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| Name | Class |
|---|---|
| WECARE DESENVOLVIMENTO E COMERCIO DE MEDICAMENTOS E COSMETICOS LTDA | UNKNOWN |
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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:
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:
Every 12 hours the participants will:
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°.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Care Kit | Experimental | Participants assigned to this group receive the Oral Care Kit every 12 hours after their hygiene routine for 60 hours. |
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| Artificial Saliva | Active Comparator | Participants assigned to this group receive Artificial Saliva every 12 hours after their hygiene routine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernanda de Paula Eduardo | Hospital Israelita Albert Einstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein Hospital Israelita | São Paulo | São Paulo | 05652-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42416311 | Derived | Bezinelli LM, Gobbi MF, Campos GVC, Andrade-Silva J, Monnaka VU, Eduardo FP. WeCare oral kit outperforms artificial saliva in salivary flow and oral health. Front Oral Health. 2026 Jun 23;7:1869907. doi: 10.3389/froh.2026.1869907. eCollection 2026. |
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Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns, as well as institutional and regulatory restrictions.
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012464 | Saliva, Artificial |
| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| 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. |
|
| 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. |