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

NCT07555444 | Completed

• 1 other identifier: WECARE_oral_0001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Xerostomia; Salivary Flow; Artificial Saliva; Wecare Oral Care kit; ICU

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Oral comfort

  Baseline and 60 hours post-intervention.

• Oral health conditions

  Baseline and 60 hours post-intervention.

Study Arms (2)

Oral Care Kit

EXPERIMENTAL

Participants assigned to this group receive the Oral Care Kit every 12 hours after their hygiene routine for 60 hours.

Other: Oral Care Kit

Artificial Saliva

ACTIVE COMPARATOR

Participants assigned to this group receive Artificial Saliva every 12 hours after their hygiene routine.

Other: Artificial Saliva

Interventions

Oral Care Kit OTHER

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.

Oral Care Kit

Artificial Saliva OTHER

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.

Artificial Saliva

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• WECARE DESENVOLVIMENTO E COMERCIO DE MEDICAMENTOS E COSMETICOS LTDA: collaborator

Study Sites (1)

Albert Einstein Hospital Israelita

São Paulo, São Paulo, 05652-900, Brazil

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Saliva, Artificial

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Mouthwashes; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Fernanda de Paula Eduardo

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 29, 2026
• Study Start: October 25, 2022
• Primary Completion: October 11, 2025
• Study Completion: October 11, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)