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Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT00123123
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : September 9, 2010
Last Update Posted : September 9, 2010
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
State University of New York at Buffalo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition Pneumonia
Interventions Drug: chlorhexidine gluconate oral rinse (0.12%)
Drug: placebo
Enrollment 175
Recruitment Details Subjects were recruited from 1 March, 2004 until 30 November, 2007. Subjects were recruited from patients admitted to the ICU of the Erie County Medical Center (ECMC) who were mechanically ventilated. This ICU provides trauma, burn care, and rehabilitation and is an affiliated teaching facility for the State University of New York at Buffalo.
Pre-assignment Details  
Arm/Group Title Placebo Chlorhexidine/Placebo Chlorhexidine
Hide Arm/Group Description Vehicle control twice a day (oral rinse) Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day chlorhexidine 1 oz oral rinse twice a day
Period Title: Overall Study
Started 59 58 58
Completed 59 58 58
Not Completed 0 0 0
Arm/Group Title Placebo Chlorhexidine/Placebo Chlorhexidine Total
Hide Arm/Group Description Vehicle control twice a day (oral rinse) Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day chlorhexidine 1 oz oral rinse twice a day Total of all reporting groups
Overall Number of Baseline Participants 59 58 58 175
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 58 participants 175 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
59
 100.0%
58
 100.0%
58
 100.0%
175
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 58 participants 58 participants 175 participants
50.0  (22.5) 44.8  (19.9) 47.6  (19.1) 48.0  (20.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 58 participants 175 participants
Female
23
  39.0%
15
  25.9%
14
  24.1%
52
  29.7%
Male
36
  61.0%
43
  74.1%
44
  75.9%
123
  70.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants 58 participants 58 participants 175 participants
59 58 58 175
1.Primary Outcome
Title Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours
Hide Description Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide. Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli). Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.
Time Frame Every 48 hours until discharge
Hide Outcome Measure Data
Hide Analysis Population Description
All tests were carried out using intent-to-treat analysis, with two-sided tests with a significance level of 0.05. Baseline comparisons between groups were made by analysis of variance (ANOVA) and/or the chi-squared test, as appropriate.
Arm/Group Title Placebo Chlorhexidine/Placebo Chlorhexidine
Hide Arm/Group Description:
Vehicle control twice a day (oral rinse)
Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
chlorhexidine 1 oz oral rinse twice a day
Overall Number of Participants Analyzed 59 58 58
Mean (Standard Deviation)
Unit of Measure: CFU/mL
7  (2) 7.1  (1.9) 5.1  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Chlorhexidine/Placebo, Chlorhexidine
Comments A mixed effect model was used to compare overall treatment effects between groups for repeated measures data. The group comparison for each time point was performed using ANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6750
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Clinical Pulmonary Infection Score (CPIS) at 48 Hours
Hide Description

The CPIS score was calculated as follows: 1) Fever: 0 (36.5 to 38.4°C), 1 (38.5 to 39), 2 (<36.0 OR >39.0); 2) Leukocytosis: 0 (4000 to 11,000 white blood cells per mm3 of blood), 1 (11,000 to 17,000), 2 (>17,000); 3) New infiltrate:

0 = None, 1 = Patchy, 2 = Localized; 4) Secretions: 0 = None to minimal, 1 = moderate, 2 = large amount; and 5) PaO2/ FiO2: 0 = more than 330 and 2 = less than 330. Total scores for the subscales can range from 0-10, with lower scores indicating better outcome.

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Chlorhexidine/Placebo Chlorhexidine
Hide Arm/Group Description:
Vehicle control twice a day (oral rinse)
Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
chlorhexidine 1 oz oral rinse twice a day
Overall Number of Participants Analyzed 59 58 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.5  (1) 2.5  (0.9) 2.4  (1)
Time Frame Patients were followed until discharge from the intensive care unit
Adverse Event Reporting Description The numbers of participants at risk do not match numbers of participants provided in the participant flow module since some patients exited study before 48 hour assessment point.
 
Arm/Group Title Placebo Chlorhexidine/Placebo Chlorhexidine
Hide Arm/Group Description Vehicle control twice a day (oral rinse) Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day chlorhexidine 1 oz oral rinse twice a day
All-Cause Mortality
Placebo Chlorhexidine/Placebo Chlorhexidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Chlorhexidine/Placebo Chlorhexidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/47 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Chlorhexidine/Placebo Chlorhexidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/47 (0.00%)   0/50 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Frank A. Scannapieco
Organization: University at Buffalo
Phone: 716-829-3373
Responsible Party: Frank A Scannapieco, DMD, Ph.D, University of Buffalo
ClinicalTrials.gov Identifier: NCT00123123     History of Changes
Other Study ID Numbers: NIDCR-14685
R01DE014685 ( U.S. NIH Grant/Contract )
1R01-DE-14685-1A2
First Submitted: July 21, 2005
First Posted: July 22, 2005
Results First Submitted: August 12, 2010
Results First Posted: September 9, 2010
Last Update Posted: September 9, 2010