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Investigating the Effect of Oral Care Frequency on Oral Mucosal Tissue Integrity in Critically Ill Patients.

Investigating the Effect of Oral Care Frequency on Oral Mucosal Tissue Integrity in Critically Ill Patients.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07635225
Acronym
oral care
Enrollment
50
Registered
2026-06-09
Start date
2025-08-20
Completion date
2026-02-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Care in Intensive Care Units

Keywords

intensive care, intensive care nurse, nurse, oral care

Brief summary

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.

Interventions

OTHEROral care based on assessment scale

Oral care frequency is determined according to the Intensive Care Oral Care Frequency Assessment Scale.

Oral care is provided according to standard intensive care unit routine practice.

Sponsors

Balikesir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

Study data was collected in two stages.

Eligibility

Sex/Gender
ALL
Age
18 Months to 95 Months
Healthy volunteers
No

Inclusion criteria

* •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.

Exclusion criteria

* • 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.

Design outcomes

Primary

MeasureTime frameDescription
Intensive Care Unit Oral Care Frequency Assessment Scale (Day 1 to Day 5)For 5 days after being admitted to intensive care9 points 12\*1 10-19 points 3\*1 20-29 points 4\*1 30 and above 6\*1

Secondary

MeasureTime frameDescription
Oral mucosa assessment scale9:00 AM every day for 5 daysThe 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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORtürkan çalışkan

Balıkesir Üniversitesi Sağlık Bilimleri Fakültesi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026