Pediatric toothbrush
DeviceOral care will be using a pediatric toothbrush for 5 days; oral swabs and CPIS scores will be monitored.
NCT Number: NCT07283380
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Zonguldak Ataturk State Hospital, Zonguldak, Turkey (Türkiye)
This study is designed as a randomized controlled trial to evaluate the effect of two different oral care methods on oral bacterial colonization and the incidence of ventilator-associated pneumonia (VAP) in mechanically ventilated patients in the intensive care unit (ICU). The two methods to be compared are oral care performed with a pediatric toothbrush and oral care performed with a sponge stick.
The study population will consist of patients receiving respiratory support with mechanical ventilation 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 included. Patients will be randomly assigned to one of two groups: 36 patients will receive oral care using a pediatric toothbrush, and 36 patients will receive oral care using a sponge stick, for a period of 5 consecutive days. In both groups, standardized oral care sets containing 0.12% chlorhexidine, a solution recommended for the prevention of VAP, will be used.
Oral assessments and the frequency of oral care are important for effective nursing practices in the ICU. However, there is currently no validated measurement tool in the national or international literature that evaluates both oral and clinical conditions in this patient population. For this reason, the "Oral Care Assessment Scale in Intensive Care Patients (OCAS-ICP)" developed by the researchers, will be applied daily for 5 days to assess the oral health status and oral care needs of patients.
Oral swab samples will be collected from patients on Day 1 (baseline) and Day 6 of the study and evaluated in the microbiology laboratory. The analysis will focus on colonization with bacterial species associated with VAP, specifically Staphylococcus spp., Pseudomonas spp., and Acinetobacter spp. Results will be recorded on the "Microbiology Patient Follow-up Form."
To monitor the development of VAP, the Clinical Pulmonary Infection Score (CPIS) will be used. This scoring system includes six parameters: fever, leukocyte count, tracheal secretions, oxygenation, chest radiograph findings, and culture results. It has been reported that a CPIS score above 6 is highly reliable for diagnosing pneumonia, with 93% sensitivity and 100% specificity. CPIS data will be collected using the "Clinical Pulmonary Infection Score Patient Follow-up Form" within the first 24 hours of ICU admission and during follow-up.
The primary outcomes will be the change in oral bacterial flora and the incidence of VAP between the two study groups. The findings are expected to provide evidence on the effectiveness of different oral care devices in preventing VAP and improving oral health in mechanically ventilated patients in the ICU.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral care will be using a pediatric toothbrush for 5 days; oral swabs and CPIS scores will be monitored.
Oral care will be using a sponge stick for 5 days; oral swabs and CPIS scores will be monitored.
Time frame: Day 1 and Day 6
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
Time frame: Day 1 and Day 6
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.
Time frame: Day 1 to Day 6
Oral care frequency and oral health status will be assessed using the Oral Care Assessment Scale for Intensive Care Patients (OCAS-ICP). The scale consists of 10 assessment parameters and 17 factors corresponding to these parameters. Each category is scored from 0 to 4 depending on the presence of relevant factors. The total score obtained from the scale ranges from 0 to 26, with higher scores indicating poorer oral health status and a greater presence of risk factors, and lower scores indicating better oral health status. Patients will be evaluated daily during their intensive care unit stay. Based on the total OCAS-ICP score, oral care will be planned and implemented as follows: patients with a total score of 0-8 points will receive oral care twice daily (2×1), those with 9-17 points will receive oral care four times daily (4×1), and those with 18-26 points will receive oral care six times daily (6×1).Patients will be evaluated daily from Day 1 to Day 6.
Marmara University
Other
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
Acronym: ORAVAP-RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07551258
Cross Infection, Disease Attributes
L'Hospitalet de Llobregat, Barcelona, Spain
View Trial DetailsNCT07423208
Cross Infection, Disease Attributes
Ljubljana, Slovenia
View Trial DetailsNCT07403474
Cross Infection, Disease Attributes
Nîmes, France
View Trial DetailsNCT07369336
Cross Infection, Disease Attributes
Lahore, Punjab Province, Pakistan
View Trial Details