Active — Not RecruitingNot Applicable

Effect of Two Oral Care Methods on Oral Flora and VAP in Mechanically Ventilated Patients

Turkey (Türkiye)72 participantsStarted 2025-10-01

Plain-language summary

This randomized controlled trial aims to evaluate the effect of two oral care methods on oral bacterial colonization and ventilator-associated pneumonia (VAP) in mechanically ventilated intensive care unit (ICU) patients. The study will be conducted in the Anesthesia and General Intensive Care Unit of a hospital in Turkey between October 2025 and June 2026. A total of 72 patients who meet the inclusion criteria and provide informed consent will be randomly assigned to two groups. Thirty-six patients will receive oral care with a pediatric toothbrush, and 36 patients will receive oral care with a sponge stick, for five consecutive days. Standardized oral care sets containing 0.12% chlorhexidine, recommended for VAP prevention, will be used in both groups. Oral health and oral care frequency will be assessed daily using the "Oral Care Assessment Scale in Intensive Care Patients (OCAS-ICP)" developed by the researchers. Oral swabs will be collected on Day 1 and Day 6 and analyzed in the microbiology laboratory for colonization with Staphylococcus spp., Pseudomonas spp., and Acinetobacter spp. The Clinical Pulmonary Infection Score (CPIS) will be used to monitor the development of VAP, including six parameters: fever, leukocytes, tracheal secretions, oxygenation, chest radiography, and culture results. Patients will be evaluated on Days 1 and 6 for changes in oral flora and VAP occurrence. This study will provide evidence on the effectiveness of different oral care devices in preventing VAP and improving oral health in mechanically ventilated ICU patients.

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: * Patients who have been on invasive mechanical ventilation for less than 24 hours. * Patients who provide informed consent through their legal representative or themselves if capable. * Patients with no prior oral surgery, no head or neck trauma, and no contraindications to oral care. * Patients aged 18 years or older. Exclusion Criteria: * Patients under 18 years of age. * Patients who have been on mechanical ventilation for more than 24 hours before enrollment. * Patients with oral surgical procedures or trauma to the head or neck. * Patients with contraindications to oral care, such as severe oral bleeding, mucositis, or active oral infections. * Patients or legal representatives who do not provide informed consent.

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

Mean colony-forming unit (CFU) counts of oral bacterial colonization

Timeframe: Day 1 and Day 6

Incidence of ventilator-associated pneumonia based on the Clinical Pulmonary Infection Score (CPIS)

Timeframe: Day 1 and Day 6

Trial details

NCT IDNCT07283380

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Ventilator Associated Pneumonia ( VAP) trials