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Effect of Toothbrushing Without Chlorhexidine on Oral Hygiene Indices in Patients With Orotracheal Intubation

NCT06453122 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-06-11

No results posted yet for this study

Summary

The oral hygiene method commonly used in intubated patients orotracheal is tooth brushing (mechanical removal) and washing the oral cavity and the orotracheal tube (TOT) with digluconate solution chlorhexidine (CLX). However, recent studies have demonstrated that the use of CLX in these conditions may expose the patient to a potential increased risk of mortality. Recent recommendations made by international bodies related to hospital biosafety no longer include the use of CLX in ICU oral hygiene routine. A question not yet answered in the literature is whether the absence of CLX in the critical patient's oral hygiene routine predisposes increased accumulation of dental plaque or microbial colonization related to the risk of systemic complications, such as pneumonia and sepsis. The cost-effectiveness of this protocol change also needs to be evaluated, as the withdrawal of CLX may result in changes in the risk profile morbidity and mortality during hospitalization. The present study aims to investigate whether brushing the oral cavity with mineral water changes the pattern of biofilm accumulation and clinical appearance of the oral mucosa in relation to brushing done with CLX. Microbiological analysis of the oropharyngeal biofilm and cost-effectiveness impact assessment will also be carried out.

Conditions

  • Oral Hygiene
  • Intensive Care
  • Chlorhexidine

Interventions

OTHER

Oral care

The intervention group procedure will be carried out in the same way and frequency of the control group, however, replacing the chlorhexidine solution 0.12% for mineral water. Oral hygiene will be carried out by the nursing team, which will be blind to the indices to be evaluated. The team will be previously trained to carry out hygiene procedures by the team of ICU dental surgeons.

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Fernanda de P Eduardo · Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453122 on ClinicalTrials.gov