NCT01411683已完成不适用
Mandibular Overdentures Retained by Conventional or Mini Implants: a Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Oral health-related quality of life
研究概览
简要总结
This study aims to compare mandibular overdentures retained either by mini or standard size implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and oral health-related quality of life. We will also evaluate post surgical discomfort, the success rate of prostheses and implants in the long term, denture quality and costs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete edentulism;
- •Request of implant stabilization of the existing lower conventional denture;
- •Clinically acceptable maxillary and mandibular complete dentures;
- •Adequate space in the anterior mandible for the placement of four mini implants and two conventional implants (regular diameter);
- •Ability to maintain adequate oral hygiene and clean dentures;
- •Systemic health status that permits minor surgical procedures;
- •Adequate understanding of written and spoken Portuguese;
- •Capacity of giving written informed consent.
排除标准
- •Lack of minimum vertical mandibular bone height of 11mm in the interforaminal region;
- •Acute or chronic symptoms of parafunctional disorders;
- •History of radiation therapy to the orofacial region;
- •Specific conditions that may jeopardize the treatment, i.e. alcoholism and smoking;
- •Severe/serious illness that requires frequent hospitalization;
- •Impaired cognitive function;
- •Impossibility to return for evaluations/study recalls.
结局指标
主要结局
Oral health-related quality of life
时间窗: 2 years
To be assessed by means of the Brazilian version of the OHIP-EDENT.
Denture satisfaction
时间窗: 2 years
To be assessed by specific questionnaires
次要结局
- Success rate of implant-retained mandibular overdentures(2 years)
- Post-surgical discomfort(7 days)
- Denture quality(2 years)
- Treatment costs(2 years)
研究者
Raphael Freitas de Souza
Associate Professor
University of Sao Paulo
研究点 (2)
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