Comparing three oral care methods for ICU patients on non-invasive ventilation
Comparison of Three Different Oral Care Methods in Terms of Oral Health in Intensive Care Patients Receiving Non-Invasive Mechanical Ventilation: A Randomized Controlled Trial
This study will try three oral care routines—standard chlorhexidine alone, chlorhexidine with an electric toothbrush, or chlorhexidine with a manual toothbrush—for adults on non-invasive ventilation in the ICU to see which keeps the mouth healthiest.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ataturk University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Erzurum, Merkez) |
| Trial ID | NCT07200297 on ClinicalTrials.gov |
What this trial studies
This randomized controlled experiment will enroll adult ICU patients receiving non-invasive mechanical ventilation and assign them to one of three oral care groups: standard chlorhexidine alone, chlorhexidine plus an electric toothbrush and toothpaste, or chlorhexidine plus a manual toothbrush and toothpaste. Oral health will be measured using a demographic form, an Oral Assessment Guide, saliva pH testing, and salivation measurement with Schirmer Tear Test Strips. Participants must be conscious, able to communicate, free of active infection, and expected to remain in the ICU at least 48 hours. The study compares outcomes across groups to identify which combination most effectively maintains or improves oral health in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults in the intensive care unit who are on non-invasive mechanical ventilation, are conscious and able to communicate, have consented to participate, and are expected to remain in ICU for at least 48 hours.
Not a fit: Patients who are intubated, have severe oral infections or bleeding mucosal wounds, have had head/neck radiotherapy or chemotherapy, are organ transplant recipients, or have other conditions that prevent safe oral hygiene are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the preferred oral care method could reduce oral complications and improve comfort for ICU patients on non-invasive ventilation, potentially lowering downstream infection risk and care needs.
How similar studies have performed: Related ICU oral-care studies using chlorhexidine and toothbrushing have shown mixed but sometimes promising improvements in oral outcomes, while direct comparisons of electric versus manual toothbrushes in non-invasive ventilation patients remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Erzurum, Merkez
- Ataturk University — Erzurum, Merkez, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Reva PROF.DR — https://avesis.atauni.edu.tr/reva
- Study coordinator: Sümeyye BİLGİLİ TEKİN
- Email: smeyyebilgili@gmail.com
- Phone: 0506 175 93 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.