Decrease in chronic oral inflammation in community living (independent and assisted living) older adults and older adults living in long-term care. Oral Health
Conditions
Interventions
Phase A: Residents of the greater Ottawa community, Bruyere Village and Bruyère long-term care will undergo an oral health examination by a registered dental hygienist. The examination will note the n
Sponsors
CHX Technologies Inc
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: Phase A: 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 Phase B: 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
Exclusion criteria: Phase B 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean number of Bleeding on Probing (BOP) sites measured using a periodontal probe during an oral assessment at Screening and Visit 5, active versus control | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the mean number of periodontal pockets between 4 and 5mm, and greater than 5mm, measured using a periodontal probe between Screening and Visit 5, active versus control 2. Change in the mean number of incipient caries lesions identified by visual screening during an oral exam from Screening to Visit 5, active versus control 3. Differences in self-reported tolerance and acceptance to treatment measured using a visual-analogue-scale (VAS), active versus control at Visit 5 4. Differences in self-reported general well-being, as measured using a VAS, active versus control at Visit 5 | — |
Countries
Canada
Contacts
Public ContactJasmine Rooke
Outcome results
None listed