What is this study trying to find out about oral complications in intensive care patients?

This study is evaluating the effects of different oral care methods on oral health in patients receiving non-invasive mechanical ventilation in intensive care. Researchers aim to identify which oral care method best supports oral health. The study is led by SÜMEYYE BİLGİLİ TEKİN and uses a randomized controlled design for comparison.

Who may be eligible for this oral complication clinical trial?

Adults 18 years or older who are in intensive care and receiving non-invasive mechanical ventilation may be eligible. Participants must be conscious, able to communicate, free from active infections, and expected to stay in intensive care for at least 48 hours. Please review eligibility criteria for more details.

Is there any cost to participate in this oral complication clinical trial?

Study-related care, including the oral care methods and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered. Participants can expect to receive all treatments and assessments without charge.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07200297

Comparing Three Oral Care Methods for Patients on Non-Invasive Mechanical Ventilation in Intensive Care

Led by SÜMEYYE BİLGİLİ TEKİN · Updated on 2025-10-01

Participants Needed

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of different oral care methods on oral health in patients receiving non-invasive mechanical ventilation NIMV in the intensive care unit. This randomized controlled trial compares three groups to find the most effective oral care method. The study is led by SMEYYE BLGL TEKN and focuses on preventing oral complications in these patients. Participants will be randomly assigned to one of three groups a control group receiving the standard chlorhexidine oral care kit an electric toothbrush group receiving the chlorhexidine kit plus an electric toothbrush and toothpaste and a manual toothbrush group receiving the chlorhexidine kit with a manual toothbrush and toothpaste. Treatments are given during the intensive care stay while patients are on NIMV. During the study, participants oral health will be assessed daily for three consecutive days using tools like the Oral Assessment Guide, saliva pH measurements, and salivation tests with Schirmer Tear Test Strips. Researchers will monitor oral health status and saliva pH to evaluate the effects of the different oral care methods. The study starts September 2025 and runs through April 2026.

CONDITIONS

Brief Title

A Comparative Study of Three Oral Care Methods in NIMV Patients in Intensive Care

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Must be in an intensive care unit
Must have consented to participate from themselves or their family
Must be over 18 years of age
Must be on a non-invasive mechanical ventilator
Must have no known active infection
Must be in a stable state of consciousness and able to communicate
Must be expected to remain in intensive care for at least 48 hours

You will not qualify if you...

Intubated patients
Patients with severe oral infections or bleeding mucosal wounds
Those receiving radiotherapy or chemotherapy to the head and neck region
Organ transplant patients
Patients without oral anatomic abnormalities or dentures
Those who refused to participate or did not sign the consent form
Patients with chronic or acute health conditions that prevent oral hygiene

Research Team

Sümeyye BİLGİLİ TEKİN

BAHAR DOÇ.DR

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