Reducing Risk for Infective Endocarditis

Recruiting now · Not applicable

Conditions studied: Bacteremia, Infective Endocarditis

In brief

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.

Key facts

Study ID

NCT05721781

Run by

Wake Forest University Health Sciences

People needed

320

Starts

2023-08-31

Expected to finish

2027-09-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Michigan School of Dentistry and Michigan Medicine — Ann Arbor, Michigan, United States (enrolling)
• Rutgers School of Dental Medicine — Newark, New Jersey, United States (enrolling)
• Atrium Health's Carolinas Medical Center — Charlotte, North Carolina, United States (enrolling)
• Tufts University School of Dental Medicine and Tufts University Health Sciences Campus — Boston, Massachusetts, United States
• New York University — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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