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

This study aims to investigate the effect of oral care frequency on oral mucosal tissue integrity in intensive care patients.

Study Overview

• Status: Completed
• Conditions: Patient Care in Intensive Care Units
• Intervention / Treatment: Other: Oral care based on assessment scale; Other: Routine oral care

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Altıeylül
    • Balıkesir, Altıeylül, Turkey (Türkiye), 10100
      • Balıkesir Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized oral care frequency group; Oral care is provided according to the Intensive Care Oral Care Frequency Assessment Scale score during the follow-up period.	Other: Oral care based on assessment scale; Oral care frequency is determined according to the Intensive Care Oral Care Frequency Assessment Scale.
Active Comparator: Routine oral care group; Oral care is provided according to routine unit practice, such as 4 times daily, during the follow-up period.	Other: Routine oral care; Oral care is provided according to standard intensive care unit routine practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	For 5 days after being admitted to intensive care

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9:00 AM every day for 5 days

Collaborators and Investigators

• Sponsor: Balikesir University
• Investigators: Study Director: türkan çalışkan, Balıkesir Üniversitesi Sağlık Bilimleri Fakültesi

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2025
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: intensive care; nurse; oral care; intensive care nurse
• Other Study ID Numbers: E.521870

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data collected, all individual participant data that forms the basis of the results in a publication.
• IPD Sharing Time Frame: 01/05/2026- 01/12/2027
• IPD Sharing Access Criteria: It is accessible to everyone. They have access to data analysis and work plans.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No