A Clinical trial to study efficacy of Denture Adhesive Cream in Maxillary Complete Dentures
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum dislodgement force
研究概览
简要总结
The study will be a monocentric, single arm, open label, efficacy study. The duration of treatment will be for a period of 1 week on 30 subjects (both males and females); aged between 50-80 years (both inclusive) and will include a total of 2 visits (Baseline, 1 week). The subjects who satisfy inclusion/exclusion criteria will be enrolled after obtaining informed consent. All the subjects in the study will be monitored for signs of adverse events/side effects during the entire study period.
Expected Results: The test denture adhesive should increase significantly the complete maxillary dentures maximum dislodgement force over the control (without denture adhesive) in subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Cases with single maxillary complete denture with natural dentition in mandibular arch [complete or partial (anterior teeth present) In cases of partial arch, anterior teeth should be present in mandibular arch Subjects wearing complete dentures for a minimum period of one year General good health No systemic disease.
排除标准
- •Subjects wearing complete denture (upper & lower dentures) Handicapped & medically compromised subjects Single complete denture cases with duration less than 1 year Patients not satisfied with their denture in terms of retention, stability or occlusion Single complete denture cases with missing mandibular anterior teeth.
- •Those not fulfilling inclusion criteria.
结局指标
主要结局
Maximum dislodgement force
时间窗: Baseline, 1 week
次要结局
未报告次要终点
研究者
Dr. Pankaj Datta
Smile Centre Dental Clinic