Reducing Risk for Infective Endocarditis
Start Date
8/31/2023
Completion Date
9/1/2027
Summary
This clinical trial is studying if bacteria found in a participant's bloodstream after brushing their teeth can be prevented with a dental cleaning and more education on how to best brush and care for their teeth. One group of participants will have a dental cleaning and oral health instructions and the other group of participants will not. Researchers will compare the blood test results from the two groups to see if the education made a difference in preventing bacteria and how long it stays in the bloodstream.
Detailed Description
This multi-center randomized clinical trial will determine if an intervention to improve oral hygiene and reduce gingival inflammation decreases the incidence and duration of bacteremia of Infective Endocarditis (IE) causing bacterial species, which may refocus longstanding guidelines on prevention for all people at risk for Infective Endocarditis (IE). The Standardized Brushing Hygienist will brush the participant's teeth over a 2-minute period, during and after which there will be 4 additional blood samples. The participant will then be randomized to an intervention or routine care group. The intervention will consist of a single session of tooth scaling and polishing, and oral hygiene instruction provided at the end of the Randomization Visit. Both groups will return for 3-week and 15-week visits, during which they will undergo a non-invasive oral examination and the brushing procedure with 5 blood samples (baseline and 4 additional blood samples after brushing begins). All blood samples will be cultured for bacteria of IE causing species.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Oral Hygiene instruction
Dental Cleaning
Conditions
Locations
Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
Boston, Massachusetts 02111
United States
University of Michigan School of Dentistry and Michigan Medicine
Ann Arbor, Michigan 48109
United States
Rutgers School of Dental Medicine
Newark, New Jersey 07103
United States
New York University
New York, New York 10010
United States
University of Rochester Medical Center
Rochester, New York 14620
United States
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina 28203
United States