Impact of Toothbrushing Without Chlorhexidine on Oral Hygiene in Intubated Patients
Effect of Toothbrushing Without Chlorhexidine on Oral Hygiene Indices and Risks of Systemic Complications in Patients With Orotracheal Intubation: Randomized Pilot Clinical Study and Cost-effectiveness Analysis.
This study tests if brushing teeth without chlorhexidine helps keep the mouths of intubated patients cleaner and reduces the risk of infections like pneumonia and sepsis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Locations | 1 site (Sao Paulo) |
| Trial ID | NCT06453122 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of oral hygiene practices in critically ill patients who are orotracheally intubated, specifically comparing toothbrushing with and without the use of chlorhexidine. The research aims to determine if omitting chlorhexidine affects the accumulation of dental plaque and the risk of systemic complications such as pneumonia and sepsis. The study will involve regular oral hygiene procedures performed every eight hours, assessing the cost-effectiveness and safety of the new protocol. The findings could inform best practices for oral care in intensive care settings.
Who should consider this trial
Good fit: Ideal candidates include adult ICU patients over 18 years old who are orotracheally intubated and have no oral infections.
Not a fit: Patients who are unable to undergo oral hygiene procedures or have existing oral infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer oral hygiene practices for intubated patients, potentially reducing the risk of serious complications.
How similar studies have performed: While there is limited literature on this specific approach, recent recommendations suggest a shift away from chlorhexidine, indicating a need for further investigation into alternative oral hygiene methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients admitted to the adult ICU; * age over 18; * both sexes; * orotracheal intubation monitored from the first day; * absence of foci of infection in the oral cavity (periapical lesions, * periodontal abscesses, extensive cavities, opportunistic infections); * presence of at least five teeth per dental arch Exclusion Criteria: * patients in whom oral hygiene is not possible; * patients extubated before 24 hours from baseline; * patients with foci of infection in the oral cavity present in the baseline moment; * patients who died before 24 hours from baseline; * patients whose guardians do not authorize the research to be carried out; * patients whose information about oral and general health and other study variables are not available in the medical record, are doubtful or not capable of collection. * patients after heart surgery * patients with reintubation
Where this trial is running
Sao Paulo
- Hospital israelita Albert Einstein — Sao Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Fernanda de P Eduardo — Hospital Israelita Albert Einstein
- Study coordinator: Fernanda P Eduardo, PhD
- Email: fpeduard@einstein.br
- Phone: 5511999037553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.