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

NCT06158633 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-12-06

No results posted yet for this study

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 bacteria. Prevora is applied to the teeth and gumline by a medical professional, takes about 10 minutes and is painless.

Participating site(s) have a homecare program and usual care includes offering patients home care services before discharge from the hospital for some chronic diseases. Usual care includes home visits by a nurse and or personal support worker (PSW).

The aim of this study is to explore the effectiveness, health benefits and feasibility of delivering preventive oral healthcare with Prevora, during a homecare visit by a nurse or PSW. All consenting and eligible subjects will continue with their usual care with the homecare program. The study is 5 months long. Subjects will have a Prevora treatment applied by the homecare nurse or PSW on Day 1, 14 days, 3 months and 4 months. The study includes several follow up visits which will be conducted in the patient's home and or by telephone or videoconferencing if needed. Oral exams, lab tests and subject completed questionnaires will be collected for the study. Changes in medications and any possible side effects will also be monitored during the study.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)
  • CHF (Congestive Heart Failure)
  • Dialysis
  • Chronic Metabolic Disorder

Interventions

DRUG

Prevora

Prevora Stage 1, a topical, intra-oral solution of chlorhexidine acetate 100mg/ml followed immediately by Prevora Stage 2 which is a topical solution of polymethylmethacrylate. Prevora Stage 1 and Prevora Stage 2 are applied topically using a small brush and sequentially to the teeth and gum line of the patient/participant. All subjects will receive at total 4 applications of Prevora 1 and 2. One on Day 1, 14 days, 3 months and 4 months.

Sponsors & Collaborators

  • The Research Institute of St Joe's Hamilton

    collaborator UNKNOWN

  • St. Joseph's Health System - Centre for Integrated Comprehensive Care

    collaborator UNKNOWN

  • CHX Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Carrie Beltzner · St. Joseph's Health System - Centre for Integrated Comprehensive Care

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-09-30
Completion
2024-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06158633 on ClinicalTrials.gov