Ventilator-associated Pneumonia and Oral HealthNCT06966817
The Effect of Two Different Oral Care Solutions on Ventilator-Associated Pneumonia and Oral Health of Mechanically Ventilated Patients in the Intensive Care Unit
A study testing Experimental Group(cetylpyridinium chloride) in people with Ventilator-associated Pneumonia and Oral Health, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to evaluate the effects of two different oral care solutions on ventilator-associated pneumonia and oral health in mechanically ventilated participants in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventilator-associated Pneumonia and Oral Health
- What is being tested?
- Experimental Group(cetylpyridinium chloride)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 Aug 2025
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requiring mechanical ventilation for at least 48 hours
- Not having a diagnosis of aspiration pneumonia
- Having a Clinical Lung Infection Score (CPIS) <6 on the first day
- Not having a diagnosis of pneumonia or COVID
- Not having facial or oral trauma
- Being within the first 24 hours of the intubation process
- Not having a medical impediment to elevating the head of the bed 30o
Who cannot join
- Not accepting to participate in the study
- Termination of MV support for less than 48 hours
- Being allergic to any of the solutions to be used in oral care
- Being diagnosed with immunodeficiency
- Having thrombocytopenia, leukopenia and oral aphthae, stomatitis, candidiasis, gingivitis
- Using immunosuppressive drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, 06010
About this study
The aim of this observational study is to evaluate the effects of two different oral care solutions on ventilator-associated pneumonia and oral health in mechanically ventilated participants in the intensive care unit.
Did oral health improve in participants who used cetylpyridinium chloride? Did pneumonia develop? Did oral health improve in participants who used chlorhexidine chloride? Did pneumonia develop? The results will be evaluated by giving oral care to the participants with these solutions for 5 days with the same protocol.
Read the detailed description
Ventilator-associated pneumonia (VAP) is defined as pulmonary parenchymal infection in patients exposed to invasive mechanical ventilation for at least 48 hours and is a part of intensive care unit (ICU)-acquired pneumonia. Ventilator-associated pneumonia is the most common intensive care unit (ICU)-acquired infection among patients receiving invasive mechanical ventilation. When the VAP data of surgical and medical ICUs of thirty-six developing countries, including our country, for the years 2013-2018 were evaluated; the average VAP rate was determined as 11.47 per 1000 ventilator days. It contributes to the increase in hospital mortality, MV and ICU hospital stay. Therefore, it worsens the condition of the critically ill patient and increases the total hospitalization cost. It has become mandatory to take preventive measures to ensure control and reduce the incidence of VAP. Preventive strategies to prevent the development of pneumonia in ventilated patients are based on the implementation of infection control, i.e., avoiding prolonged ventilation with adequate sedation and weaning protocols, avoiding biofilm formation on the endotracheal tube and microaspiration of subglottic secretions, avoiding bacterial translocation from the stomach to the upper airway, and avoiding oropharyngeal colonization. Lack of effective oral hygiene results in the development of dental plaque deposits on the teeth within 72 hours, which can be reservoirs for potential respiratory pathogens. Bacteria present in plaque serve as a reservoir for potential pathogens that can enter the respiratory tract. Because of this potential for infection, oral hygiene is important in patients receiving mechanical ventilation. Keeping a patient's mouth clean and disease-free (oral hygiene) can help prevent VAP. Mouthwashes have been recommended as a regular oral care because they can reduce costs and reduce plaque formation. The type, concentration, dose, and frequency of use of the rinse may also affect antibacterial efficacy. There remains uncertainty regarding the most effective protocols, including the types of personnel involved, frequency of oral care, whether antiseptics should be used, and if so, what type of antiseptic to use (e.g., chlorhexidine gluconate, sodium bicarbonate, hydrogen peroxide, cetylpyridinium chloride, povidone-iodine). Currently, the Centers for Disease Control and Prevention (CDC) recommends oral hygiene with 0.12% chlorhexidine (CHX) during the perioperative period of cardiac surgery, but there are no recommendations for its routine use in the prevention of nosocomial pneumonia in critically ill patients. Cetylpyridinium chloride (CPC) is a broad-spectrum antimicrobial agent that has been shown to be effective in reducing dental plaque and preventing gingivitis. Cetylpyridinium chloride 0.05% has been used as an alternative to reduce dental plaque and gingivitis in patients who develop mucosal irritation and stains due to CHX.
