NCT02178891Unknown不适用
A 5-year Clinical Evaluation on Brånemark System® RP Ø4.5x4.5 mm Implants
Nobel Biocare2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2010年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- marginal bone level changes
研究概览
简要总结
An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone anchoring length of only 4.5 mm, for subjects with severely resorbed jaws.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The subject should be at least 18 years of age and have passed secession of growth
- •The subject should be in need of an implant-supported restoration in the posterior region of the mouth (maxilla: first premolar to third molar, mandible: first premolar to second molar, not third molar due to mobile gingiva), where at least 2 implants are needed of which at least one should be an Extra Short Implant
- •Obtained informed consent from the subject
- •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 subject should have a severely resorbed posterior mandible and/ or maxilla.
- •Implants are only to be placed in healed sites, defined as a site with minimum 6 months of healing following tooth extraction
- •At least 6 mm residual bone width, between 4-7 mm residual bone height in the maxilla and between 6-9 mm residual bone height in the mandible
- •At implant installation the implant should be stable; final tightening torque of the implant about 25 Ncm or higher, preferably not exceeding 45 Ncm
- •The subject should be healthy and compliant with good oral hygiene
- •Favorable and stable occlusal relationship
排除标准
- •The subject is not able to give her/his informed consent of participating
- •Health conditions, which do not permit the surgical treatment
- •Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in subject records or in subject history
- •Any disorders in the planned implant area such as previous tumours, chronic bone disease or previous irradiation
- •Alcohol or drug abuse as noted in subject records or in subject history.
- •Heavy smoking (>10 cigarettes/day)
- •Intake of medication containing bisphosphonates
- •Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
- •Severe bruxism or other destructive habits
- •Immediate insertion (i.e. placement of the implant immediately after extraction)
- •Bone augmentation procedures before or at implant installation is not allowed
- •Deviation from stated drilling protocol, utilizing osteotomes, is not allowed
- •Lack of opposing dentition
- •Single crown restorations are not to be performed in the study
研究组 & 干预措施
short implants
Other
干预措施: extra short implant (Device)
结局指标
主要结局
marginal bone level changes
时间窗: yearly, up to 5 years
次要结局
- cumulative survival and success rates(yearly, up to 5 years)
研究者
研究点 (2)
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