NCT02762201终止不适用
Clinical Evaluation of Therapeutic Efficiency of Implant-secured Removable Partial Denture: A Randomized, Controlled, Prospective Multicentric Study.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- prosthetic success rate
研究概览
简要总结
This study aims to compare the therapeutic efficiency of implant-secured removable partial denture (PASI) with the therapeutic efficiency of the metalic standard removable partial denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.
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
- •Patients with at least a 4 to 6 adjacent teeth intermediate extended-gap (excluding wisdom teeth) in the upper or lower jaw.
- •Patients with at least 4 conservable teeth by dental arch, without major occlusal trouble.
- •Patients with healthy periodontium, allowing metalic standard removable partial denture delivery : bleeding on periodontal probing for a duration less than 30 seconds, Osteolysis of the alveolar ridge less or equal to 50%, attachment loss less or equal to 5mm
- •Patients with a sufficient bone volume for implant placement, without prior bone supply.
排除标准
- •Patients with general counter-indications for implant placement.
- •Patients suffering from a titanium allergy.
- •Patients with an insufficient oral and dental hygiene - Patients smoking ten or more cigarettes per day.
- •Patients with teeth extended-gap, which could be corrected by a fixed tooth-supported denture.
- •Patient with an insufficient available bite level to deliver an attachment system (< 7mm).
- •Patients with a severe generalized chronic periodontitis , an aggressive periodontitis or a periodontitis unresponsive to treatment.
- •Women who have reported to be pregnant.
- •Patients deprived of liberty
研究组 & 干预措施
PASI
Experimental
PASI dental prosthesis delivery
干预措施: PASI (Procedure)
PAC
Active Comparator
PAC dental prosthesis delivery
干预措施: PAC (Procedure)
结局指标
主要结局
prosthetic success rate
时间窗: 5 years after prosthesis delivery
次要结局
- prosthetic success rate(6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery)
研究者
研究点 (1)
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