Patient Care in Intensive Care Unitsoral careNCT07635225
Investigating the Effect of Oral Care Frequency on Oral Mucosal Tissue Integrity in Critically Ill Patients.
A study testing Oral care based on assessment scale and Routine oral care in people with Patient Care in Intensive Care Units, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of oral care frequency on oral mucosal tissue integrity in intensive care patients. Read more about this study
- Who is it for?
- Ages 18 to 95 months
- Conditions the study is for
- Patient Care in Intensive Care Units
- What is being tested?
- Oral care based on assessment scale and Routine oral care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2025to 1 Feb 2026
- 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 95 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- •Patients admitted to the adult intensive care unit:
- Patients aged 18 and over
- Patients who agreed to participate in the study (voluntary informed consent obtained from the patient or their relatives)
- Patients who are not allergic to the contents of the oral care solution to be used were included in the study.
Who cannot join
- • Patients under 18 years of age
- Patients with oral bleeding
- Patients with thrombocytopenia
- Patients who have undergone oral surgery
- Patients who did not consent to the study (either from the patient themselves or a relative) were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balıkesir Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
Balıkesir, Altıeylül, 10100
About this study
This study aims to investigate the effect of oral care frequency on oral mucosal tissue integrity in intensive care patients.
Read the detailed description
Research data will be collected from the Adult Intensive Care Units of Balıkesir University Health Practice and Research Hospital. Patients meeting the inclusion criteria will be informed about the research, and those who volunteer to participate, or their relatives, will provide written/verbal consent using an Informed Consent Form. The assignment of patients to different groups will be determined using simple randomization on the randomizer.org website. Patients admitted to the intensive care unit at the start of the study will be assigned to control and intervention groups according to the numbers on the randomizer.org website. Oral care swabs will be prepared for each patient in both the control and intervention groups, with four swabs per patient, moistened with a 0.25% chlorhexidine gluconate solution. If the patient is conscious, they will be placed in a comfortable position; if unconscious, their head will be positioned sideways towards the person performing the procedure. Oral care will be performed on the patient, covering all teeth, inner cheeks, under the tongue, gums, and other soft tissues. After the patient's oral care procedure is complete, the patient will be returned to their original position, and the procedure will be finished. Each care session will last at least 2 minutes. Patients in the control group will receive oral care four times a day, every six hours. Patients in the intervention group will receive oral care at a frequency determined individually based on their scores on the intensive care oral care frequency assessment scale. Patients in both groups will be evaluated at the beginning and throughout the intervention using the oral mucosa assessment scale to assess the effect of the oral care on the oral mucosa. The intervention is planned to continue for five days, and the results will be recorded.
- Conditions
- Patient Care in Intensive Care Units
- Being tested
- Oral care based on assessment scale, Routine oral care
- Keywords
- intensive care, intensive care nurse, nurse, oral care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral care based on assessment scaleOther
Oral care frequency is determined according to the Intensive Care Oral Care Frequency Assessment Scale.
Routine oral careOther
Oral care is provided according to standard intensive care unit routine practice.
| Study group | Role | What they receive |
|---|---|---|
| Individualized oral care frequency group | Experimental | Oral care is provided according to the Intensive Care Oral Care Frequency Assessment Scale score during the follow-up period. Receives: Other: Oral care based on assessment scale |
| Routine oral care group | Active comparator | Oral care is provided according to routine unit practice, such as 4 times daily, during the follow-up period. Receives: Other: Routine oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care Unit Oral Care Frequency Assessment Scale (Day 1 to Day 5)
9 points 12*1 10-19 points 3*1 20-29 points 4*1 30 and above 6*1
Measured: For 5 days after being admitted to intensive care
Secondary outcomes (1)
Oral mucosa assessment scale
The scale evaluates five sections of the mouth and its parts (lips, oral mucosa, gingiva, tongue, teeth, and saliva). Each question is scored from 1 to 4. The lowest possible score is "5" and the highest is "20". A score of 0-5 indicates normal oral mucosal health, 6-20 indicates mild dysfunction, 11-15 indicates moderate dysfunction, and 16-20 indicates severe dysfunction. A low score indicates good oral mucosal health, while a high score indicates poor oral mucosal health.
