NCT05062863已完成不适用
A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Benefits of the T3 Dental Implant System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 139
- 试验地点
- 7
- 主要终点
- Dental implant integration
研究概览
简要总结
This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.
详细描述
This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset.
The main objectives of this study will be:
- The integration success of the dental implant (as measured by mobility)
- The measured changes in peri-implant crestal bone levels for each implant
- Confirmation of clinical benefits
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
- 是
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 active HIV or Hepatitis infection.
结局指标
主要结局
Dental implant integration
时间窗: 2 years
The integration success measured by lack of mobility
次要结局
- Crestal Bone Loss(2 years)
研究者
研究点 (7)
Loading locations...
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