COPD (Chronic Obstructive Pulmonary Disease)NCT06158633
A Pilot Observation and Feasibility Study of Prevora, Integrated Into Homecare Visits of High-risk Adults
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and CHF (Congestive Heart Failure), run by CHX Technologies Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), CHF (Congestive Heart Failure), Dialysis
- What is being tested?
- Prevora
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot, Observation and Feasibility Study of Prevora (DIN 02046245) Integrated Into Homecare Visits of Adults With COPD or CHF or on Dialysis or Other Chronic Metabolic Conditions Which Are Correlated With Chronic Oral Inflammation
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.
Read the 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 occurs often in patients with chronic diseases who are hospitalized and often continues after discharge from the hospital. This can make health recovery more difficult for the patient.
This is a 5 month, prospective, single-arm, open-label, observational and feasibility, phase IV trial evaluating the efficacy and safety of Prevora and is focused on the integration of a preventive oral healthcare service into a hospital-based home healthcare program involving high-risk adults with COPD or CHF or on dialysis, and possibly other chronic metabolic conditions, which make the patient suitable for entry into a home care program. This study will be centrally coordinated by the Research Institute at St Joes and conducted in the homes of consenting and eligible participants in the greater Hamilton, Ontario area.
Approximately 30 subjects will be enrolled in the study which is defined as starting the investigational product. All subjects will continue to receive the usual care that is provided as part of the respective home care program. After signed consent is obtained, subject screening and eligibility assessments will begin. Once a subject is confirmed to be eligible for study participation, investigational product treatment applications and study visits will be scheduled starting with Day 1.
Follow up visits will occur 14 days, 1, 3, 4 and 5 months after Day 1. A delegated and trained homecare nurse or PSW will apply the investigational product during the study visits conducted on day 1, day 14, 3 and 4 months. Study visits will be scheduled at the same time as a standard of care (SOC) home visit or as a study visit only, independent of a SOC home visit. Study visits include evaluation of study outcomes/endpoints, subject completed questionnaires and measuring compliance. Changes in medications and any possible side effects will also be monitored during the study. Data will be captured in the case report form (CRF).
To qualify, men and women must be enrolled in the home healthcare services program. All participants will receive the study intervention (Prevora) and be followed for 5 months.
This study aims to demonstrate that in subjects who receive home healthcare visits and have COPD and/or CHF or on dialysis, and with moderate to severe forms of chronic oral inflammation, the investigational product (Prevora) will significantly decrease oral inflammation over time.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), CHF (Congestive Heart Failure), Dialysis, Chronic Metabolic Disorder
- Being tested
- Prevora
- Keywords
- Home healthcare services, Preventive oral care, Chronic oral inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevoraDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | All subjects will be in the active treatment group and receive the study intervention. The study intervention is Prevora. Receives: Drug: Prevora |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 0 to Month 5
Secondary outcomes (30)
Mean Score Change by Categories of Pocket Probing Depth
To further evaluate Prevora's ability to improve oral health in adults with COPD or CHF or on dialysis or with chronic metabolic disorders correlated with chronic oral inflammation, who are receiving home healthcare services.
Measured: Month 0 to Month 5
Frequency Distribution Change of Study Participants by Categories of Pocket Probing Depth
To further evaluate Prevora's ability to improve oral health in adults with COPD or CHF or on dialysis or with chronic metabolic disorders correlated with chronic oral inflammation, who are receiving home healthcare services.
Measured: Month 0 to Month 5
Change in Number of Decayed, Missing and Filled Teeth
To assess the oral health status of study participants by way of an oral health examination conducted by a mobile independent hygienist in the home.
Measured: Month 0 to Month 5
Change in Number of Teeth with Active Cavitated Lesions
To assess the oral health status of study participants by way of an oral health examination conducted by a mobile independent hygienist in the home.
Measured: Month 0 to Month 5
Change in Level of Xerostomia
To assess the oral health status of study participants by way of an oral health examination conducted by a mobile independent hygienist in the home.
Measured: Month 0 to Month 5
Mean Score Change in hsCRP (high sensitivity C-reactive protein)
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Change in Frequency Distribution of hsCRP (high sensitivity C-reactive protein)
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Mean Score Change in ESR (Erythrocyte Sedimentation Rate)
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Change in Frequency Distribution of ESR (Erythrocyte Sedimentation Rate)
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Mean Score Change in Cholesterol
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Change in Frequency Distribution of Cholesterol
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Mean Score Change in Blood Glucose
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Change in Frequency Distribution of Blood Glucose
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Mean Score Change in HbA1c
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Change in Frequency Distribution of HbA1c
To evaluate Prevora's ability to change blood-based markers of inflammation.
