Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Marginal bone level
研究概览
简要总结
Dental implants may suffer from bone loss around them, particularly at the upper portion where the prosthesis starts. The connection between both parts of the tooth restoration is key for avoiding micromovement during chewing, bacterial contamination and initiation of bone loss. Thus, investigating factors related to this bone loss in different types of implant-prosthetic connections is key for promoting better use of available therapeutics devices. In this study, we will study marginal bone levels over time as well as bacterial contamination and inflammatory markers in the peri-implant sulcus around implants with connical connection and compare them with those obtained when using implants with internal hexagonal connection. The hypothesis is that bone loss will be higher in implants with hexagonal connection associated with a pathological microbiome in the sulcus that induces a higher inflammatory response.
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 (Participant)
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
- •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
Ziacom Galaxy dental implant with internal connical prosthetic connection
Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection
干预措施: Ziacom Galaxy dental implant with internal connical prosthetic connection (Device)
Ziacom Zinic dental implant with internal hexagonal prosthetic connection
Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection
干预措施: Ziacom Zinic dental implant with internal hexagonal prosthetic connection (Device)
结局指标
主要结局
Marginal bone level
时间窗: 1 year
次要结局
- Peri-implant microbiome(1 year)
- Peri-implant inflammation(1 year)
研究者
Miguel Padial-Molina
Associate Professor
Universidad de Granada