Overview

This trial has been completed.

Conditions pneumonia, respiratory infection
Treatments chlorhexidine, placebo mouthwash
Phase phase 1
Sponsor University of Louisville
Collaborator National Institute of Dental and Craniofacial Research (NIDCR)
Start date January 2006
End date July 2011
Trial size 75 participants
Trial identifier NCT00841074, DE015760, OGMB040944

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Peridex mouthwash
chlorhexidine Peridex
0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.
(Placebo Comparator)
Placebo mouthwash
placebo mouthwash Peridex mouthwash without chlorhexidine.
Placebo mouthwash spray application of ~1.3 ml twice a day.

Primary Outcomes

Measure
Pneumonia
time frame: 12 months

Secondary Outcomes

Measure
Respiratory pathogens
time frame: 12 months
Plaque and Gingival Indices
time frame: 12 months

Eligibility Criteria

Male or female participants at least 65 years old.

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.

Additional Information

Official title Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents
Principal investigator Catherine J Binkley, DDS, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Louisville.