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NCT06158633
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
trial testing Prevora in COPD (Chronic Obstructive Pulmonary Disease) in 30 participants. Status unknown.
1 September 2024
Quick facts
| Lead sponsor | CHX Technologies Inc. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 1 December 2023 |
| Primary completion | 1 September 2024 |
| Estimated completion | 1 October 2024 |
Drugs / interventions tested
- Prevora — full drug profile →
Conditions studied
- COPD (Chronic Obstructive Pulmonary Disease) — all drugs for COPD (Chronic Obstructive Pulmonary Disease) →
- CHF (Congestive Heart Failure) — all drugs for CHF (Congestive Heart Failure) →
- Dialysis — all drugs for Dialysis →
- Chronic Metabolic Disorder — all drugs for Chronic Metabolic Disorder →
Sponsor
CHX Technologies Inc. — full company profile →
Who can join
18 and older, any sex, with COPD (Chronic Obstructive Pulmonary Disease) or CHF (Congestive Heart Failure). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06158633
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- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06158633 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CHX Technologies Inc.
- Last refreshed: 4 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06158633.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing