Improving oral hygiene to reduce risk of infective endocarditis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether improving oral hygiene through dental cleaning and education can reduce the presence of bacteria in the bloodstream that may lead to infective endocarditis. Participants will be randomly assigned to receive either a dental cleaning and oral health instructions or routine care. Blood samples will be collected before and after brushing to assess the impact of the intervention on bacteremia. The study aims to provide insights that could change prevention guidelines for individuals at risk of infective endocarditis.

Why it matters

Who can join: the full rules

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 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's running

• University of Michigan School of Dentistry and Michigan Medicine
  Ann Arbor, Michigan, United States Recruiting
• Rutgers School of Dental Medicine
  Newark, New Jersey, United States Recruiting
• Atrium Health's Carolinas Medical Center
  Charlotte, North Carolina, United States Recruiting
• Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
  Boston, Massachusetts, United States Withdrawn
• New York University
  New York, New York, United States Not yet recruiting
• University of Rochester Medical Center
  Rochester, New York, United States Completed

Study contacts

• Principal investigator: Peter Lockhart, DDS — Wake Forest University Health Sciences
• Study coordinator: Cathy Petersen, RDH
• Email: cathleen.petersen@atriumhealth.org
• Phone: 704-355-1494

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.