Trials to Enhance Elders' Teeth and Oral Health
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,101
- 试验地点
- 4
- 主要终点
- regular rinsing with chlorhexidine is effective method for reducing the incidence of tooth loss in low income older adults.
研究概览
简要总结
The purpose of this study is to determine if regular rinsing with chlorhexidine is effective as a long-term preventive method for reducing the incidence of tooth loss in low income older adults. The true end-point of the study is tooth loss after five years of regular rinsing with chlorhexidine or a placebo; surrogate endpoints are periodontal disease, root and coronal decay.
详细描述
"TEETH" is a double-blinded, randomized clinical trial, supervised by a Data & Safety Monitoring Board, designed to provide unequivocal evidence regarding the impact of regular rinsing 0.12% chlorhexidine solution on tooth loss in low income, community-dwelling older adults who are irregular users of dental services. Of the 1101 subjects enrolled in the study in Seattle, WA and Vancouver, B.C., one/half have been assigned to the active rinse condition; the other half to the placebo rinse which looks and tastes like the chlorhexidine rinse but does not have the active ingredient. Subjects receive two bottles of rinse every six months; the first to be used daily for one month, the second weekly for five months. Reminder calls are designed to help subjects maintain this rinse regimen. Subjects return yearly to research clinics at each participating university, where they are examined by a dentist who is trained in clinical research methodology and calibrated annually. The purpose of these visits is to examine subjects for tooth loss (followed by contacts with extracting dentists to determine the dentist's reasons for extracting the tooth), pocket depth, recession, caries and restorations on root and coronal surfaces. Interviews are also conducted annually with participants to assess health status, health behaviors, and oral health quality of life. A panoramic radiograph was taken at baseline of each subject and is to be done again at the five-year (final) yearly exam. These radiographs are used to confirm tooth loss and possible reasons for extractions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at entry 60-75
- •Four or more natural teeth
- •No preventive dental visits in the past 18 months
- •Scores > or = 60 on a measure of oral health self-efficacy (max possible=100)
- •willing to participate in a five-year study
- •willing to use rinses on a prescribed regimen and to return for yearly cleaning and exam appointments.
排除标准
- •Not having a phone at home for follow-up calls
结局指标
主要结局
regular rinsing with chlorhexidine is effective method for reducing the incidence of tooth loss in low income older adults.
时间窗: five years of regular rinsing
次要结局
未报告次要终点
