Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
232 participants
INTERVENTIONAL
2014-12-31
2018-03-20
Brief Summary
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Detailed Description
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Information will be collected will include clinical condition, medications, age, gender, and smoking status. Once every day, digital pictures will be taken of each tooth (takes approximately five minutes) using a small intraoral camera to be evaluated for plaque by a dental hygienist that is blinded to frequency group assignment. Once every day, gingival crevicular fluid samples (takes 30 seconds) to look for factors that predict infection.
Gingival crevicular fluid samples and digital pictures of the teeth will also be collected on day 1, day 3 and day 5 after extubation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Frequency of Once a Day
Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours)
Tooth Brushing Protocol
A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.
Frequency of Twice a Day
Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours) Tooth Brushing Protocol to be provided at 1:00 pm (+/- 1.5 hours)
Tooth Brushing Protocol
A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.
Frequency of Three Times a Day
Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours) Tooth Brushing Protocol to be provided at 1:00 pm (+/- 1.5 hours) Tooth Brushing Protocol to be provided at 6:00 pm (+/- 1.5 hours)
Tooth Brushing Protocol
A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.
Interventions
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Tooth Brushing Protocol
A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.
Eligibility Criteria
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Inclusion Criteria
* have at least one tooth, and
* they or their legally authorized representative are able to provide informed consent in English or Spanish.
Exclusion Criteria
* medical contraindication to tooth brushing.
18 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Tampa General Hospital
OTHER
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Cindy L Munro, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Kevin E Kip, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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Tampa General Hospital
Tampa, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PRO 00016479
Identifier Type: -
Identifier Source: org_study_id
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