Clinical Trial

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

Study acronym: ORAVAP-RCT
Active, Not Recruiting
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Record status
This record was last updated December 15, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07283380
Lead Sponsor Marmara University
Conditions Ventilator Associated Pneumonia ( VAP)
Enrollment 72 participants
Start Date 2025-10-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-15