ISRCTN14373079已完成4 期
A study to survey the oral health status of Canadian seniors and to prevent poor oral health in Canadian seniors
CHX Technologies Inc0 个研究点目标入组 151 人开始时间: 2023年8月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 151
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Older adults (65 years of age and over at screening)
- •2. Residents of the Greater Ottawa community and Bruyère independent living, assisted living and longterm care
- •1. Matches the criteria of Phase A
- •2. Clears the dental screening performed in Phase A:
- •2.1. Bleeding on probing at = 12 sites at Screening
- •2.2. Minimum of 15 natural teeth
- •2.3. Willing and able to provide informed consent
- •2.4. Able to complete the study as judged by the investigators
- •2.5. Fully vaccinated against COVID 19
排除标准
- •1. Not 65 years of age or over
- •2. No bleeding on probing at 12 or more sites at Screening
- •3. Not having 15 natural teeth or more
- •4. Active caries which, in the judgement of the investigators, could require major surgical restoration and referral to a dentist. Those that can be readily managed by the examining hygienist (for example, small caries only requiring a temporary filling or silver diamine fluoride) will still be included in Part B.
- •5. Severe periodontal disease which, in the judgement of the investigators, could require surgery or a level of periodontal scaling such that participation in the study will be delayed
- •6. Undergoing periodontal care by a dentist or hygienist which in the judgement of the investigators could confound the study results.
- •7. Known allergies to the ingredients of the study medications (chlorhexidine, Sumatra benzoin, ethanol and polymethylmethacrylate)
- •8. Taking anti-inflammatory medication (excluding baby aspirin, prednisone or NSAIDS) or medications for periodontal conditions (e.g. Periostat, chlorhexidine rinse, PerioChip or Arestin).
- •9. At Screening, taking antibiotics for oral abscesses, oral pain or taking antibiotics for more than 14 days
- •10. Uncontrolled epilepsy
- •11. A gag reflex
- •12. Cancer that is in an active stage or has been treated with chemotherapy and/or radiation in the past year or in the next 12 months
- •13. Severe bleeding disorders (given the need to conduct debridement in this study)
- •14. Behavioral disorders which in the judgement of the investigators threaten the patient’s tolerance to treatment and participation in the study
- •15. Involved in another drug trial
- •16. Unwilling or unable to provide informed consent including consent by the Substitute decision maker
- •17. An evident inability to complete the study as judged by the investigators
- •18. Not fully vaccinated against COVID 19
研究者
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