An interventional study of Chlorhexidine Mouth Rinse and Chlorhexidine Mouth Rinse De-Adoption in Mortality, Oral Health and Dryness, Mouth, sponsored by University of Toronto. Completed at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by University of Toronto · Not applicable, Interventional, and Prevention
Among 10 studies in Xerostomia with a site in Canada — none open to participants now, 1 under way, none of them phase 3. Xerostomia · Canada.
Among the 10 studies in Xerostomia with a site in Canada, this one is one of 2 that started in 2017, is one of 2 with no phase, and was the 8th registered.
286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.
Browse Xerostomia studies →None of the 10 studies in Xerostomia with a site in Canada is open now. The open studies under Xerostomia, anywhere →
Of the 26 Xerostomia studies recruiting now, 15 (58%) set no upper age limit and 7 (27%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 2 · Phase 4 1
First in 2000; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3,260 is above the median of 44 across 235 interventional studies indexed under Xerostomia.
Median enrollment 132 across the 7 interventional studies, 100 across the 3 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.
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2 of 10 have an industry lead sponsor. The 8 most frequent:
University of Toronto is the lead sponsor of 404 studies on the registry; 55 are open to participants now.
University of Toronto has 1 study filed under Xerostomia — fewer than ten, so there is no comparison to draw.
1 of the studies in Xerostomia with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05060341MeiraGTx, LLCLong-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia | 2027-03 |
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Among the 10 studies in Xerostomia with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The objective of the CHORAL study is to evaluate the de-adoption of oral chlorhexidine and the introduction of a bundle of oral care practices on selected outcomes in critically ill mechanically ventilated adults.
Infrequent or ineffective oral care can lead to mouth discomfort and lung infection for patients treated with ventilators (breathing machines) in intensive care units (ICUs). A commonly used mouthwash called chlorhexidine can reduce lung infection but most recent evidence shows it may increase the risk of death. In this study 6 participating intensive care units (ICUs) will de-adopt oral chlorhexidine and introduce a bundle of oral care practices using a multi-faceted educational tool kit. The investigators will measure changes in patient-oriented outcomes including mortality, ventilator-associated complications (VACs) and oral health status. A concurrent process evaluation will study how the intervention is delivered and received by patients and clinicians..
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Application of chlorhexidine gluconate mouth rinse per unit protocol.
Other: Chlorhexidine Mouth Rinse
No application of chlorhexidine gluconate mouth rinse. Oral care bundle.
Other: Chlorhexidine Mouth Rinse De-Adoption
Oral chlorhexidine gluconate oral rinse
Also known as: Chlorhexidine
Multifaceted education and audit/feedback.
Also known as: De-adopt chlorhexidine
Intensive Care Unit (ICU) Mortality
All-cause mortality at time of ICU discharge
Time frame: 14 months
Infection-related ventilator-associated complications (IVACs)
Changes in IVACs rates between groups
Time frame: 14 months
Beck Oral Assessment Score (BOAS), Modified
Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction).
Time frame: 14 months
Critical Care Pain Observational Tool (CPOT)
Changes in oropharyngeal pain between groups. CPOT scores range from 0-8 with a score \>2 indicating presence of pain.
Time frame: 14 months
Oral Dryness - Numeric Rating Intensity Scale (NRS)
Changes in oral dryness scores between groups. NRS scores range from 0 (no dryness) to 10 (severe dryness).
Time frame: 14 months
Plan to share: No
Ran from Dec 2017 to primary completion in Jan 2019, 13 months.
Of 85 non-industry interventional studies with no phase under Xerostomia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's 13 months is below that.
Counting every sponsor, half of 101 studies reached it within 13 months; a quarter within 4 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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