Ventilator Associated Pneumonia ( VAP)OH-VAPNCT07287566
Impact of Oral Care on Ventilator Associated Pneumonia
A study testing Toothbrushing + Chlorhexidine and Routine oral care + Chlorohexidine in people with Ventilator Associated Pneumonia ( VAP), run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial was to find out whether cleaning the mouths of children in the Pediatric Intensive Care Unit (PICU) with toothbrushing and chlorhexidine lowers the chance of getting lung infections in patients on breathing machines compared to routine mouth care. Read more about this study
- Who is it for?
- Ages 18 months to 16 years
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP)
- What is being tested?
- Toothbrushing + Chlorhexidine and Routine oral care + Chlorohexidine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2024to 15 Jul 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 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -
Who cannot join
- primary immune deficiency coagulation disorders jaw fractures
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Intensive Care Units, Children Hospital, Ain shams university
Cairo, 00002
About this study
Official title: The Impact of Different Methods of Oral Hygiene on Incidence of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit
The goal of this clinical trial was to find out whether cleaning the mouths of children in the Pediatric Intensive Care Unit (PICU) with toothbrushing and chlorhexidine lowers the chance of getting lung infections in patients on breathing machines compared to routine mouth care. The study determined whether this approach changed how long children need a breathing machine, how many days they stayed in the PICU, and whether it affects survival. The main questions it aimed to answer were:
- Did toothbrushing with chlorhexidine, compared to routine mouth care, lowered the risk of lung infections in patients on breathing machines in the PICU?
- Did this approach also affect recovery outcomes, including duration of needing a breathing machine, length of PICU stay, and survival rates?
Read more
Researchers compared toothbrushing and chlorhexidine to routine mouth care to see if toothbrushing and chlorhexidine lowered the risk of lung infections in patients on breathing machines.
Participants:
Had safety practices to prevent lung infections in patients on breathing machines Had toothbrushing and chlorhexidine or routine mouth care three times daily 5 minutes in each Had physical check-up and any tests needed as part of their care
Read the detailed description
Pediatric dentist trained the nurses to follow the proper oral care protocol. Safe practices as keeping the patient's head slightly raised while lying in bed and clean the patients mouth regularly to remove germs. Participants and researcher didn't know which oral care method was being administered making this double blinded study. The participants were divided into two groups 59 patients in each group. In Tooth brushing group, tooth paste and soft tooth brush was positioned at 45 degree angle with a firm gentle pressure, brushing back and forth or using a circular motion 15 to 20 times before moving to the next area for one minute plus application of chlorhexidine mouthwash to a swab on the oral mucosa, teeth, gums, hard palate, and tongue, followed by 20 milliliter (mL) of normal saline, the procedure was finished with hypo pharyngeal suctioning. In routine oral care group only a swab with chlorhexidine and rubbing it on the surface of the tongue, gum and mucosa followed by 20 mL of normal saline, the procedure was finished with hypo pharyngeal suctioning.
investigations include laboratory (Complete blood picture, C-reactive protein and Venous blood gases (VBG) were done. Radiological and microbiological included sputum culture collected on fifth day were also done.
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Being tested
- Toothbrushing + Chlorhexidine, Routine oral care + Chlorohexidine
- Keywords
- oral hygiene, ventilator associated pneumonia, chlorohexidine, mechanical ventilation, pediatric intensive care unit
- 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.
Toothbrushing + ChlorhexidineProcedure or surgery
three times daily for 5 minutes
Routine oral care + ChlorohexidineProcedure or surgery
three times daily for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Toothbrushing + Chlorohexidine Receives: Procedure: Toothbrushing + Chlorhexidine |
| control group | Active comparator | Routine oral care + Chlorohexidine Receives: Procedure: Routine oral care + Chlorohexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of VAP in pediatric patients in PICU receiving toothbrushing and chlorohexidine in comparison to routine oral hygiene
number of patients who develop VAP
Measured: Baseline, Day 2, Day3, Day 4 and Day 5 of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Jun 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Ain Shams 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed R. Ahmed, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287566
- Sponsor's protocol ID
- FMASU MS407 /2024
- Other IDs
- FMA MS407 /2024
- Acronym
- OH-VAP
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share
Publications
de Lacerda Vidal CF, Vidal AK, Monteiro JG Jr, Cavalcanti A, Henriques APC, Oliveira M, Godoy M, Coutinho M, Sobral PD, Vilela CA, Gomes B, Leandro MA, Montarroyos U, Ximenes RA, Lacerda HR. Impact of oral hygiene involving toothbrushing versus chlorhexidine in the prevention of ventilator-associated pneumonia: a randomized study. BMC Infect Dis. 2017 Jan 31;17(1):112. doi: 10.1186/s12879-017-2188-0.
PubMed 28143414Rezk AR, Hassan SA, Abd Elhakam RM, Kamel AM, Bakry NA. Tooth brushing versus routine oral care impact on ventilator-associated pneumonia in PICU: a clinical trial. BMC Pediatr. 2026 Jul 24;26(1):683. doi: 10.1186/s12887-026-07239-x.