In light of all this information, oral care is one of the most important treatments for mechanically ventilated patients in the intensive care unit. It supports the treatment of intensive care patients and can prevent respiratory tract infections. For this reason, it is important to determine the effectiveness of oral care solutions used in patients and their effects on ventilator-associated pneumonia.
The aim of this study is to evaluate the effects of two different oral care solutions on ventilator-associated pneumonia and oral health of patients on mechanical ventilation in the intensive care unit.
H0: There is no difference between the development of VAP and oral health of patients on mechanical ventilation in the intensive care unit where 0.25% chlorhexidine gluconate is used in oral care and the development of VAP and oral health of patients on mechanical ventilation in the intensive care unit where 0.05% cetylpyridinium chloride is used in oral care.
H1: There is a difference between the development of VAP and oral health of patients on mechanical ventilation in the intensive care unit where 0.25% chlorhexidine gluconate is used in oral care and the development of VAP and oral health of patients on VAP and oral health of patients on oral care who 0.05% cetylpyridinium chloride is used in oral care.
- Being tested
- control group(chlorhexidine), Experimental Group(cetylpyridinium chloride)
- Keywords
- ventilator-associated pneumonia , oral health, ventilator-associated pneumonia ,oral health
- 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.
control group(chlorhexidine)Drug
The sponge swab is dipped in 0.25% chlorhexidine solution and used once for each part of the mouth, 4 times a day to provide oral care.
Experimental Group(cetylpyridinium chloride)Drug
The mouth is cleaned by dipping a sponge swab into 0.05% cetylpyridinium chloride solution and using it once for each part of the mouth, 4 times a day.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Oral care for control group-1: First, the patient's teeth are brushed twice a day (06:00-18:00) with a small-headed, soft-bristled toothbrush, fluoride/non-foaming toothpaste and sterile water. Then, the mouth is aspirated to remove secretions and residues. After brushing, the sponge stick is dipped in 0.25% chlorhexidine solution and the mouth is cleaned in a way that it is used only once for each section of the mouth. In addition, between 12:00-24:00, the sponge stick is dipped in 0.25% chlorhexidine solution and the mouth is cleaned in a way that it is used only once for each section of the mouth. Receives: Drug: control group(chlorhexidine) |
| experimental group | Active comparator | Oral care for experimental group-2: First, the patient's teeth are brushed twice a day (06:00-18:00) with a small-headed, soft-bristled toothbrush, fluoride/non-foaming toothpaste and sterile water. After brushing, the sponge swab is dipped into 0.05% cetylpyridinium chloride solution and the mouth is cared for in a way that it can be used only once for each part of the mouth. In addition, between 12:00 and 24:00, the sponge swab is dipped into 0.05% cetylpyridinium chloride solution and the mouth is cared for in a way that it can be used only once for each part of the mouth. Receives: Drug: Experimental Group(cetylpyridinium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFECTS OF TWO DIFFERENT ORAL CARE SOLUTIONS ON VENTILATOR-ASSOCIATED PNEUMONIA AND ORAL HEALTH OF PATIENTS CONNECTED TO MECHANICAL VENTILATORS IN THE INTENSIVE CARE UNIT
The same person evaluates the patients' mouths every day at 07:00 with the oral hygiene oral assessment scale.
On the 1st, 3rd and 5th days, patients are evaluated with the clinical pulmonary infection score. After all these evaluations, the patient is diagnosed with pneumonia or not by the intensive care specialist.
Measured: from registration until the end of the 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 May 2024
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated Pneumonia and Oral HealthStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Before starting the study, the purpose of this study was explained to all nurses working in the intensive care unit and a 1-hour training was given about the study. The content of this training included theoretical information for nurses and guidance on the correct application of the oral care protocol. After the oral care application protocol in the intensive care unit was effectively implemented by the nurses, the data collection phase of the study was started. After the compliance of the patients admitted to the intensive care unit with the study inclusion criteria was evaluated, the oral care protocol to be applied to the patients was explained to the relatives of the patients included in the study and written and verbal consents were obtained.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- bediye öztaş, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966817
- Sponsor's protocol ID
- AEŞH-EK1-2024-0034
- Status last verified
- Jun 2025
- First submitted
- 4 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Oral Care Solutions on Ventilator-Associated Pneumonia and Oral Health of Mechanically Ventilated Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06966817
- Acronym / sponsor ID
- AEŞH-EK1-2024-0034
- Keywords
- ventilator-associated pneumonia , oral health, ventilator-associated pneumonia ,oral health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 13 May 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.