Measured: Month 0 to Month 5
Change in Mean Scores of Subject Self-Reported Shortness of Breath using a Visual Analogue Scale in Chronic Obstructive Pulmonary Disease participants only.
To evaluate Prevora's effect on self reported shortness of breath in COPD participants.
Scale title: Visual Analogue Scale Assessment for Degree of Breathlessness Minimum Value: 0 Maximum Value: 100 Higher Score equals a worse outcome
Measured: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Frequency Distribution of Subject Self-Reported Shortness of Breath using a Visual Analogue Scale in Chronic Obstructive Pulmonary Disease participants only.
To evaluate Prevora's effect on self reported shortness of breath in COPD participants.
Scale title: Visual Analogue Scale Assessment for Degree of Breathlessness Minimum Value: 0 Maximum Value: 100 Higher Score equals a worse outcome
Measured: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Mean Scores of Subject Self-Reported Ankle Swelling using a Visual Analogue Scale in Congestive Heart Failure subjects only.
To evaluate Prevora's effect on self reported ankle swelling in CHF participants.
Scale title: Visual Analogue Scale Assessment for Degree of Ankle Swelling Minimum Value: 0 Maximum Value: 100 Higher Score equals a worse outcome
Measured: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Frequency Distribution of Subject Self-Reported Ankle Swelling using a Visual Analogue Scale in Congestive Heart Failure subjects only.
To evaluate Prevora's effect on self reported ankle swelling in CHF participants.
Scale title: Visual Analogue Scale Assessment for Degree of Ankle Swelling Minimum Value: 0 Maximum Value: 100 Higher Score equals a worse outcome
Measured: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Mean Scores of Subject Self-Reported Fatigue using a Visual Analogue Scale in Congestive Heart Failure subjects only.
To evaluate Prevora's effect on self reported fatigue in CHF participants. Scale title: Visual Analogue Scale Assessment for Degree of Fatigue Minimum Value: 0 Maximum Value: 100 Higher Score equals a worse outcome
Measured: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Frequency Distribution of Subject Self-Reported Fatigue using a Visual Analogue Scale in Congestive Heart Failure subjects only.
To evaluate Prevora's effect on self reported fatigue in CHF participants. Scale title: Visual Analogue Scale Assessment for Degree of Fatigue Minimum Value: 0 Maximum Value: 100 Higher Score equals a worse outcome
Measured: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Mean Scores of Subject Self-Reported Energy Level using a Visual Analogue Scale in subjects on dialysis only
To evaluate Prevora's effect on self reported energy level in participants on dialysis.
Scale title: Visual Analogue Scale Assessment of Energy Levels Minimum Value: 0 Maximum Value: 100 Higher Score equals a better outcome
Measured: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Frequency Distribution of Subject Self-Reported Energy Level using a Visual Analogue Scale in subjects on dialysis only.
To evaluate Prevora's effect on self reported energy level in participants on dialysis.
Scale title: Visual Analogue Scale Assessment of Energy Levels Minimum Value: 0 Maximum Value: 100 Higher Score equals a better outcome
Measured: Month 0, Day 1, 14 days, Month 3, 4 and 5
Subject Self-Reported Tolerance to Study Intervention measured using a Visual Analogue Scale in all subjects Scale title: Visual Analogue Scale Assessment Acceptability Minimum Value: 0 Maximum Value: 100 Higher Score equals a better outcome
To evaluate qualitative measures of Prevora's treatment effect in terms of a survey of participants for tolerability to treatment.
Scale title: Visual Analogue Scale Assessment Acceptability Minimum Value: 0 Maximum Value: 100 Higher Score equals a better outcome
Measured: Month 5 only
Subject Self-Reported General Well-being measured using a Visual Analogue Scale in all subjects
To evaluate qualitative measures of Prevora's treatment effect in terms of a survey of participants for general well-being.
Scale title: Visual Analogue Scale Assessment of Importance of Treatment Minimum Value: 0 Maximum Value: 100 Higher Score equals a better outcome
Measured: Month 5 only
Subject Self-Reported Willingness to Continue Study Intervention, measured using a Visual Analogue Scale in all subjects
To evaluate qualitative measures of Prevora's treatment effect in terms of a survey of participants for willingness to continue treatment.
