Reducing Risk for Infective Endocarditis (IE): A Randomized Trial of a Professional Scaling and Oral Hygiene Instruction Intervention to Reduce Tooth Brushing-Associated Bacteremia
Wake Forest University Health Sciences
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.
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. Th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age 18 years or older. * Greater than 6 months since last dental hygiene prophylaxis (cleaning). * 10 or more accessible teeth (including implants, with a minimum of 8 natural teeth). * Willing and able to provide informed consent. * Willing to comply with all study procedures and be available for the duration of the study. * Willing to forgo routine professional dental cleanings while enrolled in the trial. Exclusion Criteria: * At high risk for IE, as defined by the 2007/2021 AHA Guidelines: * Prosthetic cardiac valve or prosthetic material used for cardiac valve rep…
Interventions
- BehavioralOral Hygiene instruction
Participants will be instructed on the Modified Bass technique for toothbrushing: brushing with a soft bristled toothbrush held at a 45 degree angle to the gums and brushed in a circular motion. Participants will also be instructed to floss at least once per day using floss or another inter-dental device (e.g., floss pick).
- ProcedureDental Cleaning
Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.
Locations (6)
- Tufts University School of Dental Medicine and Tufts University Health Sciences CampusBoston, Massachusetts
- University of Michigan School of Dentistry and Michigan MedicineAnn Arbor, Michigan
- Rutgers School of Dental MedicineNewark, New Jersey
- New York UniversityNew York, New York
- University of Rochester Medical CenterRochester, New York
- Atrium Health's Carolinas Medical CenterCharlotte, North Carolina