Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- General satisfaction Patient reported outcomes
研究概览
简要总结
To establish evidence based guidelines for denture adhesives (powder and cream), multicenter cross over randomized clinical trial will be carried out.
The null hypotheses are that there are no difference on improvement from baseline to post application of two adhesives powder and cream, in terms of general satisfaction, oral related quality of life, masticatory function and oral conditions.
详细描述
This is multicenter study of 10 academic affiliated institutions. The clinical trial will be carried out in randomized allocation at each site, and data will be gathered. The intervention will be 3-arms and center institution (Nihon University) will generate each site random numbers for allocation and each site will follow this randomization. Research protocol had been published at Nihon University and distributed to each site.To survey its protocol compliance, the study meeting will be held periodically (twice an year).
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •edentulous
排除标准
- •Cannot answer the questionnaire
- •Deteriorating general conditions
- •Maxillofacial defect
- •Metal denture user
- •Already denture adhesive users
- •Severe xerostomia
结局指标
主要结局
General satisfaction Patient reported outcomes
时间窗: day 3 of adhesives application
General satisfaction (100mm visual analogue scale)
次要结局
- Moisture Objective outcomes(day 3 of each adhesives application)
- masticatory function(day 3 of each adhesives application)
- retentive force(day 3 of each adhesives application)
- Oral related quality of life(day 3 of adhesives application)