Scale title: Visual Analogue Scale Assessment of Willingness to Continue Treatment Post-Study Minimum Value: 0 Maximum Value: 100 Higher Score equals a better outcome
Measured: Month 5 only
Mean time to administer Prevora by homecare provider
To evaluate the feasibility of integrating preventive oral health services into a home healthcare program, including training of the homecare provider, logistics, costs, and revenues so as to define best practices for integration.
Measured: Day 1, 14 days, Months 3 and 4
Adequacy, comprehension, competence and confidence of the homecare provider as measured by survey
To evaluate the feasibility of integrating preventive oral health services into a home healthcare program, including training of the homecare provider, logistics, costs, and revenues so as to define best practices for integration. Study intervention is applied by homecare providers. This survey is completed by homecare provider, not participants.
Measured: At end of study or when homecare provider ends involvement with study
Logistics of administering Prevora in the home as measured by survey
To evaluate the feasibility of integrating preventive oral health services into a home healthcare program, including training of the homecare provider, logistics, costs, and revenues so as to define best practices for integration. Study intervention is applied by homecare providers. This questionnaire is completed by homecare provider(s), not participants.
Measured: At end of study or when homecare provider ends involvement with study
Percentage of subjects who are adherent to Prevora treatment regimen
To determine adherence or compliance to investigational product.
Measured: Day 1 to Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHX Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Research Institute of St Joe's Hamilton, St. Joseph's Health System - Centre for Integrated Comprehensive Care
- Responsible party
- Sponsor
- Investigators
- Carrie Beltzner, Principal investigator, St. Joseph's Health System - Centre for Integrated Comprehensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158633
- Sponsor's protocol ID
- CHX2023-002
- Status last verified
- Dec 2023
- First submitted
- 10 Oct 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Observation and Feasibility Study of Prevora (DIN 02046245) Integrated Into Homecare Visits of Adults With COPD or CHF or on Dialysis or Other Chronic Metabolic Conditions Which Are Correlated With Chronic Oral Inflammation
- ClinicalTrials.gov ID
- NCT06158633
- Acronym / sponsor ID
- CHX2023-002
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), CHF (Congestive Heart Failure), Dialysis, Chronic Metabolic Disorder
- Keywords
- Home healthcare services, Preventive oral care, Chronic oral inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CHX Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Research Institute of St Joe's Hamilton, St. Joseph's Health System - Centre for Integrated Comprehensive Care
- Study start
- Dec 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 occurs often in patients with chronic diseases who are hospitalized and often continues after discharge from the hospital. This can make health recovery more difficult for the patient.
This is a 5 month, prospective, single-arm, open-label, observational and feasibility, phase IV trial evaluating the efficacy and safety of Prevora and is focused on the integration of a preventive oral healthcare service into a hospital-based home healthcare program involving high-risk adults with COPD or CHF or on dialysis, and possibly other chronic metabolic conditions, which make the patient suitable for entry into a home care program. This study will be centrally coordinated by the Research Institute at St Joes and conducted in the homes of consenting and eligible participants in the greater Hamilton, Ontario area.
Approximately 30 subjects will be enrolled in the study which is defined as starting the investigational product. All subjects will continue to receive the usual care that is provided as part of the respective home care program. After signed consent is obtained, subject screening and eligibility assessments will begin. Once a subject is confirmed to be eligible for study participation, investigational product treatment applications and study visits will be scheduled starting with Day 1.
Follow up visits will occur 14 days, 1, 3, 4 and 5 months after Day 1. A delegated and trained homecare nurse or PSW will apply the investigational product during the study visits conducted on day 1, day 14, 3 and 4 months. Study visits will be scheduled at the same time as a standard of care (SOC) home visit or as a study visit only, independent of a SOC home visit. Study visits include evaluation of study outcomes/endpoints, subject completed questionnaires and measuring compliance. Changes in medications and any possible side effects will also be monitored during the study. Data will be captured in the case report form (CRF).
To qualify, men and women must be enrolled in the home healthcare services program. All participants will receive the study intervention (Prevora) and be followed for 5 months.
This study aims to demonstrate that in subjects who receive home healthcare visits and have COPD and/or CHF or on dialysis, and with moderate to severe forms of chronic oral inflammation, the investigational product (Prevora) will significantly decrease oral inflammation over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | – | Drug: PrevoraAll subjects will be in the active treatment group and receive the study intervention. The study intervention is Prevora. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- ≥ 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrevoraPrevora 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. | Drug | Active Intervention |
Primary outcome
Mean Score Change by Categories of Bleeding on Probing
Time frame: Month 0 to Month 5
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.
