Impact of Oral Care on Ventilator Associated Pneumonia

NCT07287566 | Completed

• 2 other identifiers: FMASU MS407 /2024FMA MS407 /2024
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Ventilator Associated Pneumonia ( VAP)

Keywords

oral hygiene; ventilator associated pneumonia; chlorohexidine; mechanical ventilation; pediatric intensive care unit

Outcome Measures

Primary Outcomes (1)

• incidence of VAP in pediatric patients in PICU receiving toothbrushing and chlorohexidine in comparison to routine oral hygiene

  number of patients who develop VAP

  Baseline, Day 2, Day3, Day 4 and Day 5 of enrollment

Study Arms (2)

intervention group

EXPERIMENTAL

Toothbrushing + Chlorohexidine

Procedure: Toothbrushing + Chlorhexidine

control group

ACTIVE COMPARATOR

Routine oral care + Chlorohexidine

Procedure: Routine oral care + Chlorohexidine

Interventions

Toothbrushing + Chlorhexidine PROCEDURE

three times daily for 5 minutes

intervention group

Routine oral care + Chlorohexidine PROCEDURE

three times daily for 5 minutes

control group

Eligibility Criteria

• Age: 18 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• primary immune deficiency coagulation disorders jaw fractures

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Pediatric Intensive Care Units, Children Hospital, Ain shams university

Cairo, 00002, Egypt

Location

Related Publications (1)

• 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.

  PMID: 28143414 RESULT

Related Links

• The Egyptian Journal of Critical Care Medicine. 5(3):87-91.
• Prevention of VAP: Endless evolving evidences-systematic literature review.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Toothbrushing; Chlorhexidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Ahmed R. Ahmed, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 17, 2025
• Study Start: June 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)