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Completed

NCT Number: NCT07635225

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

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

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Key information

Age range

18 month–95 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balıkesir Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi

Balıkesir, Altıeylül, 10100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral care based on assessment scale

Other

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

Routine oral care

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Oral mucosa assessment scale

    Time frame: 9:00 AM every day for 5 days

    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.

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Acronym: oral care

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.