Evaluation of NobelBiocare SFB and CFB Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 主要终点
- The Primary Endpoint Was the Change in Marginal Bone Levels (in mm) From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).
研究概览
简要总结
The purpose of this study is to determine the survival rate, marginal bone resorption, soft tissue health and maintenance of the NobelActive Internal and External implants and to make comparisons with the NobelReplace Tapered Groovy implant placed in healed sites.
详细描述
The purpose of this study is to determine safety and efficacy parameters for the NobelActive Internal and External implants and to make comparisons with the NobelReplace Tapered Groovy implant placed in healed sites.
Safety: AEs
Efficacy:
- survival rates,
- marginal bone resorption with marginal bone levels measurement,
- soft tissue health and maintenance via gingival index measurement, plaque index, papilla index .
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
- 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
- 否
入选标准
- •The subject should be in need of an implant supported fixed restoration
- •The subjects should have sufficient bone volume and density i.e. an osseous architecture in the planned implant placement region sufficient to receive implants with a diameter of 3.5 mm and a length of at least 10 mm.
- •The subject as well as the implant sites should fulfill criteria for immediate functional tem-porization within 24 h.
- •The implant sites should be healed and free from infection.
排除标准
- •Alcohol or drug abuse as noted in patient records or in patient history.
- •Health conditions, which do not permit the surgical procedure.
- •Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in patient records or in patient history.
- •The subject is not able to give her/his informed consent to participate.
- •The need of bone augmentation before implant installation to obtain a prosthetically correct implantation transversally. However, a minor augmentation procedure to cover exposed threads or interproximal / buccal grafting due to deficient sites is not an exclusion criteria.
- •Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
- •Uncontrolled diabetics will be excluded.
- •Severe bruxism or other destructive habits.
- •Immediate insertion (e.g. placement of the implant immediately after extraction) consti-tutes an exclusion criterion.
结局指标
主要结局
The Primary Endpoint Was the Change in Marginal Bone Levels (in mm) From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).
时间窗: baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months
Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline. Missing data was not imputed and not included in evaluation.
次要结局
- Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).(baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months)