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Completed

NCT Number: NCT07287566

Impact of Oral Care on Ventilator Associated Pneumonia

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

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Key information

Conditions

Ventilator Associated Pneumonia ( VAP) Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Intensive Care Units, Children Hospital, Ain shams university

Cairo, 00002, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

dentate mechanically ventilated

-

Exclusion criteria

  • primary immune deficiency coagulation disorders jaw fractures

Treatment and study plan

Toothbrushing + Chlorhexidine

Procedure

three times daily for 5 minutes

Routine oral care + Chlorohexidine

Procedure

three times daily for 5 minutes

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Impact of Different Methods of Oral Hygiene on Incidence of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit

Acronym: OH-VAP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

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.

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