Radiographic Assessment of Deproteinized Porcine Versus Bovine Bone Mineral in Sinus Augmentation: A Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Apical Bone Height (ABH)
研究概览
简要总结
The goal of this retrospective study is to compare the radiographic outcomes of deproteinized porcine bone mineral (DPBM) and deproteinized bovine bone mineral (DBBM) following lateral sinus floor augmentation (LSFA) with simultaneous implant placement. The main questions it aims to answer are:
Does DPBM show greater graft resorption than DBBM at 6 months postoperatively? Do both materials achieve comparable bone quality and osseointegration outcomes despite differences in resorption rates?
This is a retrospective, single-center cohort study. Participants included 56 patients (56 sinuses) who underwent LSFA with either DPBM (test group, n=28) or DBBM (control group, n=28) and had complete cone-beam CT scans taken preoperatively, immediately postoperatively, and at 6 months post-surgery. Radiographic parameters such as bone height, augmentation volume, and bone texture features were analyzed to evaluate graft stability and new bone formation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80 years;
- •Single or multiple missing teeth in the posterior maxilla with a healing period of at least 3 months;
- •Complete baseline data and surgical records;
- •Underwent LSFA with simultaneous placement of a single implant, grafted exclusively with either DBBM (Bio-Oss®, 0.25-1.0 mm, Geistlich Pharma AG, Wolhusen, Switzerland) or DPBM (THE Graft®, 0.25-1.0 mm, Purgo Biologics, Seoul, Korea);
- •Available CBCT images obtained preoperatively (T0), immediately postoperatively (T1), and at 6 months postoperatively (T2);
- •RBH ≤6 mm shown by CBCT at T0 at the edentulous site;
- •No systemic disease, untreated periapical pathology or active periodontitis;
- •Provision of written informed consent for the implant surgery by the patient or their legal guardian.
排除标准
- •Uncontrolled systemic diseases or any bone-metabolism diseases;
- •Pregnancy or lactation;
- •Head and neck radiation therapy within the past 5 years;
- •acute and chronic inflammation in the maxillary sinus;
- •Additional vertical or horizontal bone augmentation procedures besides LSFA;
- •Use of graft materials other than the specified DBBM or DPBM, or use of composite grafts;
- •Heavy smoking (≥20 cigarettes/day), alcohol abuse, or history of substance abuse;
- •Placement of multiple implants in the same grafted site (excluded to avoid within-patient confounding).
结局指标
主要结局
Apical Bone Height (ABH)
时间窗: immediately postoperatively (T1), and 6 months postoperatively (T2)
The vertical distance (mm) from the implant apex to the most apical point of the graft material
Bone Height (BH)
时间窗: immediately postoperatively (T1), and 6 months postoperatively (T2)
The vertical distance (mm) from the implant shoulder to the most apical point of the graft material. Site-specific measurements were denoted as buccal (bBH), palatal (pBH), mesial (mBH), and distal (dBH) bone heights
Endo-Sinus Bone Gain (ESBG)
时间窗: immediately postoperatively (T1), and 6 months postoperatively (T2)
The vertical distance of the augmented bone along the longitudinal axis of the implant, from the sinus floor to the most apical point of the graft
augmented volume (AV, mm³)
时间窗: immediately postoperatively (T1), and 6 months postoperatively (T2)
The augmented volume (AV, mm³) was measured at both T1 and T2 and was analyzed with the segmentation function of 3D Slicer 5.8.1
次要结局
- Peri-Implant Bone Level (PBL)(immediately postoperatively (T1), and 6 months postoperatively (T2))
研究者
Guoli Yang
Professor
The Dental Hospital of Zhejiang University School of Medicine