NCT02656823已完成不适用
Implant-fixed Restorations With Short Implants in the Edentulous Maxilla - A Clinical Investigation Over a 5-year Follow-up Period
Dentsply Sirona Implants and Consumables2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年11月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Implant Survival Rate
研究概览
简要总结
Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.
详细描述
Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function. The primary objective was to evaluate implant survival.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the study subjects had to meet all of the following criteria:
- •Aged 18-80 years at inclusion.
- •Signed informed consent.
- •In need of full-arch restoration of the maxilla.
- •The following should be considered at inclusion but should be fulfilled at Implant Placement (Visit 3):
- •Maxilla: totally edentulous, fulfilling all of the following criteria:
- •History of edentulism: ≥ 6 months and,
- •Minimum bone height: ≥ 7 mm and,
- •Minimum bone width: ≥ 5.5 mm.
- •Mandible: antagonistic natural dentition or tooth/implant borne rehabilitation which can be used to create a stable occlusal fit with the new full-arch restoration of the upper jaw.
排除标准
- •Any of the following was regarded as a criterion for exclusion from the study:
- •Unlikely to be able to comply with study procedures according to Investigator's judgement.
- •History of bone augmentation in the maxilla within 6 months prior to surgery.
- •Uncontrolled pathologic processes in the oral cavity.
- •Smoking >10 cigarettes per day.
- •Present alcohol or drug abuse.
- •History of radiation therapy in head and neck region.
- •History of chemotherapy within 5 years prior to surgery.
- •Condition that would compromise post-operative tissue healing or osseointegration.
- •Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration.
- •Known pregnancy at time of inclusion.
- •Current or former participation in a clinical study that may interfere with the present study.
- •Involvement in the planning and conduct of the study.
结局指标
主要结局
Implant Survival Rate
时间窗: At Visit 14, 5 years after permanent restoration (PR).
Any implant that is removed after implant placement will be considered failure, whatever reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants.
次要结局
- At Least One Surface With Plaque.(At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).)
- Oral Health Impact Profile 14 (OHIP-14)(At pre-surgical planning (Visit 2) on average 6 months before PR, and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).)
- Mean Marginal Bone Level (MBL) at Subject's Tissue Level(At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).)
- Any Bleeding on Implant (BoP)(At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).)
- Mean Probing Pocket Depth (PPD) at Subject Level.(At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).)
- Implant Stability(At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP).)
- Prosthetic Survival Rate on Subject Level(At 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).)
- Mean Marginal Bone Level (MBL) on Implant Level.(At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).)
研究者
研究点 (2)
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