Clinical, Radiographic and Histologic Assessment of the Efficacy of Bioactive Glass as a Novel Grafting Material in Maxillary Sinus Floor Augmentation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Change in vertical bone height measured by CBCT
研究概览
简要总结
This randomized controlled study aims to evaluate the clinical, radiographic, and histologic efficacy of using bioactive glass bone graft (UNIGRAFT by Biomed Inc., USA) compared to a conventional xenograft in maxillary sinus augmentation procedures. A total of 20 patients classified as SA4 according to the Misch classification will be enrolled and randomly allocated into two groups. Outcomes will be assessed using Cone Beam Computed Tomography (CBCT) for vertical bone gain and, where applicable, histologic analysis. The study is conducted at the Faculty of Dentistry, Suez Canal University.
详细描述
The aim of this clinical study is to compare the performance of a novel bioactive glass bone graft (UNIGRAFT) with a standard xenograft material in open sinus lift procedures for patients with severely atrophic maxillary posterior ridges (Misch SA4 classification). The trial is designed as a parallel-arm, randomized controlled study involving 20 patients. Each participant will undergo maxillary sinus augmentation using either the bioactive glass or the xenograft, followed by a healing period prior to implant placement.
Radiographic evaluation using CBCT will be conducted to assess vertical bone height gain pre- and post-operatively. Additionally, histological samples may be obtained during implant placement in indicated cases to evaluate bone quality. The primary endpoint is vertical bone gain after 6 months, and secondary endpoints include bone density, complication rate, and histologic characteristics. The study will follow strict ethical guidelines and is approved by the institutional ethics committee of Suez Canal University.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring maxillary sinus floor augmentation for dental implant placement.
- •Residual alveolar bone height ≤ 4 mm in posterior maxilla (SA4 classification).
- •Age between 20 to 65 years.
- •Good general health and able to attend scheduled follow-up visits.
- •Signed written informed consent.
排除标准
- •Presence of systemic conditions that could affect bone healing (e.g., uncontrolled diabetes, osteoporosis).
- •History of radiotherapy in the head and neck region.
- •Heavy smoking (more than 10 cigarettes/day).
- •Active sinus pathology or previous sinus surgery.
- •Pregnant or breastfeeding women.
- •Use of medications affecting bone metabolism (e.g., bisphosphonates or corticosteroids).
- •Poor oral hygiene or untreated periodontal disease.
研究组 & 干预措施
Bioactive Glass Group
Patients in this group will undergo maxillary sinus floor augmentation using bioactive glass bone graft material (UNIGRAFT, Biomed Inc., USA). The procedure will be performed via open sinus lift approach.
干预措施: Bioactive Glass Bone Graft (UNIGRAFT) (Device)
Xenograft Group
Patients in this group will undergo maxillary sinus floor augmentation using a conventional xenograft material via open sinus lift approach.
干预措施: Xenograft Bone Graft (Bio-Oss) (Device)
结局指标
主要结局
Change in vertical bone height measured by CBCT
时间窗: 6 months after sinus augmentation
Evaluation of the change in vertical bone height in the grafted sinus area using CBCT imaging. CBCT scans will be taken preoperatively and at 6 months postoperatively to assess bone formation
次要结局
未报告次要终点