PubMed 42502162
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Methods of Oral Hygiene on Incidence of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07287566
- Acronym / sponsor ID
- OH-VAP / FMASU MS407 /2024
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Keywords
- oral hygiene, ventilator associated pneumonia, chlorohexidine, mechanical ventilation, pediatric intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 17 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.
The goal of this clinical trial was to find out whether cleaning the mouths of children in the Pediatric Intensive Care Unit (PICU) with toothbrushing and chlorhexidine lowers the chance of getting lung infections in patients on breathing machines compared to routine mouth care. The study determined whether this approach changed how long children need a breathing machine, how many days they stayed in the PICU, and whether it affects survival. The main questions it aimed to answer were:
- Did toothbrushing with chlorhexidine, compared to routine mouth care, lowered the risk of lung infections in patients on breathing machines in the PICU?
- Did this approach also affect recovery outcomes, including duration of needing a breathing machine, length of PICU stay, and survival rates?
Researchers compared toothbrushing and chlorhexidine to routine mouth care to see if toothbrushing and chlorhexidine lowered the risk of lung infections in patients on breathing machines.
Participants:
Had safety practices to prevent lung infections in patients on breathing machines Had toothbrushing and chlorhexidine or routine mouth care three times daily 5 minutes in each Had physical check-up and any tests needed as part of their care
Detailed description
Pediatric dentist trained the nurses to follow the proper oral care protocol. Safe practices as keeping the patient's head slightly raised while lying in bed and clean the patients mouth regularly to remove germs. Participants and researcher didn't know which oral care method was being administered making this double blinded study. The participants were divided into two groups 59 patients in each group. In Tooth brushing group, tooth paste and soft tooth brush was positioned at 45 degree angle with a firm gentle pressure, brushing back and forth or using a circular motion 15 to 20 times before moving to the next area for one minute plus application of chlorhexidine mouthwash to a swab on the oral mucosa, teeth, gums, hard palate, and tongue, followed by 20 milliliter (mL) of normal saline, the procedure was finished with hypo pharyngeal suctioning. In routine oral care group only a swab with chlorhexidine and rubbing it on the surface of the tongue, gum and mucosa followed by 20 mL of normal saline, the procedure was finished with hypo pharyngeal suctioning.
investigations include laboratory (Complete blood picture, C-reactive protein and Venous blood gases (VBG) were done. Radiological and microbiological included sputum culture collected on fifth day were also done.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: Toothbrushing + ChlorhexidineToothbrushing + Chlorohexidine |
| control group | Active comparator | Procedure: Routine oral care + ChlorohexidineRoutine oral care + Chlorohexidine |
Who may qualify
- Ages
- 18 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- primary immune deficiency coagulation disorders jaw fractures
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 |
|---|---|---|
| Toothbrushing + Chlorhexidinethree times daily for 5 minutes | Procedure or surgery | intervention group |
| Routine oral care + Chlorohexidinethree times daily for 5 minutes | Procedure or surgery | control group |
Primary outcome
incidence of VAP in pediatric patients in PICU receiving toothbrushing and chlorohexidine in comparison to routine oral hygiene
Time frame: Baseline, Day 2, Day3, Day 4 and Day 5 of enrollment
number of patients who develop 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 17 Dec 2025.
- Results publication: PubMed 28143414de Lacerda Vidal CF, Vidal AK, Monteiro JG Jr, Cavalcanti A, Henriques APC, Oliveira M, Godoy M, Coutinho M, Sobral PD, Vilela CA, Gomes B, Leandro MA, Montarroyos U, Ximenes RA, Lacerda HR. Impact of oral hygiene involving toothbrushing versus chlorhexidine in the prevention of ventilator-associated pneumonia: a randomized study. BMC Infect Dis. 2017 Jan 31;17(1):112. doi: 10.1186/s12879-017-2188-0.
- Derived from this study: PubMed 42502162Rezk AR, Hassan SA, Abd Elhakam RM, Kamel AM, Bakry NA. Tooth brushing versus routine oral care impact on ventilator-associated pneumonia in PICU: a clinical trial. BMC Pediatr. 2026 Jul 24;26(1):683. doi: 10.1186/s12887-026-07239-x.
- The Egyptian Journal of Critical Care Medicine. 5(3):87-91.Link provided by the sponsor.
- Prevention of VAP: Endless evolving evidences-systematic literature review.Link provided by the sponsor.
- Individual participant dataSharing planned: No. no plan to share
Related trials for Ventilator Associated Pneumonia ( VAP)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
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.
Ahmed R. Ahmed, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothbrushing + Chlorhexidine and Routine oral care + Chlorohexidine in people with Ventilator Associated Pneumonia ( VAP), run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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 17 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 1 site in Egypt. 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?
incidence of VAP in pediatric patients in PICU receiving toothbrushing and chlorohexidine in comparison to routine oral hygiene (time frame: Baseline, Day 2, Day3, Day 4 and Day 5 of enrollment). 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 NCT07287566, which also lists 2 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 17 Dec 2025.