Clinical Performance Evaluation of a Hyaluronic Acid-coated Hybrid Dental Implant Compared to a Non-Coated Standard Rough Dental Implant: A Pragmatic Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Survival Rate
研究概览
简要总结
In brief, the aim of this randomized controlled trial is to evaluate the patient satisfaction and the clinical performance of two types of implants: 1) HA-coated hybrid dental implant and 2) non-coated moderately rough dental implant. The comparison will be studied during a routine implant placement of experienced dental implantologists.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Both patients and clinicians will be unaware of treatment allocation until the randomization sequence is disclosed. Clinician who will perform test and control treatment will know the group allocation.
Clinician who will do the outcome evaluation will be unaware of the treatment allocation.
A blinded researcher will perform data analysis.
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
- •Signed informed consent to participate to the present investigation
- •Psychological appropriateness and good compliance to dentist instructions
- •Patient who have been selected for implant therapy by an experienced surgeon.
排除标准
- 未提供
结局指标
主要结局
Survival Rate
时间窗: 12 months after implant placement
Cumulative implant survival rate
次要结局
未报告次要终点
研究者
Luca Ferrantino
Researcher
Elite Odontoiatrica