Investigation of the Effect of Two Different Oral Care Methods on Oral Flora and Ventilator Associated Pneumonia in Mechanically Ventilated Patients: A Randomized Controlled Study
Phase: NA
Conditions: Ventilator Associated Pneumonia ( VAP)
Sponsor: Marmara University

 24/09/2025 
 
 
 
 
 
 
 
INVESTIGATION OF THE EFFECT OF TWO DIFFERENT ORAL CARE 
METHODS ON ORAL FLORA AND VENTILATOR ASSOCİATED PNEUMONIA IN 
MECHANİCALLY VENTİLATED PATIENTS:  
A RANDOMIZED CONTROLLED STUDY 
 
 
 
 
 
 
NCT ID not yet assigned 
 
 
 
 
 
 
 
 
 
 
 
 

1. Title 
The Effect of Two Different Oral Care Methods (Pediatric Toothbrush and Sponge Stick) 
on Oral Flora and Ventilator-Associated Pneumonia in Mechanically Ventilated ICU 
Patients: A Randomized Controlled Trial 
2. Acronym 
ORAVAP-RCT 
3. Background 
In critically ill patients receiving mechanical ventilation, the oral microflora changes within 
48 hours of intubation, with Gram-negative bacteria associated with nosocomial pneumonia 
replacing the normal Gram-positive flora (Miranda et al., 2016; Karateke ve Terzi, 2021). 
Ventilator-associated pneumonia (VAP) is associated with high mortality, prolonged 
hospital stays, increased antibiotic use, and healthcare costs (Ozveren., 2010). 
Although both sponge sticks and toothbrushes are widely used in the ICU settings for oral 
care, the comparative effectiveness of these methods in preventing VAP remains unclear. 
Establishing evidence-based oral care practices is critical for reducing infection risk and 
improving patient outcomes. 
4. Objectives and Hypotheses 
Objective: To compare the effects of two oral care methods (pediatric toothbrush vs sponge 
stick) on oral bacterial colonization and the incidence of VAP in mechanically ventilated 
ICU patients. 
Hypothesis: Oral care performed with a pediatric toothbrush is more effective than a 
sponge stick in reducing Gram-negative bacterial colonization and preventing the 
development of VAP. 
5.  Study Design 
Type: Randomized controlled trial 
      Model: Parallel assignment (2 arms) 
      Masking: Single-blind (independent outcome assessor) 
     Allocation: Randomized 
    6. Study Setting and Participants 
    The study will be conducted in the Anesthesia and General Intensive Care Unit of a hospital   
in Türkiye between October 2025 and June 2026. 
    Inclusion Criteria 
 
• 
Age ≥18 years, 
 
• 
Receiving invasive mechanical ventilation for less than 24 hours, 
 
• 
Informed consent obtained from legal guardian, 

 
• 
No history of oral/maxillofacial surgery or head/neck trauma, 
 
• 
No contraindications to oral care. 
 
Exclusion Criteria 
 
• 
Age <18 years, 
 
• 
Diagnosed pneumonia prior to intubation, 
 
• 
No informed consent, 
 
• 
Contraindications to oral care. 
7. Interventions 
Arm 1 (Experimental): Pediatric toothbrush + 0.12% chlorhexidine oral care set 
Arm 2 (Active Comparator): Sponge stick + 0.12% chlorhexidine oral care set 
Both groups will receive oral care for 5 consecutive days. 
8. Outcome Measures 
Primary Outcome 
Oral bacterial colonization (Staphylococcus spp., Pseudomonas spp., Acinetobacter spp.)  will 
be assessed by oral swabs on Day 1 and Day 6. 
Key Secondary Outcome 
Incidence of VAP – will be evaulated using the Clinical Pulmonary Infection Score (CPIS ≥6) 
during the Day 1 and Day 6. 
Additional Secondary Outcomes 
Frequency and quality of oral care as will be  measured by the Oral Care Assessment Scale for 
Intensive Care Patients developed by the researchers (daily assessments for 5 days). 
9. Sample Size 
Total: 72 patients (36 in pediatric toothbrush group, 36 in sponge stick group). 
Based on power analysis: 80% power, 5% alpha error to detect significant differences. 
10. Randomization and Masking 
Randomization will be performed using computer-based block randomization. 
Masking: Nurses providing oral care will not be blinded, but microbiology laboratory staff 
assessing bacterial cultures will remain blinded to group allocation. 
11. Data Collection and Measurements 
Introductory Information Form (baseline demographic and clinical data) 
Microbiology Patient Follow-up Form (oral swab results on Day 1 and Day 6) 

CPIS Patient Follow-up Form (VAP assessment on Day 1 and Day 6) 
Oral Care Assessment Scale (daily assessments for 5 days) 
12. Statistical Analysis Plan (SAP) 
Descriptive statistics (mean, SD, percentages). 
Between-group comparisons: Chi-square test, t-test/Mann–Whitney U test. 
Within-group changes: Repeated-measures ANOVA or Friedman test. 
Significance: p<0.05. 
Analysis approach: Intention-to-treat (ITT). 
13. Ethical Considerations 
Approved by the Koşuyolu High Specialization Training and Research Hospital Clinical 
Research Ethics Committee. 
Written informed consent will be obtained from the legal guardians of all patients. 
14. Timeline 
Data collection: October 2025 – June 2026 
Analysis: July-September 2026 
Publication: Late 2026 
15. References 
Miranda AL, et al. (2016). Oral care practices for patients in Intensive Care Units: A pilot 
survey. Indian J Crit Care Med, 20(5), 267-73. doi: 10.4103/0972-5229.182203. PMID: 
27275074; PMCID: PMC4876647. 
Karateke F, Terzi A. (2021). Investigation of ventilator-related pneumonıa (VAP) intensive care 
in Intensive Care Units, investigating the intervention of ventilator-related pneumonia: A 
systematıc revıew. Journal of Intensive Care Nursing, 25(1), 1-9. 
Ozveren H. (2010). Oral Care in Patients Receiving Mechanical Ventilator. Hacettepe 
University Faculty of Health Sciences Nursing Journal, 17(2), 92-99.