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.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Hospital israelita Albert Einstein
RECRUITING
São Paulo
Contact Information
Primary
Fernanda P Eduardo, PhD
fpeduard@einstein.br
5511999037553
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 70
Treatments
Active_comparator: Chlorhexidine
patients with oral hygiene performed with tooth brushing and washing with 0.12% chlorhexidine
Sham_comparator: Water
patients with oral hygiene performed with tooth brushing and washing with filtered water.
Related Therapeutic Areas
Sponsors
Leads: Hospital Israelita Albert Einstein
Collaborators: University of Sao Paulo

This content was sourced from clinicaltrials.gov