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

NCT07283380 | Active Not Recruiting

• 1 other identifier: AYDIN-VAP-2025-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ventilator Associated Pneumonia ( VAP)

Keywords

Oral Care; Oral Bacterial Colonization; Mechanically Ventilated Patients

Outcome Measures

Primary Outcomes (2)

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

  Oral swabs are collected from patients on Day 1 and Day 6 and analyzed in the microbiology laboratory to determine the mean CFU counts of Staphylococcus spp., Pseudomonas spp., and Acinetobacter spp. to assess oral bacterial colonization

  Day 1 and Day 6

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

  To monitor the development of ventilator-associated pneumonia, the Clinical Pulmonary Infection Score (CPIS) will be used. This scoring system includes six parameters: body temperature, leukocyte count, tracheal secretions, oxygenation (PaO₂/FiO₂), chest radiograph findings, and microbiological culture results. The total CPIS ranges from 0 to 12, with higher scores indicating worse pulmonary infection and a higher likelihood of ventilator-associated pneumonia. A CPIS score above 6 has been reported to be highly reliable for diagnosing pneumonia, with 93% sensitivity and 100% specificity.

  Day 1 and Day 6

Secondary Outcomes (1)

• Oral care frequency assessed by the Oral Care Assessment Scale for Intensive Care Patients (OCAS-ICP)

  Day 1 to Day 6

Study Arms (2)

Pediatric toothbrush group

EXPERIMENTAL

Patients will receive oral care with a pediatric toothbrush for 5 days. Oral swabs and CPIS scores will be monitored.

Device: Pediatric toothbrush

Sponge stick group

ACTIVE COMPARATOR

Patients will receive oral care with a sponge stick for 5 days. Oral swabs and CPIS scores will be monitored.

Device: Sponge stick

Interventions

Pediatric toothbrush DEVICE

Oral care will be using a pediatric toothbrush for 5 days; oral swabs and CPIS scores will be monitored.

Pediatric toothbrush group

Sponge stick DEVICE

Oral care will be using a sponge stick for 5 days; oral swabs and CPIS scores will be monitored.

Sponge stick group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Zonguldak Ataturk State Hospital

Zonguldak, 67000, Turkey (Türkiye)

Location

Zonguldak Atatürk State Hospital, Ministry of Health, Türkiye

Zonguldak, 67000, Turkey (Türkiye)

Location

Related Publications (3)

• Diaconu O, Siriopol I, Polosanu LI, Grigoras I. Endotracheal Tube Biofilm and its Impact on the Pathogenesis of Ventilator-Associated Pneumonia. J Crit Care Med (Targu Mures). 2018 Apr 1;4(2):50-55. doi: 10.2478/jccm-2018-0011. eCollection 2018 Apr.

  PMID: 30581995 RESULT

• Miranda AF, de Paula RM, de Castro Piau CG, Costa PP, Bezerra AC. Oral care practices for patients in Intensive Care Units: A pilot survey. Indian J Crit Care Med. 2016 May;20(5):267-73. doi: 10.4103/0972-5229.182203.

  PMID: 27275074 RESULT

• Terezakis E, Needleman I, Kumar N, Moles D, Agudo E. The impact of hospitalization on oral health: a systematic review. J Clin Periodontol. 2011 Jul;38(7):628-36. doi: 10.1111/j.1600-051X.2011.01727.x. Epub 2011 Apr 7.

  PMID: 21470276 RESULT

Related Links

• Endotracheal Tube Biofilm and its Impact on the Pathogenesis of Ventilator-Associated Pneumonia
• Oral care practices for patients in Intensive Care Units: A pilot survey
• The impact of hospitalization on oral health: a systematic review

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gulten OKUROĞLU, Assoc.Prof

  Marmara University

  PRINCIPAL INVESTIGATOR

• Ayse AYDIN, PhDCand.

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking: Single-blind (independent outcome assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: "Patients will be randomly assigned to one of two parallel groups. One group will receive oral care using a pediatric toothbrush, and the other group will receive oral care using a sponge stick. Each patient will receive only the assigned intervention for 5 consecutive days in the intensive care unit. Oral assessments and microbiological samples will be collected to evaluate changes in oral bacterial colonization and the development of ventilator-associated pneumonia (VAP).

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)