InfectionToothbrushNCT07125495
The Effect of an Suction Toothbrush on the Development of Ventilator-Associated Pneumonia
A study testing Suction tootbrush and distiled water, suction tootbrush and .12% chlorhexidine gluconate and Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution in people with Infection and Intensive Care (ICU), run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
Literature suggests that suction toothbrushes may improve oral care in intubated patients by facilitating secretion removal and reducing microaspiration. This could decrease the need for endotracheal suctioning and lower the risk of ventilator-associated pneumonia (VAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Intensive Care (ICU), Intubation
- What is being tested?
- Suction tootbrush and distiled water, suction tootbrush and .12% chlorhexidine gluconate and Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 aged over 18 years
- who underwent orotracheal intubation after admission to the ICU,
- who had no known pneumonia or diagnosis of pneumonia at the time of intubation,
- who were intubated for more than 48 hours,
- who had no microorganisms detected in the tracheal aspirate within the first 48 hours,
- who had no lesions on the oral mucous membrane before intubation,
- who had no known allergy to chlorhexidine were included in the study.
Who cannot join
- Patients
- who under 18 years of age,
- those with a tracheostomy,
- those were intubated for less than 48 hours,
- those with microorganisms detected in their tracheal aspirate within the first 48 hours,
- those who underwent reintubation,
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- those were pregnant,
- those with lesions in the oral mucosa during intensive care admission,
- those with bleeding coagulation disorders or thrombocytopenia,
- those admitted to intensive care from an external institution while intubated, and those with a known chlorhexidine allergy were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koç University hospital Intensive care unit
Istanbul, 34010
About this study
Official title: The Effect of an Suction Toothbrush in Intubated Intensive Care Patients on the Development of Ventilator-Associated Pneumonia: A Randomized Controlled Trial
Literature suggests that suction toothbrushes may improve oral care in intubated patients by facilitating secretion removal and reducing microaspiration. This could decrease the need for endotracheal suctioning and lower the risk of ventilator-associated pneumonia (VAP). Therefore, this study aimed to examine the effect of a suction toothbrush on the development of VAP in intubated patients.
Read the detailed description
in the literature examining the superiority of a suction toothbrush over another regarding the frequency of oral care practices, appropriate solution and material use in intubated patients. It is believed that a suction toothbrush will both facilitate oral care and clear oral secretions. By minimizing secretion accumulation in the mouth, it will prevent microaspiration and reduce the need for endotracheal suctioning in patients. Determining the most effective oral care method is expected to reduce the incidence of ventilator-associated pneumonia and positively impact patient mortality. Considering all this information, the aim of this study was to examine the effect of a suction toothbrush on the development of ventilator-associated pneumonia in intubated patients.
- Conditions
- Infection, Intensive Care (ICU), Intubation, Intubation Complication
- Being tested
- Suction tootbrush and distiled water, suction tootbrush and .12% chlorhexidine gluconate, Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution
- Keywords
- oral care, tootbrush, intensive care, intubation, Ventilatory-associated pneumonia
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction tootbrush and distiled waterOther
All tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions.
suction tootbrush and .12% chlorhexidine gluconateOther
Every 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care.
Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solutionOther
All tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) and an oral care sponge used in oral care in the intensive care unit. After oral care, oropharyngeal secretions were aspirated.
| Study group | Role | What they receive |
|---|---|---|
| Suction tootbrush + distilled water | Experimental | All tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions. Receives: Other: Suction tootbrush and distiled water |
| Suction toothbrush + 0.12% chlorhexidine gluconate oral solution | Active comparator | Every 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care. Receives: Other: suction tootbrush and .12% chlorhexidine gluconate |
| oral care sponge + 0.12% chlorhexidine gluconate oral solution | Active comparator | All tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) with an oral care sponge used in oral care. Receives: Other: Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ventilatory associated pneumonia (VAP)
The development of ventilator-associated pneumonia (VAP) after entubation in the intensive care unit (Yes / no). If a patient presents signs and symptoms of VAP with both clinical Findings and laboratory findings, researchers will diagnose it as a VAP.
