Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients

NCT00123123 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2021-05-05

Study results available
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Summary

Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP).

The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.

Conditions

Interventions

DRUG

chlorhexidine gluconate oral rinse (0.12%)

chlorhexidine gluconate oral rinse

DRUG

placebo

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH
  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Frank A. Scannapieco, DMD PhD · University at Buffalo, The State University of New York

  • Frank A. Scannapieco, DMD PhD · The State University of New York

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00123123 on ClinicalTrials.gov