Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients

NCT ID: NCT00123123

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2007-11-30

Brief 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.

Detailed Description

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. This pilot longitudinal, double blind intervention study will consider the appropriate frequency of delivery of CHX to improve oral hygiene in MV-ICU patients. Preliminary data from these pilot studies will also allow accurate sample size calculations to be made for a large-scale multi-center clinical trial; and 3) to perform molecular epidemiological studies to identify and genetically type bacteria cultured from lower airway secretions of MV-ICU patients with or without VAP and compare them to isolates of the same species from their dental plaque.

This pilot study will enable this multidisciplinary team of investigators to organize the infrastructure, patient recruitment and methodologic protocols, and data management and analysis procedures necessary to perform a multi-center, controlled clinical trial to assess the efficacy and generalizability of this intervention to improve oral hygiene in MV-ICU and prevent VAP.

Conditions

Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo (Vehicle Control)

Delivered Twice a day

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

0.12% chlorhexidine gluconate oral rinse

Delivered twice a day

Group Type: EXPERIMENTAL

chlorhexidine gluconate oral rinse (0.12%)

Intervention Type: DRUG

chlorhexidine gluconate oral rinse

0.12% chlorhexidine oral rinse

Delivered once a day, placebo once a day

Group Type: EXPERIMENTAL

chlorhexidine gluconate oral rinse (0.12%)

Intervention Type: DRUG

chlorhexidine gluconate oral rinse

placebo

Intervention Type: DRUG

Interventions

chlorhexidine gluconate oral rinse (0.12%)

chlorhexidine gluconate oral rinse

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Comatose and intubated patients will be included since they represent patients at greatest risk for respiratory infection.

• Patients for whom consent can not be obtained.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Frank Scannapieco

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank A. Scannapieco, DMD PhD

Role: STUDY_CHAIR

University at Buffalo, The State University of New York

Frank A. Scannapieco, DMD PhD

Role: PRINCIPAL_INVESTIGATOR

The State University of New York

Locations

University of Buffalo, The State University of New York

Buffalo, New York, United States

Countries

United States

References

Scannapieco FA, Yu J, Raghavendran K, Vacanti A, Owens SI, Wood K, Mylotte JM. A randomized trial of chlorhexidine gluconate on oral bacterial pathogens in mechanically ventilated patients. Crit Care. 2009;13(4):R117. doi: 10.1186/cc7967. Epub 2009 Jul 15.

Reference Type: RESULT

PMID: 19765321 (View on PubMed)

Heo SM, Haase EM, Lesse AJ, Gill SR, Scannapieco FA. Genetic relationships between respiratory pathogens isolated from dental plaque and bronchoalveolar lavage fluid from patients in the intensive care unit undergoing mechanical ventilation. Clin Infect Dis. 2008 Dec 15;47(12):1562-70. doi: 10.1086/593193.

Reference Type: RESULT

PMID: 18991508 (View on PubMed)

Other Identifiers

R01DE014685

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01-DE-14685-1A2

Identifier Type: -

Identifier Source: secondary_id

NIDCR-14685

Identifier Type: -

Identifier Source: org_study_id