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

NCT07635225 | Completed

• 1 other identifier: E.521870
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patient Care in Intensive Care Units

Keywords

intensive care; intensive care nurse; nurse; oral care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oral mucosa assessment scale

  9:00 AM every day for 5 days

Study Arms (2)

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.

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.

Other: Routine oral care

Interventions

Oral care based on assessment scale OTHER

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

Individualized oral care frequency group

Routine oral care OTHER

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

Routine oral care group

Eligibility Criteria

• Age: 18 Months - 95 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balıkesir Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi

Balıkesir, Altıeylül, 10100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32633044 BACKGROUND

Study Officials

• türkan çalışkan

  Balıkesir Üniversitesi Sağlık Bilimleri Fakültesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Model Details: Study data was collected in two stages.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: June 9, 2026
• Study Start: August 20, 2025
• Primary Completion: October 20, 2025
• Study Completion: February 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 01/05/2026- 01/12/2027
• Access Criteria: It is accessible to everyone. They have access to data analysis and work plans.

Locations

TU (1)