Frequency Distribution Change of Study Participants by Categories of Bleeding on Probing
Time frame: Month 0 to Month 5
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.
30 secondary outcomes
Mean Score Change by Categories of Pocket Probing Depth
Time frame: Month 0 to Month 5
Frequency Distribution Change of Study Participants by Categories of Pocket Probing Depth
Time frame: Month 0 to Month 5
Change in Number of Decayed, Missing and Filled Teeth
Time frame: Month 0 to Month 5
Change in Number of Teeth with Active Cavitated Lesions
Time frame: Month 0 to Month 5
Change in Level of Xerostomia
Time frame: Month 0 to Month 5
Mean Score Change in hsCRP (high sensitivity C-reactive protein)
Time frame: Month 0 to Month 5
Change in Frequency Distribution of hsCRP (high sensitivity C-reactive protein)
Time frame: Month 0 to Month 5
Mean Score Change in ESR (Erythrocyte Sedimentation Rate)
Time frame: Month 0 to Month 5
Change in Frequency Distribution of ESR (Erythrocyte Sedimentation Rate)
Time frame: Month 0 to Month 5
Mean Score Change in Cholesterol
Time frame: Month 0 to Month 5
Change in Frequency Distribution of Cholesterol
Time frame: Month 0 to Month 5
Mean Score Change in Blood Glucose
Time frame: Month 0 to Month 5
Change in Frequency Distribution of Blood Glucose
Time frame: Month 0 to Month 5
Mean Score Change in HbA1c
Time frame: Month 0 to Month 5
Change in Frequency Distribution of HbA1c
Time frame: Month 0 to Month 5
Change in Mean Scores of Subject Self-Reported Shortness of Breath using a Visual Analogue Scale in Chronic Obstructive Pulmonary Disease participants only.
Time frame: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Frequency Distribution of Subject Self-Reported Shortness of Breath using a Visual Analogue Scale in Chronic Obstructive Pulmonary Disease participants only.
Time frame: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Mean Scores of Subject Self-Reported Ankle Swelling using a Visual Analogue Scale in Congestive Heart Failure subjects only.
Time frame: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Frequency Distribution of Subject Self-Reported Ankle Swelling using a Visual Analogue Scale in Congestive Heart Failure subjects only.
Time frame: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Mean Scores of Subject Self-Reported Fatigue using a Visual Analogue Scale in Congestive Heart Failure subjects only.
Time frame: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Frequency Distribution of Subject Self-Reported Fatigue using a Visual Analogue Scale in Congestive Heart Failure subjects only.
Time frame: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Mean Scores of Subject Self-Reported Energy Level using a Visual Analogue Scale in subjects on dialysis only
Time frame: Month 0, Day 1, 14 days, Month 3, 4 and 5
Change in Frequency Distribution of Subject Self-Reported Energy Level using a Visual Analogue Scale in subjects on dialysis only.
Time frame: Month 0, Day 1, 14 days, Month 3, 4 and 5
Subject Self-Reported Tolerance to Study Intervention measured using a Visual Analogue Scale in all subjects Scale title: Visual Analogue Scale Assessment Acceptability Minimum Value: 0 Maximum Value: 100 Higher Score equals a better outcome
Time frame: Month 5 only
Subject Self-Reported General Well-being measured using a Visual Analogue Scale in all subjects
Time frame: Month 5 only
Subject Self-Reported Willingness to Continue Study Intervention, measured using a Visual Analogue Scale in all subjects
Time frame: Month 5 only
Mean time to administer Prevora by homecare provider
Time frame: Day 1, 14 days, Months 3 and 4
Adequacy, comprehension, competence and confidence of the homecare provider as measured by survey
Time frame: At end of study or when homecare provider ends involvement with study
Logistics of administering Prevora in the home as measured by survey
Time frame: At end of study or when homecare provider ends involvement with study
Percentage of subjects who are adherent to Prevora treatment regimen
Time frame: Day 1 to Month 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Beltzner principal investigator
St. Joseph's Health System - Centre for Integrated Comprehensive Care
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and CHF (Congestive Heart Failure), run by CHX Technologies Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzana Damjanovic (365-833-8140, DentalStudy@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score Change by Categories of Bleeding on Probing (time frame: Month 0 to Month 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.