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Completed

NCT Number: NCT07555444

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.

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Key information

Conditions

Xerostomia Hyposalivation Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein Hospital Israelita

São Paulo, 05652-900, Brazil

About this study

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°.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Degree of oral dryness

    Time frame: Baseline and 60 hours post-intervention.

    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°.

  2. Salivary volume

    Time frame: Baseline and 60 hours post-intervention.

    Unstimulated salivary volume (mL) is measured as the total saliva expectorated into a sterile tube over 3 minutes.

  3. Salivary flow rate

    Time frame: Baseline and 60 hours post-intervention.

    Salivary flow rate (mL/min) is calculated as the total unstimulated salivary volume collected over 3 minutes divided by the collection time.

Secondary outcomes

  1. Oral comfort

    Time frame: Baseline and 60 hours post-intervention.

    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.

  2. Oral health conditions

    Time frame: Baseline and 60 hours post-intervention.

    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.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • WECARE DESENVOLVIMENTO E COMERCIO DE MEDICAMENTOS E COSMETICOS LTDA

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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