Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles: a Histomorfometric Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of newly formed bone (NB)
研究概览
简要总结
The decrease in maxillary alveolar ridge bone volume and sinus pneumatization are a challenge to implant-assisted prosthetic rehabilitation. Guided bone regeneration using bone substitutes is an adequate alternative for maxillary sinus augmentation. Objective: To histologically and histomorphometrically compare bone repair response to 250 to 1000 µm and 1000 to 2000 µm anorganic bovine bone mineral (ABBM) particles as bone substitute in maxillary sinus augmentation (MSA).
详细描述
Twenty patients were treated with SMA in two steps. They were randomly assigned to one of two groups (n=10): SPG (small particles group) and LPG (large particles group). Different size ABBM particles were implanted in their maxillary sinus, accordingly. A vertical bone core biopsy was obtained at the implant site using a punch trephine. The samples were processed for histological observation and measured histomorphometrically to determine the percentage onewly formed bone (%NB), bone substitute (%BS), bone marrow (%BM), and osseointegration (%OI). Results were statistically analyzed using Student's t test (p ≤ 0.05).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients over the age of 21 years
- •Patients missing teeth in the maxillary sinus region (uni- or bilaterally) with a residual subantral bone height ≤ 4 mm and an alveolar ridge width ≥ 6mm.
- •Patients who had not undergone tooth extraction within 6 months prior to enrollment.
排除标准
- •Patients with diabetes, blood discrasias, a history of head and neck chemotherapy/radiation therapy, acute sinusitis or a history of allergic sinusitis, chronic polypoid sinusitis, or sinus tumors, or a history of Caldwell-Luc surgery
- •Women who were pregnant or of childbearing age
- •Alcoholics and drug abusers
- •Patients requiring MS treatment showing anatomical features of the MS that contraindicated the surgical treatment
- •Patients who refused to sign the informed consent form
- •Patients with a history of chronic periodontitis were treated and then enrolled in the study. Patients who developed post-operative maxillary sinus infection or showed allergic reactions attributable to the grafting material were eliminated from the study.
结局指标
主要结局
Percentage of newly formed bone (NB)
时间窗: 10 month
histomorphometric parameter was assessed in a standardized area
Percentage of bone substitute
时间窗: 10 month
histomorphometric parameter was assessed in a standardized area
Percentage of bone marrow
时间窗: 10 month
histomorphometric parameter was assessed in a standardized area
Percentage of osseointegration
时间窗: 10 month
histomorphometric parameter was assessed in a standardized area, defined as the percentage of graft particle-newly formed bone integration
次要结局
未报告次要终点
研究者
Jorge Ernesto Aguilar
Director and Professor, Oral Implantology Program
Universidad del Salvador, Argentina