Ventilator Associated Pneumonia ( VAP)ORAVAP-RCTNCT07283380
Effect of Two Oral Care Methods on Oral Flora and VAP in Mechanically Ventilated Patients
A study testing Pediatric toothbrush and Sponge stick in people with Ventilator Associated Pneumonia ( VAP), run by Marmara University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP)
- What is being tested?
- Pediatric toothbrush and Sponge stick
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Zonguldak Ataturk State Hospital
Zonguldak, 67000
Zonguldak Atatürk State Hospital, Ministry of Health, Türkiye
Zonguldak, 67000
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Being tested
- Pediatric toothbrush, Sponge stick
- Keywords
- Oral Care, Oral Bacterial Colonization, Mechanically Ventilated Patients
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric toothbrushDevice
Oral care will be using a pediatric toothbrush for 5 days; oral swabs and CPIS scores will be monitored.
Sponge stickDevice
Oral care will be using a sponge stick for 5 days; oral swabs and CPIS scores will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric toothbrush group | Experimental | Patients will receive oral care with a pediatric toothbrush for 5 days. Oral swabs and CPIS scores will be monitored. Receives: 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. Receives: Device: Sponge stick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Day 1 and Day 6
Secondary outcomes (1)
Oral care frequency assessed by the Oral Care Assessment Scale for Intensive Care Patients (OCAS-ICP)
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.
Measured: Day 1 to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated Pneumonia ( VAP)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gulten OKUROĞLU, Assoc.Prof, Principal investigator, Marmara UniversityAyse AYDIN, PhDCand., Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283380
- Sponsor's protocol ID
- AYDIN-VAP-2025-001
- Acronym
- ORAVAP-RCT
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The decision regarding individual participant data (IPD) sharing has not yet been made. Due to ethical considerations and patient confidentiality concerns in critically ill populations, the research team remains undecided about whether de-identified data can be made available in the future.
Publications
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.
PubMed 30581995Miranda 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.
PubMed 27275074Terezakis 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.
PubMed 21470276
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07283380
- Acronym / sponsor ID
- ORAVAP-RCT / AYDIN-VAP-2025-001
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Keywords
- Oral Care, Oral Bacterial Colonization, Mechanically Ventilated Patients
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- "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).
| Arm | Type | Receives |
|---|---|---|
| Pediatric toothbrush group | Experimental | Device: Pediatric toothbrushPatients will receive oral care with a pediatric toothbrush for 5 days. Oral swabs and CPIS scores will be monitored. |
| Sponge stick group | Active comparator | Device: Sponge stickPatients will receive oral care with a sponge stick for 5 days. Oral swabs and CPIS scores will be monitored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric toothbrushOral care will be using a pediatric toothbrush for 5 days; oral swabs and CPIS scores will be monitored. | Device | Pediatric toothbrush group |
| Sponge stickOral care will be using a sponge stick for 5 days; oral swabs and CPIS scores will be monitored. | Device | Sponge stick group |
Primary outcome
Mean colony-forming unit (CFU) counts of oral bacterial colonization
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
Incidence of ventilator-associated pneumonia based on the Clinical Pulmonary Infection Score (CPIS)
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.
1 secondary outcome
Oral care frequency assessed by the Oral Care Assessment Scale for Intensive Care Patients (OCAS-ICP)
Time frame: Day 1 to Day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Results publication: PubMed 30581995Diaconu 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.
- Results publication: PubMed 27275074Miranda 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.
- Results publication: PubMed 21470276Terezakis 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.
- Endotracheal Tube Biofilm and its Impact on the Pathogenesis of Ventilator-Associated PneumoniaLink provided by the sponsor.
- Oral care practices for patients in Intensive Care Units: A pilot surveyLink provided by the sponsor.
- The impact of hospitalization on oral health: a systematic reviewLink provided by the sponsor.
- Individual participant dataSharing planned: No. The decision regarding individual participant data (IPD) sharing has not yet been made. Due to ethical considerations and patient confidentiality concerns in critically ill populations, the research team remains undecided about whether de-identified data can be made available in the future.
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Ventilator Associated Pneumonia ( VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulten OKUROĞLU, Assoc.Prof principal investigator
Marmara University
Ayse AYDIN, PhDCand. study director
Marmara University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric toothbrush and Sponge stick in people with Ventilator Associated Pneumonia ( VAP), run by Marmara University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean colony-forming unit (CFU) counts of oral bacterial colonization (time frame: Day 1 and Day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07283380, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.