Measured: 9:00 AM every day for 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start20 Aug 2025
- Primary completion20 Oct 2025
- Study completion1 Feb 2026
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 Patient Care in Intensive Care UnitsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study data was collected in two stages.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, berat fidan, Balikesir University
- Investigators
- türkan çalışkan, Study director, Balıkesir Üniversitesi Sağlık Bilimleri Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635225
- Sponsor's protocol ID
- E.521870
- Acronym
- oral care
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected, all individual participant data that forms the basis of the results in a publication.
Publications
Dogu Kokcu O, Terzi B. Development of an intensive care oral care frequency assessment scale. Nurs Crit Care. 2022 Sep;27(5):667-675. doi: 10.1111/nicc.12529. Epub 2020 Jul 6.
PubMed 32633044
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Oral Care Frequency on Oral Mucosal Tissue Integrity in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT07635225
- Acronym / sponsor ID
- oral care / E.521870
- Conditions
- Patient Care in Intensive Care Units
- Keywords
- intensive care, intensive care nurse, nurse, oral care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 9 Jun 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.
This study aims to investigate the effect of oral care frequency on oral mucosal tissue integrity in intensive care patients.
Detailed description
Research data will be collected from the Adult Intensive Care Units of Balıkesir University Health Practice and Research Hospital. Patients meeting the inclusion criteria will be informed about the research, and those who volunteer to participate, or their relatives, will provide written/verbal consent using an Informed Consent Form. The assignment of patients to different groups will be determined using simple randomization on the randomizer.org website. Patients admitted to the intensive care unit at the start of the study will be assigned to control and intervention groups according to the numbers on the randomizer.org website. Oral care swabs will be prepared for each patient in both the control and intervention groups, with four swabs per patient, moistened with a 0.25% chlorhexidine gluconate solution. If the patient is conscious, they will be placed in a comfortable position; if unconscious, their head will be positioned sideways towards the person performing the procedure. Oral care will be performed on the patient, covering all teeth, inner cheeks, under the tongue, gums, and other soft tissues. After the patient's oral care procedure is complete, the patient will be returned to their original position, and the procedure will be finished. Each care session will last at least 2 minutes. Patients in the control group will receive oral care four times a day, every six hours. Patients in the intervention group will receive oral care at a frequency determined individually based on their scores on the intensive care oral care frequency assessment scale. Patients in both groups will be evaluated at the beginning and throughout the intervention using the oral mucosa assessment scale to assess the effect of the oral care on the oral mucosa. The intervention is planned to continue for five days, and the results will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study data was collected in two stages.
| Arm | Type | Receives |
|---|---|---|
| Individualized oral care frequency group | Experimental | Other: Oral care based on assessment scaleOral care is provided according to the Intensive Care Oral Care Frequency Assessment Scale score during the follow-up period. |
| Routine oral care group | Active comparator | Other: Routine oral careOral care is provided according to routine unit practice, such as 4 times daily, during the follow-up period. |
Who may qualify
- Ages
- 18 to 95 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- •Patients admitted to the adult intensive care unit:
Key exclusion criteria (5 listed)
- • Patients under 18 years of age
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 based on assessment scaleOral care frequency is determined according to the Intensive Care Oral Care Frequency Assessment Scale. | Other | Individualized oral care frequency group |
| Routine oral careOral care is provided according to standard intensive care unit routine practice. | Other | Routine oral care group |
Primary outcome
Intensive Care Unit Oral Care Frequency Assessment Scale (Day 1 to Day 5)
Time frame: For 5 days after being admitted to intensive care
9 points 12*1 10-19 points 3*1 20-29 points 4*1 30 and above 6*1
1 secondary outcome
Oral mucosa assessment scale
Time frame: 9:00 AM every day for 5 days
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 9 Jun 2026.
- Background: PubMed 32633044Dogu Kokcu O, Terzi B. Development of an intensive care oral care frequency assessment scale. Nurs Crit Care. 2022 Sep;27(5):667-675. doi: 10.1111/nicc.12529. Epub 2020 Jul 6.
- Individual participant dataSharing planned: Yes. All individual participant data collected, all individual participant data that forms the basis of the results in a publication.
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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.
türkan çalışkan study director
Balıkesir Üniversitesi Sağlık Bilimleri Fakültesi
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 based on assessment scale and Routine oral care in people with Patient Care in Intensive Care Units, run by Balikesir University at 1 site in Turkey (Türkiye).
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 5 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 9 Jun 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 Turkey (Türkiye). 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?
Intensive Care Unit Oral Care Frequency Assessment Scale (Day 1 to Day 5) (time frame: For 5 days after being admitted to intensive care). 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 NCT07635225, 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 9 Jun 2026.