ISRCTN14373079
Completed
Phase 4
A study to survey the oral health status of Canadian seniors and to prevent poor oral health in Canadian seniors
CHX Technologies Inc0 sites151 target enrollmentAugust 18, 2023
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Decrease in chronic oral inflammation in community living (independent and assisted living) older adults and older adults living in long-term care.
- Sponsor
- CHX Technologies Inc
- Enrollment
- 151
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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