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

NCT06158633 | Unknown

• 1 other identifier: CHX2023-002
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

Home healthcare services; Preventive oral care; Chronic oral inflammation

Outcome Measures

Primary Outcomes (2)

• Mean Score Change by Categories of Bleeding on Probing

  To evaluate Prevora's ability to improve oral health in adults with COPD or CHF or on dialysis or with metabolic disorders correlated with chronic oral inflammation, who are receiving home healthcare services.

  Month 0 to Month 5

• Frequency Distribution Change of Study Participants by Categories of Bleeding on Probing

  To evaluate Prevora's ability to improve oral health in adults with COPD or CHF or on dialysis or with metabolic disorders correlated with chronic oral inflammation, who are receiving home healthcare services.

  Month 0 to Month 5

Secondary Outcomes (30)

• Mean Score Change by Categories of Pocket Probing Depth

  Month 0 to Month 5

• Frequency Distribution Change of Study Participants by Categories of Pocket Probing Depth

  Month 0 to Month 5

• Change in Number of Decayed, Missing and Filled Teeth

  Month 0 to Month 5

• Change in Number of Teeth with Active Cavitated Lesions

  Month 0 to Month 5

• Change in Level of Xerostomia

  Month 0 to Month 5

Other Outcomes (3)

• Incidences of adverse events (AE)

  Month 0 to Month 5

• Incidences of serious adverse events (SAE)

  Month 0 to Month 5

• Number of subjects discontinuing investigational product due to AE/SAEs

  Month 0 to Month 5

Study Arms (1)

Active Intervention

All subjects will be in the active treatment group and receive the study intervention. The study intervention is Prevora.

Drug: Prevora

Interventions

Prevora DRUG

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.

Active Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women, ≥18years old, who have COPD and/or CHF or on dialysis or with other chronic metabolic conditions (e.g., diabetes, hypertension) which are correlated with chronic oral inflammation, and which are suitable for homecare conducted by the Integrated Comprehensive Care program.

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CHX Technologies Inc.: lead
• The Research Institute of St Joe's Hamilton: collaborator
• St. Joseph's Health System - Centre for Integrated Comprehensive Care: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Carrie Beltzner

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzana Damjanovic

CONTACT

365-833-8140; DentalStudy@stjoes.ca

Mackensey Bacon

CONTACT

289-659-7241; DentalStudy@stjoes.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: December 6, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share