Hyposalivation, Xerostomia
Conditions
Keywords
Xerostomia, Salivary Flow, Artificial Saliva, Wecare Oral Care kit, ICU
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.
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°.
Interventions
OTHEROral 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.
OTHERArtificial 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
Hospital Israelita Albert Einstein
WECARE DESENVOLVIMENTO E COMERCIO DE MEDICAMENTOS E COSMETICOS LTDA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of oral dryness | 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°. |
| Salivary volume | Baseline and 60 hours post-intervention. | Unstimulated salivary volume (mL) is measured as the total saliva expectorated into a sterile tube over 3 minutes. |
| Salivary flow rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Oral comfort | 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. |
| Oral health conditions | 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. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORFernanda de Paula Eduardo
Hospital Israelita Albert Einstein
Outcome results
None listed