The aim of this observational study is to evaluate the effects of two different oral care solutions on ventilator-associated pneumonia and oral health in mechanically ventilated participants in the intensive care unit.
Did oral health improve in participants who used cetylpyridinium chloride? Did pneumonia develop? Did oral health improve in participants who used chlorhexidine chloride? Did pneumonia develop? The results will be evaluated by giving oral care to the participants with these solutions for 5 days with the same protocol.
Detailed description
Ventilator-associated pneumonia (VAP) is defined as pulmonary parenchymal infection in patients exposed to invasive mechanical ventilation for at least 48 hours and is a part of intensive care unit (ICU)-acquired pneumonia. Ventilator-associated pneumonia is the most common intensive care unit (ICU)-acquired infection among patients receiving invasive mechanical ventilation. When the VAP data of surgical and medical ICUs of thirty-six developing countries, including our country, for the years 2013-2018 were evaluated; the average VAP rate was determined as 11.47 per 1000 ventilator days. It contributes to the increase in hospital mortality, MV and ICU hospital stay. Therefore, it worsens the condition of the critically ill patient and increases the total hospitalization cost. It has become mandatory to take preventive measures to ensure control and reduce the incidence of VAP. Preventive strategies to prevent the development of pneumonia in ventilated patients are based on the implementation of infection control, i.e., avoiding prolonged ventilation with adequate sedation and weaning protocols, avoiding biofilm formation on the endotracheal tube and microaspiration of subglottic secretions, avoiding bacterial translocation from the stomach to the upper airway, and avoiding oropharyngeal colonization. Lack of effective oral hygiene results in the development of dental plaque deposits on the teeth within 72 hours, which can be reservoirs for potential respiratory pathogens. Bacteria present in plaque serve as a reservoir for potential pathogens that can enter the respiratory tract. Because of this potential for infection, oral hygiene is important in patients receiving mechanical ventilation. Keeping a patient's mouth clean and disease-free (oral hygiene) can help prevent VAP. Mouthwashes have been recommended as a regular oral care because they can reduce costs and reduce plaque formation. The type, concentration, dose, and frequency of use of the rinse may also affect antibacterial efficacy. There remains uncertainty regarding the most effective protocols, including the types of personnel involved, frequency of oral care, whether antiseptics should be used, and if so, what type of antiseptic to use (e.g., chlorhexidine gluconate, sodium bicarbonate, hydrogen peroxide, cetylpyridinium chloride, povidone-iodine). Currently, the Centers for Disease Control and Prevention (CDC) recommends oral hygiene with 0.12% chlorhexidine (CHX) during the perioperative period of cardiac surgery, but there are no recommendations for its routine use in the prevention of nosocomial pneumonia in critically ill patients. Cetylpyridinium chloride (CPC) is a broad-spectrum antimicrobial agent that has been shown to be effective in reducing dental plaque and preventing gingivitis. Cetylpyridinium chloride 0.05% has been used as an alternative to reduce dental plaque and gingivitis in patients who develop mucosal irritation and stains due to CHX.
In light of all this information, oral care is one of the most important treatments for mechanically ventilated patients in the intensive care unit. It supports the treatment of intensive care patients and can prevent respiratory tract infections. For this reason, it is important to determine the effectiveness of oral care solutions used in patients and their effects on ventilator-associated pneumonia.
The aim of this study is to evaluate the effects of two different oral care solutions on ventilator-associated pneumonia and oral health of patients on mechanical ventilation in the intensive care unit.
H0: There is no difference between the development of VAP and oral health of patients on mechanical ventilation in the intensive care unit where 0.25% chlorhexidine gluconate is used in oral care and the development of VAP and oral health of patients on mechanical ventilation in the intensive care unit where 0.05% cetylpyridinium chloride is used in oral care.
