Reducing Risk for Infective Endocarditis

Description

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.

Conditions

Bacteremia, Infective Endocarditis

Study Overview

Study Details

Study overview

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.

Reducing Risk for Infective Endocarditis (IE): A Randomized Trial of a Professional Scaling and Oral Hygiene Instruction Intervention to Reduce Tooth Brushing-Associated Bacteremia

Reducing Risk for Infective Endocarditis

Condition
Bacteremia
Intervention / Treatment

-

Contacts and Locations

Boston

Tufts University School of Dental Medicine and Tufts University Health Sciences Campus, Boston, Massachusetts, United States, 02111

Ann Arbor

University of Michigan School of Dentistry and Michigan Medicine, Ann Arbor, Michigan, United States, 48109

Rochester

University of Rochester Medical Center, Rochester, New York, United States, 14620

Charlotte

Atrium Health's Carolinas Medical Center, Charlotte, North Carolina, United States, 28203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Wake Forest University Health Sciences,

Peter Lockhart, DDS, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2027-09