XerostomiaNCT07555444
Evaluation of an Oral Care Kit for Maintaining the Oral Health of Patients Admitted to the Intensive Care Unit
A study testing Oral Care Kit and Artificial Saliva in people with Xerostomia and Hyposalivation, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Xerostomia, Hyposalivation
- What is being tested?
- Oral Care Kit and Artificial Saliva
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Oct 2022to 11 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Albert Einstein Hospital Israelita
São Paulo, São Paulo, 05652-900
About this study
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?
Read more
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.
Read the 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°.
- Conditions
- Xerostomia, Hyposalivation
- Being tested
- Oral Care Kit, Artificial Saliva
- Keywords
- Xerostomia, Salivary Flow, Artificial Saliva, Wecare Oral Care kit, ICU
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Care KitOther
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 SalivaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Care Kit | Experimental | Participants assigned to this group receive the Oral Care Kit every 12 hours after their hygiene routine for 60 hours. Receives: Other: Oral Care Kit |
| Artificial Saliva | Active comparator | Participants assigned to this group receive Artificial Saliva every 12 hours after their hygiene routine. Receives: Other: Artificial Saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
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°.
Measured: 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.
Measured: 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.
Measured: Baseline and 60 hours post-intervention.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 60 hours post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start25 Oct 2022
- Primary completion11 Oct 2025
- Study completion11 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- WECARE DESENVOLVIMENTO E COMERCIO DE MEDICAMENTOS E COSMETICOS LTDA
- Responsible party
- Sponsor
- Investigators
- Fernanda de Paula Eduardo, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555444
- Sponsor's protocol ID
- WECARE_oral_0001
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns, as well as institutional and regulatory restrictions.
Publications
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.
PubMed 42416311
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oral Care Kit for Maintaining the Oral Health of Patients Admitted to the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07555444
- Acronym / sponsor ID
- WECARE_oral_0001
- Conditions
- Xerostomia, Hyposalivation
- Keywords
- Xerostomia, Salivary Flow, Artificial Saliva, Wecare Oral Care kit, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- WECARE DESENVOLVIMENTO E COMERCIO DE MEDICAMENTOS E COSMETICOS LTDA
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 11 Oct 2025 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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°.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Care Kit | Experimental | Other: Oral Care KitParticipants assigned to this group receive the Oral Care Kit every 12 hours after their hygiene routine for 60 hours. |
| Artificial Saliva | Active comparator | Other: Artificial SalivaParticipants assigned to this group receive Artificial Saliva every 12 hours after their hygiene routine. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Care KitEvery 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. | Other | Oral Care Kit |
| Artificial SalivaEvery 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. | Other | Artificial Saliva |
Primary outcome
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°.
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.
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.
2 secondary outcomes
Oral comfort
Time frame: Baseline and 60 hours post-intervention.
Oral health conditions
Time frame: Baseline and 60 hours post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 42416311Bezinelli 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda de Paula Eduardo principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Care Kit and Artificial Saliva in people with Xerostomia and Hyposalivation, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of oral dryness (time frame: Baseline and 60 hours post-intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07555444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.