Strategies to Prevent Pneumonia (SToP Pneumonia)
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ClinicalTrials.gov Identifier: NCT00234598 |
Recruitment Status :
Completed
First Posted : October 7, 2005
Last Update Posted : December 8, 2015
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Condition or disease | Intervention/treatment | Phase |
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Ventilator Associated Pneumonia | Procedure: Toothbrushing only Procedure: Chlorhexidine only Procedure: Toothbrushing and Chlorhexidine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 547 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double (Care Provider, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Oral Care Intervention in Mechanically Ventilated Adults |
Study Start Date : | March 2002 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
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No Intervention: Control group, usual care
Usual care with no study interventions provided; no tooth brushing intervention and no chlorhexidine intervention. Usual care
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Active Comparator: Tooth brushing only
Tooth brushing by study personnel three times per 24 hours (TID) without chlorhexidine application.
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Procedure: Toothbrushing only
Toothbrushing three times per 24 hours without chlorhexidine |
Active Comparator: Chlorhexidine only
Oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID) without tooth brushing.
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Procedure: Chlorhexidine only
Chlorhexidine oral rinse twice per 24 hours without toothbrushing |
Active Comparator: Toothbrushing and chlorhexidine
Tooth brushing by study personnel three times per 24 hours (TID) and oral application of chlorhexidine 0.12% oral solution twice per 24 hours (BID)
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Procedure: Toothbrushing and Chlorhexidine
Toothbrushing three times per 24 hours plus chlorhexidine twice per 24 hours. |
- Reduction of build-up of dental plaque on the teeth and reduced risk of pneumonia in critical care patients, as a result of special oral care provided by nurses. [ Time Frame: 7 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years or older, admitted to one of four intensive care units at the study hospital, breathing tube in place, and on a breathing machine (mechanical ventilator)
Exclusion Criteria:
- Breathing tube in place for more than 24 hours prior to entry into the study, absence of teeth, or a medical diagnosis of pneumonia when the breathing tube is put in.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234598
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23284 |
Principal Investigator: | Cindy Munro, RN, ANP,PhD | Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00234598 |
Other Study ID Numbers: |
VCU1006 R01NR007652 ( U.S. NIH Grant/Contract ) R01 NR07652 (NIH) |
First Posted: | October 7, 2005 Key Record Dates |
Last Update Posted: | December 8, 2015 |
Last Verified: | December 2015 |
Pneumonia Dental Health Critical Care |
Pneumonia, Ventilator-Associated Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection |
Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Dermatologic Agents |