Prospective, Comparative Assessment of Alveolar Ridge Preservation Using GUIDOR® Easy-graft® Classic in Atraumatic Extraction Socket
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)
研究概览
简要总结
Randomized Controlled study to compare the effectiveness of two different treatment approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge preservation of an atraumatic extraction socket site compared to allograft with collagen plug.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •At least 18 years old
- •In need of one posterior tooth, excluding third molar molars, planned for extraction and replacement with a dental implant (If the subject requires two adjacent socket preservation, they can still be enrolled in the study but only one site will be used for the study)
- •Intact ridge as verified with cone-beam CT scan
- •At least one natural tooth adjacent to the study site present.
排除标准
- •Insufficient interocclusal space to allow for implant supported prosthesis
- •Dehiscence or fenestration identified at the time of reviewing CBCT.
- •Non-treated caries or uncontrolled periodontal disease present affecting the teeth in adjacent to study teeth.
- •Any of natural teeth adjacent to the study site presents active periapical endodontic lesion ("active periapical endodontic lesion" will be determined per consultation by endodontics specialist).
- •Adjacent tooth (mesial and distal) to study site was extracted within last 6 months
- •Adjacent teeth (or tooth) to study site with significant soft tissue loss
- •Smoker using more than 10 cigarettes or equivalent per day
- •Smokeless tobacco use or e-cigarette use
- •Current alcohol or drug abuser
- •Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration e.g. uncontrolled diabetes
- •Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
- •Pregnancy, as indicated by positive serum human chorionic gonadotropin (HCG) test result.
- •Unable or unwilling to return for follow-up visits for a period of 5 months
- •Unlikely to be able to comply with study procedures according to Investigators judgement
- •Subject in other clinical trials
结局指标
主要结局
Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)
时间窗: Baseline and 4 months post-surgery
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Linear measurement of horizontal ridge width is measured at 1 mm apical to the crest. Change of horizontal ridge width = (Baseline measurement - 4 months measurement)
Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)
时间窗: Baseline and 4 months post-surgery
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Bone volume measurement is expressed in mm3, which allowed for a calculation of the % of volumetric reduction that took place from baseline to 4 months post-surgery.
次要结局
- Histomorphometric Assessment of Newly Formed Mineralized Tissue(5 months post-surgery)
- Histomorphometric Assessment of Non-mineralized Tissue(5 months post-surgery)
- Change of Marginal Bone Level Around Dental Implant(Baseline, 6, and 12 months after crown delivery)
- Histomorphometric Assessment of Residual Bone Graft Particles(5 months post-surgery)