Actively Recruiting
Comparison of Three Different Oral Care Methods in Intensive Care Patients Receiving Non-Invasive Mechanical Ventilation: A Randomized Controlled Trial
Led by SÜMEYYE BİLGİLİ TEKİN · Updated on 2025-10-01
60
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
S
SÜMEYYE BİLGİLİ TEKİN
Lead Sponsor
A
Ataturk University
Collaborating Sponsor
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 SÜMEYYE BİLGİLİ TEKİN 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 consecutive days
Participants receive one of three oral care methods while on non-invasive mechanical ventilation in intensive care: standard chlorhexidine oral care, electric toothbrush with toothpaste and chlorhexidine, or manual toothbrush with toothpaste and chlorhexidine.
Daily visits for 3 days
Trial Site Locations
Total: 1 location
1
Ataturk University
Erzurum, Merkez, Turkey (Türkiye), 25240
Actively Recruiting
Research Team
S
Sümeyye BİLGİLİ TEKİN
B
BAHAR DOÇ.DR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here