A Prospective, Randomized, Comparative Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3 Certain Tapered With DCD Implant System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Implant survival
研究概览
简要总结
This will be a prospective, randomized multicenter study to determine the safety and efficacy of the T3 Certain Tapered with DCD as compared to T3 Certain Tapered without DCD. All implants will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years.
详细描述
This is a multicenter, prospective, randomized study that will assess the the safety and efficacy of the implant systems with:
- Resistance to countertorque testing (mobility)
- Implant Stability Quotient (ISQ)
- Changes in peri-implant crestal bone levels
- Confirmation of clinical benefits
A total of 60 implants, 30 per treatment group will be placed across all participating sites. One patient may contribute more than 1 implant. All implants/ patients will be followed for up to 2 years.
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
- 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
- 是
入选标准
- •Patients of either sex and greater than 18 years of age
- •Patients for whom a decision has already been made to use a dental implant in the mandible or maxilla.
- •Immediate extraction or a prior extracted site
- •Patients must be physically able to tolerate conventional surgical and restorative procedures.
- •Presence of opposing dentition
- •Patients who provide a signed informed consent.
- •Patients who agree to be evaluated for each study visit.
- •Minimum primary stability, insertion torque > 35Ncm
排除标准
- •Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
- •Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
- •Patients with active infection or severe inflammation in the areas intended for implant placement.
- •Patients with a > 10 cigarette per day smoking habit.
- •Patients with a history of therapeutic radiation to the head or jaw.
- •Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
- •Patients with evidence of severe parafunctional habits such as bruxing or clenching.
- •Patients with HIV or Hepatitis infection
结局指标
主要结局
Implant survival
时间窗: 2 years
Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement
次要结局
- Peri-implant crestal bone levels(2 years)