Evaluation of MT-12 Implant Survival and Marginal Bone Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Marginal bone level
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 patient will be randomized to receive one of the two types of implants (Control: internal hexagon connection implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage surgery), -14 (impressions), 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
- Double (Participant, 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
- •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 3 months before inclusion
- •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
MT-12 dental implant
MT-12 dental implant with Morse taper implant-abutment connection
干预措施: MT-12 dental implant (Device)
CON.INT dental implant
CON.INT dental implant with internal hexagon implant-abutment connection
干预措施: CON.INT dental implant (Device)
结局指标
主要结局
Marginal bone level
时间窗: 1 year
次要结局
- Peri-implant microbial contamination(1 year)
- Peri-implant inflammation(1 year)
研究者
Pablo Galindo-Moreno
Professor
Universidad de Granada