Status:
UNKNOWN
A Pilot Observation and Feasibility Study of Prevora, Integrated Into Homecare Visits of High-risk Adults
Lead Sponsor:
CHX Technologies Inc.
Collaborating Sponsors:
The Research Institute of St Joe's Hamilton
St. Joseph's Health System - Centre for Integrated Comprehensive Care
Conditions:
COPD (Chronic Obstructive Pulmonary Disease)
CHF (Congestive Heart Failure)
Eligibility:
All Genders
18+ years
Brief Summary
Prevora is an antiseptic medication and dental treatment approved by Health Canada for reducing root decay (cavities) in adults at high risk of dental decay. An antiseptic kills germs and harmful bact...
Detailed Description
Poor oral health and specifically, inflammation of the gums is linked to respiratory problems, heart problems and inflammation through the body. Worsening oral health and inflammation of the gums occu...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Enrollment in the homecare COPD/CHF program or who possibly have other medical conditions such as on dialysis or chronic metabolic condition (e.g. diabetes, hypertension) suitable for entry into the home care program
- Bleeding on probing at ≥ 12 sites at Screening
- Minimum of 10 natural teeth
- Willing and able to provide informed consent as per International Conference on Harmonization - Good Clinical Practices Guidelines (ICH-GCP E6(R2)) and applicable regulations.
Exclusion
- Currently smoking one or more cigarettes per day
- Patients with a prosthetic heart valve
- Active visual caries which, in the judgement of the investigators, could require surgical restoration or extraction, and referral to a dentist on an urgent basis
- 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
- Undergoing periodontal care by a dentist or hygienist which in the judgement of the investigators could confound the study results
- Known allergies to the ingredients of the study medications (chlorhexidine, Sumatra benzoin, ethanol and polymethylmethacrylate)
- Taking medications for periodontal conditions (e.g., Periostat, chlorhexidine rinse, PerioChip or Arestin).
- Uncontrolled seizure disorder
- A gag reflex
- Cancer that is in an active stage of treatment or has been treated with chemotherapy and/or radiation in the past year or in the next 12 months
- Behavioural disorders which in the judgement of the investigators threaten the patient's tolerance to treatment and participation in the study
- Involved in another drug trial
- Not able to complete subject reported, self-administered questionnaires or not able have a caregiver complete these questionnaires, or cannot fully understand all instructions in English
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06158633
Start Date
December 1 2023
End Date
October 1 2024
Last Update
December 6 2023
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