Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- Marginal Bone Remodeling
研究概览
简要总结
The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate, soft tissue health and maintenance.
详细描述
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, 36 and 60 months).
Further endpoints were:
- cumulative survival rates of the implants
- soft tissue parameters (papilla index, bleeding on probing)
- plaque formation
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 subjects should have an osseous architecture enough to receive an implant with a diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length of 7 mm.
- •The final tightening torque at installation should be 35-45 Ncm without further rotation and should not exceed 45 Ncm.
- •The subject as well as the implant site(s) should fulfill criteria for immediate provizionalization.
- •Immediate insertion (e.g. placement of the implant immediately after extraction) will not constitute an exclusion criterion.
- •The implants site(s) should be free from extraction remnants.
- •The subject should be healthy and compliant with good oral hygiene.
- •The subject should be available for the 5-year term of the investigation.
- •Favorable and stable occlusal relationship
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.
- •Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
- •Severe bruxism or other destructive habits.
研究组 & 干预措施
Shorty implants
Brånemark System Mk III Shorty and/or NobelSpeedy Shorty
干预措施: Shorty implants (Device)
结局指标
主要结局
Marginal Bone Remodeling
时间窗: from implant insertion to 6, 12, 36 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
- Cumulative Survival Rates of the Implants(implant insertion to follow-up visits (6, 12, 36 and 60 months))