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

NCT07555444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Xerostomia
  • Hyposalivation

Interventions

OTHER

Oral Care Kit

Every 12 hours for 60 hours, participants follow a standardized oral hygiene routine: rinse with the Oral Care Kit mouthwash (5 or 10 mL) for 30 seconds, then apply a 2 g sachet of the oral gel, which is distributed across the entire oral mucosa and teeth. After application, participants are instructed to refrain from eating or drinking for 20 minutes and receive standardized oral care instructions from the Hospital Dentistry Team.

OTHER

Artificial Saliva

Every 12 hours for 60 hours, participants follow a standardized oral hygiene routine: they rinse with water (4 or 10 mL) for 30 seconds, then apply a 2 g sachet of artificial saliva, distributing it across the entire oral mucosa using the tongue. After application, participants are instructed to refrain from eating or drinking for 20 minutes and receive standardized oral care instructions from the Hospital Dentistry Team.

Sponsors & Collaborators

  • WECARE DESENVOLVIMENTO E COMERCIO DE MEDICAMENTOS E COSMETICOS LTDA

    collaborator UNKNOWN

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Fernanda de Paula Eduardo · Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2025-10-11
Completion
2025-10-11

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07555444 on ClinicalTrials.gov