NCT01064843已完成不适用
Clinical Evaluation of the Mandibular Mini-Implant Overdenture
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.
研究概览
简要总结
Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test whether 4 mini-implants placed at the front of the lower jaw can stabilize an immediately-modified existing lower denture.
详细描述
To test whether the percentage of case successes of these lower dentures supported by 4 MDIs is equal to or greater than 95% at 1 year. Success is defined as a denture supported by implants that is functioning in the way it was intended.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completely edentulous with last tooth extraction 2 years ago or longer.
- •Patients requesting implant stabilization of existing lower conventional denture.
- •Adequate space in anterior mandible for placement of 4 MDI implants.
- •Able to maintain adequate oral hygiene and keep dentures clean.
- •Healthy enough to have minor surgical procedures.
- •Have adequate understanding of written and spoken English or French.
- •Capable of providing written informed consent.
排除标准
- •Not enough room in mandibular bone for implant height.
- •Has acute or chronic symptoms of parafunctional disorders.
- •History of radiotherapy to orofacial region.
- •Are or have been taking bisphosphonate IV or other medications (to be evaluated by the researcher).
- •Health conditions that may jeopardize treatment (to be evaluated by the researcher).
- •Unable or unwilling to return for evaluations or study recalls.
结局指标
主要结局
Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.
时间窗: 3 years
次要结局
- Oral health-related quality of life and general satisfaction of patients.(3 years)
研究者
研究点 (1)
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