Comparative Study of Bone Implant Contact (BIC) With Experimental Bioecth® Surface Implant Between Native Bone and Regenerated Bone With Autogenous Dentine.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- BIC
研究概览
简要总结
The healing process after tooth removal involves bone remodelling which implies some loss of alveolar bone volume.Among materials proposed for minimising this remodelling and preserving the bone, autologous dental tissue is a promising option, but more data are needed. In this context, the investigator evaluated size and density changes using cone beam computed tomography in autologous dental material (ADM)-preserved sockets compared to controls,and assessed biological responses by histological analysis of bone implant contact (BIC) an Area density (AA) using experimental Bioetch® surface implant.
详细描述
30 patients will be selected for the study, based on the inclusion/exclusion criteria and the clinical judgment of the investigator. Prior to enrollment, all subjects will be asked sign an informed consent form to demonstrate that the patient understand the scope of the study (including surgical interventions and the potential risks involved), allowing the opportunity to ask questions related to the study and giving information about treatments alternatives.
Inclusion criteria:
Partially or totally edentulous patients for whom treatment is indicated. At least 18 years of age, of both sexes and of any race. That the the participants understand that are involved in the study, including the visit requirements of follow-up.
With 6 mm or more bone width, which will be sufficient to place a cylindrical implant with 2 mm Bioetch® surface. in diameter and 8 mm of length. After 16 weeks explantation will be performed for the study, followed by placement of a wider implant.
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Partially or totally edentulous patients for whom treatment is indicated
- •At least 18 years of age, of both sexes and of any race.
- •That they understand that they are involved in the study, including the visit requirements of follow-up.
- •With 6 mm. or more bone width, which will be sufficient to place a cylindrical implant with 2 mm Bioetch® surface. in diameter and 8 mm. of length. After 16 weeks Explantation will be performed for the study, followed by placement of a wider implant.
排除标准
- •Pregnancy.
- •History of uncontrolled systemic disease or chronic diseases.
- •Coagulation disorder or taking anticoagulants.
- •Treatment with bisphosphonates.
- •Subjects with severe compromise of the immune system.
- •History of mental instability that hinders participation in the study.
- •Other conditions that the investigator may feel the patient is not a good candidate for this study (e.g., alcoholism, drug addiction).
结局指标
主要结局
BIC
时间窗: 16 weeks after implant placement
Histomorphometric study of the sample based on the morphology of the surface of the implant. The sample will be evaluated with the MIP-4 program evaluating the percentage of osseointegration (BIC), taking into account the area around the implant.
AA Bone density area
时间窗: 16 weeks after implant placement
evaluation of bone density in 0.25 mm around the experimental implant using the MIP-4 program
次要结局
未报告次要终点
研究者
Hernán López Sacristán
Clinical professor of master bucal surgery, implantology and periodontology
Universidad de León