Evaluation of B+ Surface on Early Loading
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007
研究概览
简要总结
The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient >18 and ≤75 years old
- •One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).
排除标准
- •One-stage bone augmentation
- •Heavy smokers (>10 cigarettes/day)
- •Uncontrolled type 1 or 2 diabetes (HgA1c>8)
- •Known auto-immune or inflammatory disease
- •Severe hematologic disorders, such as hemophilia or leukemia
- •Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology)
- •Liver or kidney dysfunction/failure
- •Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy
- •Long-term history of oral bisphosphonates use (i.e., 10 years or more)
- •History of intravenous bisphosphonates
- •Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system
- •Severe osseous diseases (e.g., Paget disease of bone)
- •Pregnant women or nursing mothers
- •Not able or not willing to follow instructions related to the study procedures
研究组 & 干预措施
Early Loading
Implant early loading: prosthesis delivery 4 weeks after implant placement
干预措施: Early Loading (Procedure)
Conventional Loading
Implant conventional loading: prosthesis delivery 8 weeks after implant placement
干预措施: Conventional Loading (Procedure)
结局指标
主要结局
Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007
时间窗: 12 months
次要结局
- Change in marginal bone level around B+-treated implants after conventional or early loading protocol(0 (Baseline: prosthesis delivery), 3, 6, and 12 months)
- Change in the microbiological profile around B+-treated implants after conventional or early loading protocol(-14 (before impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months)
- Change in inflammatory markers in peri-implant crevicular fluid around B+-treated implants after conventional or early loading protocol(-14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months)
研究者
Pablo Galindo-Moreno
Professor
Universidad de Granada