Ridge Preservation With Hardening Calcium Phosphate Bone Substitutes and Resorbable Membrane for Implant Site Development on Non-containable Extraction Sites: A Clinical and Histological Prospective Case Series in Humans
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Radiographic Measurements of Bone Ridge Dimensions
研究概览
简要总结
Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •adequate restorative space for a dental implant restoration, if the subject decides previous to study participation that they would like an implant. Note, agreement to implant placement is not a requirement of the study
- •minimum of 10-mm vertical bone without impinging on adjacent vital structures (Maxillary sinus, neurovascular bundles)
- •single-rooted tooth to be extracted
- •American Society of Anesthesiologists (ASA) Physical Status Classification I or II
- •age >18 years old
- •subjects who had >50% of height on any portion on the buccal wall of dehiscence and/or fenestration of the extraction socket following extraction will be included from this study
- •adjacent teeth to extraction site will be present during healing period
- •willingly sign informed consent and authorization.
排除标准
- •do not meet any inclusion criteria
- •pregnancy or nursing woman
- •subjects with active systemic or localized infection (exclude chronic periodontitis)
- •subjects with a history of any medical conditions that contraindicated or weighed against dental implant placement such as history of bisphosphonate drug use, chemotherapeutic or immunosuppressive agents, autoimmune disease, or poorly controlled diabetes (HBA1c>7%)
- •subjects with smoking habit (more than 10 cigarettes per day)
研究组 & 干预措施
Device treatment
easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
干预措施: easy-graft CLASSIC (beta-Tricalcium Phosphate) (Device)
结局指标
主要结局
Change in Radiographic Measurements of Bone Ridge Dimensions
时间窗: Change from Baseline at 3 months
Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements.
次要结局
- Change in Digital Measurements of Soft Tissue Dimensions(Change from baseline at 5 months)