Radiographic and Histomorphometric Assessment of Anterior Horizontal Maxillary Bone Augmentation Using Autogenous and Bovine Sticky Bone Versus Autogenous and Bovine Bone Shell Technique (Khoury): A Randomized Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anterior Horizontal Maxillary Alveolar ridge bone gain
研究概览
简要总结
This clinical trial aims to compare two bone augmentation techniques for patients with anterior horizontal maxillary bone defects:
Autogenous and Bovine Sticky Bone Technique using S1 Bovine Bone Graft Autogenous and Bovine Bone Shell Technique (Khoury Technique). The study will evaluate the amount of bone gain and the quality of bone formation after six months using radiographic (CBCT) and histomorphometric analysis. Patients will be randomly assigned to one of the two groups and followed for six months post-surgery to assess bone regeneration, surgical outcomes, and potential complications.
详细描述
This randomized controlled clinical trial will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University. The study addresses the clinical challenge of horizontal maxillary bone defects, which complicate implant placement and require effective augmentation techniques.
Two techniques will be compared:
Autogenous and Bovine Sticky Bone: Using S1 Bovine Bone Graft mixed with autogenous bone chips in a 70:30 ratio.
Autogenous and Bovine Bone Shell Technique (Khoury): Using autogenous cortical bone shells harvested from the mandible combined with S1 Bovine Bone.
The primary outcome is horizontal bone gain assessed by CBCT immediately after surgery and at six months before implant placement. Secondary outcomes include histomorphometric analysis of bone core biopsies to evaluate the quality of bone regeneration.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-55 years.
- •Both males and females.
- •Patients with horizontal bone deficiency in the anterior maxillary region (< 3 mm width) requiring augmentation prior to implant placement.
- •Adequate oral hygiene and commitment to follow-up visits.
排除标准
- •Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- •Heavy smokers (>10 cigarettes/day).
- •Pregnant or lactating women.
- •Previous bone grafting procedures at the same site.
- •Patients on medications affecting bone metabolism (e.g., bisphosphonates).
研究组 & 干预措施
Autogenous + Bovine Sticky Bone
Participants in this group will undergo maxillary horizontal ridge augmentation using a mixture of autogenous bone chips and S1 Bovine Bone Graft in a 70:30 ratio, prepared as Sticky Bone in the area of the defect
干预措施: anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone (Procedure)
Autogenous + Bovine Bone Shell Technique (Khoury)
Participants in this group will undergo horizontal ridge augmentation using autogenous cortical bone plates harvested from the mandibular ramus fixed to the recipient site, with S1 Bovine Bone Graft used to fill the gap between plates and the alveolar bone.
干预措施: anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury) (Procedure)
结局指标
主要结局
Anterior Horizontal Maxillary Alveolar ridge bone gain
时间窗: Baseline (immediately post-surgery) 6 months after augmentation
The primary outcome measure will be the amount of horizontal bone gain at the augmented site measured in millimeters using Cone Beam Computed Tomography (CBCT). Measurements will be taken immediately after augmentation and at 6 months before implant placement.
次要结局
- Quality of bone formation(Up to 6 months)
研究者
Seham Mohammed Ahmed Ahmed Salama
Faculty of Oral & Dental Medicine , Cairo University
Cairo University