Pediatrics · Medical Literature
Tooth brushing versus routine oral care impact on ventilator-associated pneumonia in PICU: a clinical trial.
Abstract
Ventilator-associated pneumonia (VAP) is a frequent and serious infection among mechanically ventilated children in pediatric intensive care units (PICUs), with oral colonization playing a key role in its pathogenesis. Effective oral hygiene measures are therefore crucial to reduce VAP incidence and improve clinical outcomes. This study aimed to compare the incidence of VAP in PICU patients receiving routine oral care versus toothbrushing with chlorhexidine, and to evaluate the impact on mechanical ventilation duration, PICU stay, and mortality with secondary outcomes including microbiological colonization, inflammatory markers, and inotropic support requirements. A parallel-group superiority randomized controlled trial. A randomized controlled trial was conducted on 118 children aged 18 months to 16 years, including PICU patients requiring invasive mechanical ventilation for ≥ 48 h. On admission, patients were randomly allocated into two groups: the intervention group received oral care with toothbrushing plus 0.12% chlorhexidine mouth rinse, while the control group received routine care with 0.12% chlorhexidine rinse only. Both procedures were performed three times daily. VAP was diagnosed according to CDC criteria. Quantitative and qualitative analyses assessed variables distinguishing VAP cases from controls, and multivariate logistic regression identified independent predictors of disease severity. The results of our study revealed that VAP occurred in 31 patients (52.5%) in the control group and 25 patients (42.3%) in the intervention group, indicating a lower incidence with toothbrushing plus chlorhexidine, although this difference was not statistically significant (p = 0.36). Among all participants, 45.8% died and 54.2% were discharged. Mortality was higher in the control group (53.7%) compared with the intervention group (46.3%), while discharge rates favored the intervention group (53.1% vs. 46.9%); however, these differences did not reach statistical significance (p = 0.46). Positive sputum cultures were more frequent in the control group (55.6%) than in the intervention group (44.4%), whereas negative cultures were more common among intervention patients (54.7% vs. 45.3%), with no significant difference between groups (p = 0.268). Although adding toothbrushing to routine chlorhexidine oral care did not produce a statistically significant reduction in VAP incidence or mortality, a consistent trend toward clinical benefit was observed across multiple outcome measures, including lower rates of positive sputum cultures, reduced inotropic support requirements, and fewer new pulmonary infiltrates. These findings highlight the potential value of enhanced oral hygiene in the PICU and support the need for larger multicenter studies to confirm its effect. ClinicalTrials.gov, NCT07287566. Registered on November 20, 2025. Retrospectively registered at https://clinicaltrials.gov/ct2/show/NCT07287566 . The full study protocol and the statistical analysis plan are included in this document and are available from the corresponding author upon reasonable request.
Clinical relevance
VAP remains one of the most frequent and serious nosocomial infections in mechanically ventilated pediatric patients, with oral colonization serving as a key pathogenic driver. This RCT addresses an evidence gap in PICU-specific oral hygiene protocols by directly comparing toothbrushing plus chlorhexidine against chlorhexidine rinse alone in children requiring invasive mechanical ventilation for ≥48 hours. Given the high VAP-attributable morbidity and mortality in PICUs, optimizing oral care bundles has immediate clinical and resource utilization relevance for pediatric intensivists.
Key findings
1. VAP incidence was 52.5% in the control group (chlorhexidine rinse alone) versus 42.3% in the intervention group (toothbrushing plus chlorhexidine), representing a 10.2 percentage-point absolute reduction that did not reach statistical significance (p = 0.36). 2. All-cause PICU mortality was 45.8% across the cohort; mortality was numerically higher in the control group (53.7%) versus the intervention group (46.3%), though this difference was not statistically significant (p = 0.46). 3. Discharge rates favored the intervention group (53.1% vs. 46.9%), consistent with the mortality trend, but again without statistical significance (p = 0.46). 4. Positive sputum culture rates were higher in the control group (55.6%) than in the intervention group (44.4%), while negative cultures were more prevalent in the intervention group (54.7% vs. 45.3%); this difference did not reach statistical significance (p = 0.268). 5. Consistent non-significant trends favoring toothbrushing were observed across multiple secondary outcomes, including reduced inotropic support requirements and fewer new pulmonary infiltrates, suggesting a potential composite clinical benefit. 6. The study was a single-center parallel-group superiority RCT enrolling 118 children aged 18 months to 16 years; the sample size was likely underpowered to detect the observed effect sizes, limiting definitive conclusions.
Practice implications
Pediatric intensivists should consider incorporating structured toothbrushing into existing chlorhexidine-based oral hygiene bundles for children on invasive mechanical ventilation for ≥48 hours, as the intervention demonstrated a consistent, clinically meaningful—though statistically non-significant—trend toward lower VAP rates, reduced microbiological colonization, and improved survival. Patient selection should prioritize those expected to require prolonged ventilation, where even modest absolute risk reductions in VAP incidence could translate into meaningful decreases in ventilator days and PICU length of stay. Given the trial's limited power and single-center design, current evidence supports this practice as a low-risk, low-cost adjunct while awaiting adequately powered multicenter RCTs to confirm efficacy before revising institutional VAP prevention guidelines.