Development of Minimally Invasive Splinted Dental Implants to Stabilize Mandibular Overdentures, a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change in Quality of Life
研究概览
简要总结
The purpose of this study was to evaluate the effect of a integrated system for inserting two splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of life of edentulous patients.
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
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Edentulous
- •Men and women
- •Between 45 and 90 years of age
- •Who had a persistent loss of stability and retention of their conventional mandibular dentures
- •Without temporomandibular disorders
排除标准
- •Uncontrolled systemic disease (eg, hypertension, diabetes)
- •Severe osteoporosis (bone mineral density > 2.5 SD below the young adult reference mean, plus 1 or more fragility fractures) and/or taking bisphosphonates
- •Mental disorders
- •Who had received radiotherapy in the 18 months prior to the trial
研究组 & 干预措施
Integrated system to insert two splinted (bar) miniimplants
Participants were randomly assigned to experimental group following a simple randomization procedure (computer-generated list of random numbers). Allocation by telephone was carried out with an independent collaborator.
干预措施: Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture (Device)
Denture
Participants were randomly assigned to comparator group following a simple randomization procedure (computer-generated list of random numbers). Allocation by telephone was carried out with an independent collaborator.
干预措施: Denture (Other)
结局指标
主要结局
Change in Quality of Life
时间窗: One year
Quality of life was assessed using the Oral Health Impact Profile (OHIP) for assessing health-related quality of life in edentulous adults (EDENT) scale with 19 items.
次要结局
- Incidence of complications(Two years)
研究者
Jorge Jofre
Jorge Jofre DDs, PhD
University of Concepcion, Chile