Measured: Patients were included 48 hours after admission to the intensive care unit and intubation. After 48 hours of intubation, the development of VAP will be considered as a positive.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Feb 2025
- Primary completion1 Jul 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Koc University Hospital
- Responsible party
- Principal investigator, Ayda Kebapci, Koç University
- Investigators
- Zeliha Genç, PhD, Principal investigator, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125495
- Sponsor's protocol ID
- ToothbrushICU
- Acronym
- Toothbrush
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Suction Toothbrush in Intubated Intensive Care Patients on the Development of Ventilator-Associated Pneumonia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07125495
- Acronym / sponsor ID
- Toothbrush / ToothbrushICU
- Conditions
- Infection, Intensive Care (ICU), Intubation, Intubation Complication
- Keywords
- oral care, tootbrush, intensive care, intubation, Ventilatory-associated pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Koc University Hospital
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 15 Aug 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.
Literature suggests that suction toothbrushes may improve oral care in intubated patients by facilitating secretion removal and reducing microaspiration. This could decrease the need for endotracheal suctioning and lower the risk of ventilator-associated pneumonia (VAP). Therefore, this study aimed to examine the effect of a suction toothbrush on the development of VAP in intubated patients.
Detailed description
in the literature examining the superiority of a suction toothbrush over another regarding the frequency of oral care practices, appropriate solution and material use in intubated patients. It is believed that a suction toothbrush will both facilitate oral care and clear oral secretions. By minimizing secretion accumulation in the mouth, it will prevent microaspiration and reduce the need for endotracheal suctioning in patients. Determining the most effective oral care method is expected to reduce the incidence of ventilator-associated pneumonia and positively impact patient mortality. Considering all this information, the aim of this study was to examine the effect of a suction toothbrush on the development of ventilator-associated pneumonia in intubated patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suction tootbrush + distilled water | Experimental | Other: Suction tootbrush and distiled waterAll tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions. |
| Suction toothbrush + 0.12% chlorhexidine gluconate oral solution | Active comparator | Other: suction tootbrush and .12% chlorhexidine gluconateEvery 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care. |
| oral care sponge + 0.12% chlorhexidine gluconate oral solution | Active comparator | Other: Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solutionAll tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) with an oral care sponge used in oral care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients
- who aged over 18 years
- who underwent orotracheal intubation after admission to the ICU,
- who had no known pneumonia or diagnosis of pneumonia at the time of intubation,
- who were intubated for more than 48 hours,
Key exclusion criteria (10 listed)
- Patients
- who under 18 years of age,
- those with a tracheostomy,
- those were intubated for less than 48 hours,
- those with microorganisms detected in their tracheal aspirate within the first 48 hours,
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 |
|---|---|---|
| Suction tootbrush and distiled waterAll tooth surfaces, oral mucosa, and the tongue and surrounding area were cleaned every 8 hours (3x1) with distilled water and a suction toothbrush. The aspiration feature of the suction toothbrush enabled oral care and simultaneous aspiration of oropharyngeal secretions. | Other | Suction tootbrush + distilled water |
| suction tootbrush and .12% chlorhexidine gluconateEvery 8 hours (3x1) 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) will be used with a suction toothbrush to clean all tooth surfaces, the oral mucosa, and the tongue. The aspiration feature of the suction toothbrush allows for the aspiration of oropharyngeal secretions during oral care. | Other | Suction toothbrush + 0.12% chlorhexidine gluconate oral solution |
| Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solutionAll tooth surfaces, oral mucosa, and the tongue and surrounding tongue were cleaned with 15 ml of 0.12% chlorhexidine gluconate oral solution (Adıgüzel, 2015) every 8 hours (3x1) and an oral care sponge used in oral care in the intensive care unit. After oral care, oropharyngeal secretions were aspirated. | Other | oral care sponge + 0.12% chlorhexidine gluconate oral solution |
Primary outcome
The ventilatory associated pneumonia (VAP)
Time frame: Patients were included 48 hours after admission to the intensive care unit and intubation. After 48 hours of intubation, the development of VAP will be considered as a positive.
The development of ventilator-associated pneumonia (VAP) after entubation in the intensive care unit (Yes / no). If a patient presents signs and symptoms of VAP with both clinical Findings and laboratory findings, researchers will diagnose it as a VAP.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Zeliha Genç, PhD principal investigator
Koc University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suction tootbrush and distiled water, suction tootbrush and .12% chlorhexidine gluconate and Oral care sponge and with 15 ml of 0.12% chlorhexidine gluconate oral solution in people with Infection and Intensive Care (ICU), run by Koç University 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 23 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The ventilatory associated pneumonia (VAP) (time frame: Patients were included 48 hours after admission to the intensive care unit and intubation. After 48 hours of intubation, the development of VAP will be considered as a positive.). 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 23 Apr 2026.