NCT03041597已完成不适用
An Randomized Controlled Trial Comparing Immediate Loading With Conventional Loading Using Cone-anchored Implant Supported Removable Dental Prostheses, a Two Year Follow up
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 15
- 主要终点
- bone loss
研究概览
简要总结
To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the SynCone® concept for implant-supported detachable dental prosthesis (ISDDP) in the edentulous upper jaw.
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
- Double (Investigator, 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
- 是
入选标准
- •Provision of informed consent
- •Extraction sockets should have healed at least 4 months
- •Sufficient bone volume to place six implants in the maxilla
- •No previous bone augmentation procedures
- •The mandible can have any kind of dentition as long as a well-distributed contact relationship with the new prosthesis in the maxilla can be established.
- •Accepting to comply with study procedures
排除标准
- •Physical or psychological disorders prohibiting implant treatment
- •Heavy smoking (>10 cigarettes/day)
- •Present alcohol and/or drug abuse
- •Physical handicap that may interfere with the ability to perform oral hygiene
研究组 & 干预措施
Immediate loading
Experimental
干预措施: immediate loading (Procedure)
Immediate loading
Experimental
干预措施: Ankylos implant (Device)
Immediate loading
Experimental
干预措施: placement of implants (Procedure)
delayed loading
Active Comparator
干预措施: placement of implants (Procedure)
delayed loading
Active Comparator
干预措施: conventional loading (Procedure)
delayed loading
Active Comparator
干预措施: Ankylos implant (Device)
结局指标
主要结局
bone loss
时间窗: Difference between loading and Year two
measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.
次要结局
- plaque(Difference between loading and Year two)
- probing pocket depth(Difference between loading and Year two)
- bleeding on probing(Difference between loading and Year two)
研究者
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