A study to survey the oral health status of Canadian seniors and to prevent poor oral health in Canadian seniors
- Conditions
- Decrease in chronic oral inflammation in community living (independent and assisted living) older adults and older adults living in long-term care.Oral Health
- Registration Number
- ISRCTN14373079
- Lead Sponsor
- CHX Technologies Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 151
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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<br>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 <br>3. Differences in self-reported tolerance and acceptance to treatment measured using a visual-analogue-scale (VAS), active versus control at Visit 5<br>4. Differences in self-reported general well-being, as measured using a VAS, active versus control at Visit 5<br>