A Comparative Study of Three Oral Care Methods in NIMV Patients in Intensive Care (NCT07200297) | Clinical Trial Compass
RecruitingNot Applicable
A Comparative Study of Three Oral Care Methods in NIMV Patients in Intensive Care
Turkey (Türkiye)60 participantsStarted 2025-09-15
Plain-language summary
This study aims to examine the effects of different oral care methods on oral health in patients receiving non-invasive mechanical ventilation (NIMV) in the intensive care unit. A randomized controlled experimental design will be employed, with three groups: Control Group - patients receiving only the standard chlorhexidine oral care kit; Electric Toothbrush Group - patients receiving the chlorhexidine kit in combination with an electric toothbrush and toothpaste; and Manual Toothbrush Group - patients receiving the chlorhexidine kit along with a manual toothbrush and toothpaste. Data collection tools will include the Patient Demographic Information Form, Oral Assessment Guide, saliva pH measurement, and salivation assessment using the Schirmer Tear Test Strip. The study is designed to compare the effects of different oral care methods on the oral health of patients receiving NIMV and to identify the most effective method.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must be in an intensive care unit
* Must have consented to participate in the study 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.
Exclusion Criteria:
* Intubated patients.
* Patients with severe oral infections or bleeding mucosal wounds.
* Those receiving radiotherapy/chemotherapy to the head and neck region.
* Organ transplant patients.
* Patients without oral anatomic abnormalities or dentures.
* Those who refused to participate in the study or did not sign the consent form.
* Patients with chronic or acute health conditions that prevent oral hygiene.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oral Health Status
Timeframe: From day 1 to day 3 (3 consecutive days).