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Chlorhexidine & Pneumonia in Nursing Home Residents

This study has been completed.
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Catherine J Binkley, University of Louisville Identifier:
First received: February 9, 2009
Last updated: April 12, 2017
Last verified: December 2016
The purpose of this study is determine if topical oral application of a chlorhexidine antimicrobial spray will significantly reduce pneumonia and respiratory infections, and improve oral health compared to a placebo solution in nursing home residents.

Condition Intervention Phase
Respiratory Infection
Drug: chlorhexidine
Drug: Placebo mouthwash
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents

Resource links provided by NLM:

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Pneumonia [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Respiratory pathogens [ Time Frame: 12 months ]
  • Plaque and Gingival Indices [ Time Frame: 12 months ]

Enrollment: 75
Study Start Date: January 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Peridex mouthwash
Drug: chlorhexidine
0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.
Other Name: Peridex
Placebo Comparator: 2
Placebo mouthwash
Drug: Placebo mouthwash
Placebo mouthwash spray application of ~1.3 ml twice a day.
Other Name: Peridex mouthwash without chlorhexidine.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Participants must be at least 65 years old.
  2. Be dependent in 2 or more Activities of Daily Living as noted on the nursing home resident's Minimum Data Set - One must be ADL J- Personal Hygiene.
  3. Have natural teeth and/or wear complete or partial dentures.
  4. Expected to be a resident in a nursing home for two years.

Exclusion Criteria:

  1. Existing pneumonia.
  2. History of chlorhexidine reaction or allergy and/or multiple medication or substance allergies.
  3. Receiving chlorhexidine oral application at enrollment as prescribed by physician or dentist.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00841074

United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Catherine J Binkley, DDS, PhD University of Louisville
  More Information

Responsible Party: Catherine J Binkley, PI, University of Louisville Identifier: NCT00841074     History of Changes
Other Study ID Numbers: OGMB040944
Study First Received: February 9, 2009
Last Updated: April 12, 2017

Keywords provided by University of Louisville:
Respiratory pathogens

Additional relevant MeSH terms:
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Disinfectants processed this record on May 25, 2017