NCT03041584已完成不适用
Implant-centered Outcomes of Guided Surgery, a 3-year Follow-up: An RCT Comparing Guided Surgery With Non-guided Implant Placement
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 60
- 主要终点
- Radiographic outcome
研究概览
简要总结
To assess implant outcomes, both clinical and radiological, in a randomized study on guided implant placement after 3-year follow-up, compared to non-guided treatment.
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
- Single (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
- •Provision of informed consent
- •An age of at least 18 year
- •Extraction socket healing for at least 6 months
排除标准
- •Unlikely to be able to comply with study procedures
- •History of intravenous bisphosphonate treatment
- •Medical history that makes implant insertion unfavorable
- •Current pregnancy
- •Present alcohol and/or drug abuse
- •Major systemic diseases
- •Untreated, uncontrolled caries and/or periodontal disease
- •History of local irradiation
- •Need for bone grafting and/or sinus lift in the planned implant area
研究组 & 干预措施
FacilitateTM/ bone (Fac Bo)
Experimental
干预措施: Guided placement (Procedure)
FacilitateTM/ bone (Fac Bo)
Experimental
干预措施: Astra Tech TX implant (Device)
mental navigation (Mental)
Active Comparator
干预措施: Astra Tech TX implant (Device)
mental navigation (Mental)
Active Comparator
干预措施: Non-guided placement (Procedure)
pilot-drill template (Templ)
Active Comparator
干预措施: Non-guided placement (Procedure)
pilot-drill template (Templ)
Active Comparator
干预措施: Astra Tech TX implant (Device)
Materialise Universal®/ mucosa (Mat Mu)
Experimental
干预措施: Guided placement (Procedure)
Materialise Universal®/ mucosa (Mat Mu)
Experimental
干预措施: Astra Tech TX implant (Device)
Materialise Universal®/ bone (Mat Bo)
Experimental
干预措施: Guided placement (Procedure)
Materialise Universal®/ bone (Mat Bo)
Experimental
干预措施: Astra Tech TX implant (Device)
FacilitateTM/ mucosa (Fac Mu)
Experimental
干预措施: Guided placement (Procedure)
FacilitateTM/ mucosa (Fac Mu)
Experimental
干预措施: Astra Tech TX implant (Device)
结局指标
主要结局
Radiographic outcome
时间窗: Change between baseline and 3 Year
Bone loss in mm
次要结局
- plaque(Change between baseline and 3 Year)
- bleeding on probing(Change between baseline and 3 Year)
- probing pocket depth(Change between baseline and 3 Year)
研究者
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