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

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.

Study Overview

• Status: Completed
• Conditions: Xerostomia; Hyposalivation
• Intervention / Treatment: Other: Oral Care Kit; Other: Artificial Saliva

Detailed Description

Every 12 hours the participants will:

• Participants allocated to the Artificial Saliva group (Control): participants rinse with water (4 or 10 mL) for 30 seconds. Subsequently, a 2 g sachet of artificial saliva is applied, and participants are instructed to distribute the product across the entire oral mucosa using the tongue. After application, participants are advised to refrain from eating or drinking for 20 minutes and receive standardized oral care instructions from the Hospital Dentistry Team.
• Participants allocated to the Oral Care Kit group (Experimental): participants rinse with the Oral Care Kit mouthwash (5 or 10 mL) for 30 seconds. Subsequently, a 2 g sachet of the kit's oral gel is applied, and participants are instructed to distribute the product across the entire oral mucosa and teeth using the tongue. After application, participants are advised to refrain from eating or drinking for 20 minutes and receive standardized oral care instructions from the Hospital Dentistry Team.

All participants:

- Oral mucosa dryness assessment (at Baseline and 60 hours post-intervention): dryness of the oral mucosa is classified on a 0-4 scale, assessed visually under standardized lighting, with patients positioned supine and the bed inclined at 30-45°.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05652-900
      • Albert Einstein Hospital Israelita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• age between 18 and 69 years
• admission in ICU or SDU
• have at least four teeth present in the oral cavity
• show signs of dryness in the oral mucosa or lips

Exclusion criteria:

• participants admitted following scheduled surgery
• present infectious foci or lesions in the oral cavity
• have sustained trauma to the oral cavity
• have incomplete or inconsistent medical records
• are using any topical oral solution
• are unconscious
• are hospitalized due to COVID-19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Care Kit; Participants assigned to this group receive the Oral Care Kit every 12 hours after their hygiene routine for 60 hours.	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.
Active Comparator: Artificial Saliva; Participants assigned to this group receive Artificial Saliva every 12 hours after their hygiene routine.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of oral dryness	The degree of dryness of the oral mucosa is classified on a 0-4 scale, assessed visually under standardized lighting, with patients positioned supine and the bed inclined at 30-45°.	Baseline and 60 hours post-intervention.
Salivary volume	Unstimulated salivary volume (mL) is measured as the total saliva expectorated into a sterile tube over 3 minutes.	Baseline and 60 hours post-intervention.
Salivary flow rate	Salivary flow rate (mL/min) is calculated as the total unstimulated salivary volume collected over 3 minutes divided by the collection time.	Baseline and 60 hours post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral comfort	An oral comfort questionnaire is used. Domains related to general psychological well-being and social aspects of oral health, typically included in instruments such as the Oral Health Impact Profile-14 (OHIP-14), were not included because participants were admitted to the intensive care unit (ICU) or step-down unit (SDU), where these factors are inherently influenced by clinical status. To reduce cognitive load, a five-point visual Likert scale with schematic facial expressions was used to represent increasing levels of positivity (1-5 points). To minimize participant burden, the questionnaire was kept brief and comprised six domains. Total scores range from 6 to 30, with higher scores indicating better oral comfort.	Baseline and 60 hours post-intervention.
Oral health conditions	The participant's oral health condition is evaluated using the Bedside Oral Exam (BOE) scale, which comprises eight clinical criteria (swallowing, lips, tongue, saliva, mucous membranes, gums, teeth or dentures, and odor), each scored from 1 to 3. The total score ranges from 8 to 24 points, with 8 indicating good oral health and 24 representing severe dysfunction.	Baseline and 60 hours post-intervention.

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: WECARE DESENVOLVIMENTO E COMERCIO DE MEDICAMENTOS E COSMETICOS LTDA
• Investigators: Principal Investigator: Fernanda de Paula Eduardo, Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Actual): October 11, 2025
• Study Completion (Actual): October 11, 2025

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ICU; Xerostomia; Salivary Flow; Artificial Saliva; Wecare Oral Care kit
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Xerostomia; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Mouthwashes; Saliva, Artificial
• Other Study ID Numbers: WECARE_oral_0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns, as well as institutional and regulatory restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No