H1: There is a difference between the development of VAP and oral health of patients on mechanical ventilation in the intensive care unit where 0.25% chlorhexidine gluconate is used in oral care and the development of VAP and oral health of patients on VAP and oral health of patients on oral care who 0.05% cetylpyridinium chloride is used in oral care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Before starting the study, the purpose of this study was explained to all nurses working in the intensive care unit and a 1-hour training was given about the study. The content of this training included theoretical information for nurses and guidance on the correct application of the oral care protocol. After the oral care application protocol in the intensive care unit was effectively implemented by the nurses, the data collection phase of the study was started. After the compliance of the patients admitted to the intensive care unit with the study inclusion criteria was evaluated, the oral care protocol to be applied to the patients was explained to the relatives of the patients included in the study and written and verbal consents were obtained.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: control group(chlorhexidine)Oral care for control group-1: First, the patient's teeth are brushed twice a day (06:00-18:00) with a small-headed, soft-bristled toothbrush, fluoride/non-foaming toothpaste and sterile water. Then, the mouth is aspirated to remove secretions and residues. After brushing, the sponge stick is dipped in 0.25% chlorhexidine solution and the mouth is cleaned in a way that it is used only once for each section of the mouth. In addition, between 12:00-24:00, the sponge stick is dipped in 0.25% chlorhexidine solution and the mouth is cleaned in a way that it is used only once for each section of the mouth. |
| experimental group | Active comparator | Drug: Experimental Group(cetylpyridinium chloride)Oral care for experimental group-2: First, the patient's teeth are brushed twice a day (06:00-18:00) with a small-headed, soft-bristled toothbrush, fluoride/non-foaming toothpaste and sterile water. After brushing, the sponge swab is dipped into 0.05% cetylpyridinium chloride solution and the mouth is cared for in a way that it can be used only once for each part of the mouth. In addition, between 12:00 and 24:00, the sponge swab is dipped into 0.05% cetylpyridinium chloride solution and the mouth is cared for in a way that it can be used only once for each part of the mouth. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Requiring mechanical ventilation for at least 48 hours
- Not having a diagnosis of aspiration pneumonia
- Having a Clinical Lung Infection Score (CPIS) <6 on the first day
- Not having a diagnosis of pneumonia or COVID
- Not having facial or oral trauma
Key exclusion criteria (6 listed)
- Not accepting to participate in the study
- Termination of MV support for less than 48 hours
- Being allergic to any of the solutions to be used in oral care
- Being diagnosed with immunodeficiency
- Having thrombocytopenia, leukopenia and oral aphthae, stomatitis, candidiasis, gingivitis
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 |
|---|---|---|
| control group(chlorhexidine)The sponge swab is dipped in 0.25% chlorhexidine solution and used once for each part of the mouth, 4 times a day to provide oral care. | Drug | control group |
| Experimental Group(cetylpyridinium chloride)The mouth is cleaned by dipping a sponge swab into 0.05% cetylpyridinium chloride solution and using it once for each part of the mouth, 4 times a day. | Drug | experimental group |
Primary outcome
EFFECTS OF TWO DIFFERENT ORAL CARE SOLUTIONS ON VENTILATOR-ASSOCIATED PNEUMONIA AND ORAL HEALTH OF PATIENTS CONNECTED TO MECHANICAL VENTILATORS IN THE INTENSIVE CARE UNIT
Time frame: from registration until the end of the 5th day
The same person evaluates the patients' mouths every day at 07:00 with the oral hygiene oral assessment scale. On the 1st, 3rd and 5th days, patients are evaluated with the clinical pulmonary infection score. After all these evaluations, the patient is diagnosed with pneumonia or not by the intensive care specialist.
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 12 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Ventilator-associated Pneumonia and Oral Health
Recruiting
Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
Ventilator Associated Pneumonia, Bronchopulmonary Dysplasia
Active, not recruiting
Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit
Microbial Colonization, Ventilator Associated Pneumonia
Not yet recruiting
Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units
Mechanical Ventilation, Infection Prevention
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.
bediye öztaş principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group(cetylpyridinium chloride) in people with Ventilator-associated Pneumonia and Oral Health, run by Saglik Bilimleri Universitesi at 1 site 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 7 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
EFFECTS OF TWO DIFFERENT ORAL CARE SOLUTIONS ON VENTILATOR-ASSOCIATED PNEUMONIA AND ORAL HEALTH OF PATIENTS CONNECTED TO MECHANICAL VENTILATORS IN THE INTENSIVE CARE UNIT (time frame: from registration until the end of the 5th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2025.