Reducing Risk for Infective Endocarditis
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
320 participants
Aug 31, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Age 18 years or older.
- Greater than 6 months since last dental hygiene prophylaxis (cleaning).
- 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 Criteria18
- At high risk for IE, as defined by the 2007/2021 AHA Guidelines:
- Prosthetic cardiac valve or prosthetic material used for cardiac valve repair.
- Previous episode of IE.
- Cardiac transplantation recipient with cardiac valvulopathy.
- Specific congenital heart disease conditions.
- Pregnant, by self-report, or planning to become pregnant during the study period.
- Affected by a condition that, in the opinion of the investigator, may preclude them from study completion or put them at increased risk such as :
- Hemodialysis dependent.
- Have a long-term intravascular catheter (e.g., for chemotherapy or parenteral nutrition).
- Active injection drug use (IDU).
- Clotting disorder such as, hemophilia.
- Have a solid organ transplant or hematopoietic stem cell transplant, or ongoing treatment for hematologic cancer.
- Currently incarcerated.
- Systemic antibiotic use within the past 2 weeks.
- Undergoing orthodontic treatment with fixed appliances (brackets and wires) or plans to do so during the study period.
- Taking or requiring antibiotic prophylaxis prior to dental procedures for other reasons, e.g., to prevent prosthetic joint infection .
- Three or more teeth with moderate to severe gingival hyperplasia.
- Has clinically detectable emergent or urgent dental needs that, in the trained and calibrated Oral Examiner's opinion, would require definitive dental care during the study period.
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Interventions
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).
Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05721781