quality which stabilizes bone grafts, accelerates tissue healing, and reduces bone loss.
详细描述
II. Introduction:
6.Background and rationale:
Research question:
Does changing the bone consistency using patient specific sticky bone will enhance the soft tissue reaction and maintain the graft volume stability and bone quality if compared to the standard mix of autograft and xenograft for horizontal augmentation of anterior maxilla using guided bone regeneration? PICO Population (P): Patients with horizontal anterior maxillary defect. Intervention (I): Specific bone putty with mixture of autogenous and xenograft Comparator (C): Guided bone regeneration using mixture of autogenous and xenograft
Outcome (O):
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders requiring implants placement in anterior maxilla with horizontal bone defect.
- •Patients of age older than 20 years old.
- •Patients with adequate Inter-arch space.
- •Patients who were willing and fully capable to comply with the study protocol.
排除标准
- •Heavy smokers (> than 10 cigarettes a day)
- •Patients with parafunctional habits
- •Patients with uncontrolled systemic diseases.
- •Patients with poor oral hygiene
- •Patients with mental instabilities or psychic patient
研究组 & 干预措施
Autogenous + Xenograft particulate group.
干预措施: Mixture of Autogenous and Xenograft Particulates (Procedure)
Patient-specific Sticky Bone group.
干预措施: Patient-Specific Sticky Bone (Procedure)
结局指标
主要结局
Radiographic and Histomorphometric Assessment for Guided Bone Regeneration using a Mixture of Autogenous and Xenograft Particulate Versus Patient-Specific Sticky Bone for Horizontal Anterior Maxillary Defect (Randomized Clinical Trial)
时间窗: Baseline (preoperative), 6 months postoperative for radiographic evaluation; 6 months postoperative for histomorphometric biopsy assessment at re-entry.
Radiographic outcomes will include CBCT-based measurements of horizontal ridge width and bone volume gain at the grafted sites. Histomorphometric evaluation will be performed using biopsies collected at re-entry to assess new bone formation, residual graft particles, and connective tissue. Comparisons will be made between autogenous/xenograft particulate grafts and patient-specific sticky bone in terms of bone regeneration effectiveness.
次要结局
未报告次要终点
研究者
Mohamed Mohsen Mohamed Nasr
DR Mohamed Mohsen Mohamed Nasr
Cairo University