Sterilized Aseptic Versus Sterilized Clean Field for Dental Implant Placement - Randomized Clinical Control Trial for Non-inferiority Comparison
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Osseointegration
研究概览
简要总结
In patients that require dental implants , does performing the surgery in clean sterile field compared to aseptic field, produces more post-operatory complications, implant morbidity or patient discomfort ?
详细描述
The investigators intend to compare two types of operatory room preparation (aseptic versus clean), used world wide, for placing dental implants.
The investigators want to see if it has impact on post-operatory healing, osseointegration and success rate of dental implants.
Before Study begins the investigators will perform inter-observer agreement in surgical preparation of the surgical suite, implant placements and operatory-room behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •All surgeries schedule for implant placement
排除标准
- •Surgeries not made with local anesthesia
结局指标
主要结局
Osseointegration
时间窗: At 8 weeks (T2) after Baseline
Measure the ability of dental implants to integrate into bone in both groups (aseptic vs clean)
Post-Operatory Complications
时间窗: From Implant Placement (Baseline) to 4 weeks after (T1)
Measure the amount of adverse effects in both groups (aseptic vs clean) that happen between time frame baseline to 4 weeks.
次要结局
- Marginal bone loss(At Final Restoration placement - Expected Average of 12 Weeks after baseline)
- Patient Satisfaction(At 2 weeks)
研究者
Andre Chen
Msc
Implantology Institute