A Prospective, Observational Clinical Study of the Safety and Effectiveness of the TSV Dental Implant System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Survival rate of implants at 2 years
研究概览
简要总结
This will be a prospective, randomized, observational study. All implants will be placed in either the maxilla or mandible and loaded within 2 months with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.
详细描述
This clinical study will evaluate patients being treated with the Tapered Screw Vent (TSV) dental implant and determine its safety and performance (effect of treatment of edentulism). The patients treated will experience more benefit from treatment of edentulism with the TSV dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years).
Specific objectives include:
- The integration success measured by lack of mobility and resonance frequency assessment
- The measured changes in peri-implant crestal bone levels
- Confirmation of clinical benefits Up to 5 sites will be asked to participate (multicenter study); each site will be selected to place implants (approximately 120 implants across all sites, or 30 implants per site) in patients (any geographic region). The duration of the study will be approximately 2.5 years (last follow up visit is at 2 years) from initiation to completion of data analysis and reporting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients of either sex and at least 18 years of age
- •Patients for whom a decision has already been made to use a dental implant for the restoration of existing edentulism in the mandible and/or maxilla.
- •Prior extracted sites or simultaneous extraction/ implant placement
- •Patients must be physically able to tolerate conventional surgical and restorative procedures.
- •Patients who provide a signed informed consent
- •Patients who agree to be evaluated for each study visit.
排除标准
- •Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
- •Patients who have previously failed dental implants at the site intended for study implant placement
- •Patients with HIV or Hepatitis infection
结局指标
主要结局
Survival rate of implants at 2 years
时间窗: 2 years
The average change in outcome (implant survival) from baseline (time of exposure or implant placement surgery) to the end of study (2 years) will be analyzed (at the implant level).
次要结局
- Crestal bone loss at 2 years(2 years)