The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation: A Clinical, Radiographic, and Histomorphometric Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical alveolar ridge dimension changes
研究概览
简要总结
This study will examine whether the use of synthetic carbon apatite bone graft material will lead to more bone formation compared to human derived allograft and bovine derived xenograft material.
详细描述
Bone grafts are commonly placed to increase the amount of bone right after tooth extraction and prepare the site for future dental implant placement.
45 patients requiring a tooth extraction will be recruited and randomized to receive either allograft, xenograft, or synthetic bone grafting.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 80 years old
- •Patients requiring tooth extraction (incisors, canines, and premolars) due to caries, periodontal disease, tooth fracture, or unrestorable condition.
- •Extraction sockets must be infection-free with dehiscence less than 5mm.
- •Patients interested in implant placement after tooth extraction.
排除标准
- •Known allergies or hypersensitivities to medications related to the study (e.g., chlorhexidine)
- •Hematologic disorders or blood dyscrasias.
- •Active infectious diseases.
- •Liver or kidney dysfunction/failure.
- •Uncontrolled diabetes (i.e., HbA1c > 8).
- •Undergoing active cancer treatment, including chemotherapy or radiotherapy within the last 12 months from the procedure.
- •Use of medications affecting bone healing (e.g., bisphosphonates, long-term anti-inflammatory medications).
- •Metabolic bone diseases affecting bone healing, such as osteoporosis (self-reported).
- •Pregnant or lactating women (self-reported).
- •Current smokers of 10 or more cigarettes per day and former smokers who quit less than 10 years ago (self-reported).
- •Poor oral hygiene.
- •Presence of fenestration defects equal to or greater than 5mm.
结局指标
主要结局
Clinical alveolar ridge dimension changes
时间窗: 4 months
Clinically measured alveolar ridge dimension changes in mm
次要结局
- Histological bone density(4 months)
- Presence of bone turnover proteins(4 months)
- Alveolar volumetric changes following tooth extraction(4 months)
研究者
Hom-Lay Wang, DDS, MSD, Ph D
Collegiate Professor of Periodontics and Professor of Dentistry, Department of Periodontics and Oral Medicine, School of Dentistry
University of Michigan