Prospective, Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials (SYMBIOS CORTICAL-CANCELLOUS GRANULE MIX; SYMBIOS OSTEOGRAF LD-300; OSTEOGRAF/N-300) Following Tooth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Total Mean Change in Bone Volume
研究概览
简要总结
This study is intended to provide statistically robust evidence that Symbios Demineralized Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. Additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. It is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •≥ 18 years and ≤ 75 years
- •Good physical health (ASAI/II)
- •Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
- •Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (> 3 mm) and/or significant soft tissue deficiencies
排除标准
- •Buccal plate dehiscence and/or fenestration >3mm at study site following extraction
- •Untreated rampant caries and uncontrolled periodontal disease
- •Inadequate oral hygiene (estimated plaque score >20%)
- •Smokers using more than 10 cigarettes or equivalent per day
- •Smokeless tobacco use or e-cigarette use
- •Compromised physical health and/or uncontrolled or severe systemic diseases including:
- •ASA III/IV Metabolic bone disease History of malignancy History or radiotherapy or chemotherapy for malignancy in the past 5 years History of autoimmune disease Long-term steroidal or antibiotic therapy Uncontrolled diabetes Known alcohol or drug abuse
- •Systemic or local disease or condition that would compromise post-operative healing
- •Use of any substance or medication that will influence bone metabolism
- •Known pregnancy
- •Unable or unwilling to return for follow-up visits for a period of 6 months
- •Unlikely to be able to comply with study procedures according to Investigators judgement
- •Involvement in the planning and conduct of the study
- •Previous enrollment or randomization of treatment in the present study
结局指标
主要结局
Total Mean Change in Bone Volume
时间窗: time of extraction to 3 months post extraction
The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software
次要结局
- Mean Soft Tissue Dimensional Changes-Vertical(time of extraction to 3 months post extraction)
- Mean Osseous Dimensional Changes-Vertical(time of extraction to 3 months post extraction)
- Mean Osseous Dimensional Changes-Horizontal(time of extraction to 3 months post extraction)
- Total Mean Change in Soft Tissue Volume(time of extraction to 3 months post extraction)
- Mean Soft Tissue Dimensional Changes-Horizontal(time of extraction to 3 months post extraction)
- Soft Tissue Dimensional Change at Month 6(Month 6)