Clinical Trial

Evaluation of an Oral Care Kit for Maintaining the Oral Health of Patients Admitted to the Intensive Care Unit

Completed
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Summary
The goal of this randomized clinical trial is to evaluate the efficacy of the Oral Care Kit, developed by Wecare, in reducing oral mucosal dryness and preventing oral ulcers in patients admitted to the ICU or step-down unit. The main questions it aims to answer are: * Does the use of the Oral Care Kit reduce mouth dryness compared to standard treatment (artificial saliva)? * Does the use of the Oral Care Kit change salivary volume and flow compared to standard treatment (artificial saliva)? * Does the use of the Oral Care Kit alter the oral health condition of the participants? Researchers will compare the use of the Oral Care Kit with artificial saliva care to see whether it reduces mouth dryness and improves patients' oral health. Participants will: * Use the Oral Care Kit or artificial saliva every 12 hours for 60 hours after their oral hygiene routine with daily toothbrushing with fluoridated toothpaste. * Have their mouth dryness, salivary flow rate, oral health conditions, and oral comfort assessed at Baseline and after 60 hours of intervention.
Trial Details
NCT Number NCT07555444
Lead Sponsor Hospital Israelita Albert Einstein
Collaborators: WECARE DESENVOLVIMENTO E COMERCIO DE MEDICAMENTOS E COSMETICOS LTDA
Conditions Xerostomia, Hyposalivation
Enrollment 82 participants
Start Date 2022-10-25
Primary Completion 2025-10-11 (estimated)
Study Completion 2025-10-11 (estimated)
Updated on ClinicalTrials.gov 2026-04-29