A Pilot Observation and Feasibility Study of Prevora, Integrated Into Homecare Visits of High-risk Adults

Launched by CHX TECHNOLOGIES INC. · Dec 4, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Prevora, which is used to help prevent tooth decay in adults who are at high risk for dental problems. The study aims to see how well Prevora works when given during homecare visits for patients with chronic health issues like COPD (a lung disease), CHF (a heart condition), or those on dialysis. If you or a loved one is eligible, you would receive Prevora during scheduled home visits by a nurse or personal support worker, along with your usual care.

To be eligible for this study, participants must be at least 18 years old, have certain chronic health conditions that require homecare, and have at least 10 natural teeth. They also need to be willing to provide consent and participate in follow-up visits. Throughout the 5-month study, participants will receive Prevora treatments at specific times and will have their oral health monitored through exams and questionnaires. It's important to note that individuals with certain medical conditions or treatments may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 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 Criteria:
• • 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