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

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.

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°.

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