NCT02373787终止不适用
A 5 Year Clinical Investigation on Creos Xenoprotect
Nobel Biocare1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2013年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- To demonstrate bone regeneration through measurement of defect height
研究概览
简要总结
A 5-year clinical investigation on creos xenoprotect
详细描述
Randomized, prospective, multi-center study evaluating creos xenoprotect versus Bio-Gide® for guided bone regeneration in dehiscence defects
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, Care Provider, 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
- 否
入选标准
- •Obtained informed consent from the subject.
- •The subject shall be at least 18 years of age and has passed cessation of growth.
- •The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems.
- •The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
- •The subject requires a single unit implant restoration with guided bone regeneration in bony defects in the anterior and premolar areas of maxilla or mandible.
- •If two or more site single unit implant restorations requiring bone augmentation are required, only one will be included in the study, the other site will be treated with standard of care.
- •The subject shall be healthy and compliant with good oral hygiene.
- •Full-mouth bleeding score (FMBS) lower than 25% [20].
- •Full-mouth plaque score (FMPI) lower than 20% [21].
- •The implant site is free from infection and extraction remnants.
- •The subject shall have a favourable and stable occlusal relationship.
- •Natural roots are adjacent to implant site.
- •The subject is suitable for a 2-stage surgical procedure. Secondary inclusion criteria at time of surgery
- •Sufficient bone volume at the implant site for placing a NobelReplace CC implant.
- •Initial implant stability as assessed by hand testing.
- •Defect size for guided bone regeneration:
- •Height ≥ 3 mm and ≤ 7 mm as assessed with a UNC15 periodontal probe.
排除标准
- •Previous bone augmentation at the implant site.
- •Extraction site less than 3 months after extraction.
- •Soft tissue grafting at implant placement, soft tissue grafting is allowed only at re-entry.
- •Health conditions, which do not permit the surgical treatment.
- •Any disorders in the planned implant area such as previous tumours, chronic bone disease or previous irradiation
- •Infections in the planned implantation site or adjacent tissue.
- •Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
- •Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc).
- •Alcohol or substance abuse as noted in subject records or in subject history.
- •Heavy smoking (>10 cigarettes/day).
- •Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.
- •Severe bruxism or other destructive habits.
- •Pregnant or lactating women at the time of collagen membrane insertion.
研究组 & 干预措施
creos xenoprotect
Experimental
resorbable collagen membrane
干预措施: creos xenoprotect (Device)
Bio-Gide
Active Comparator
Bio-Gide, resorbable collagen membrane
干预措施: Bio-Gide (Device)
结局指标
主要结局
To demonstrate bone regeneration through measurement of defect height
时间窗: 6 months
次要结局
- Adverse events (AEs)(6 months)
研究者
研究点 (1)
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