RECRUITING

Reducing Risk for Infective Endocarditis

Talk to us

Conditions

BacteremiaInfective EndocarditisOral HygieneOral BacteriaGingival inflammation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-31
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05721781

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older.
  2. * Greater than 6 months since last dental hygiene prophylaxis (cleaning).
  3. * 10 or more accessible teeth (including implants, with a minimum of 8 natural teeth).
  4. * Willing and able to provide informed consent.
  5. * Willing to comply with all study procedures and be available for the duration of the study.
  6. * Willing to forgo routine professional dental cleanings while enrolled in the trial.
  1. * At high risk for IE, as defined by the 2007/2021 AHA Guidelines:
  2. * Prosthetic cardiac valve or prosthetic material used for cardiac valve repair.
  3. * Previous episode of IE.
  4. * Cardiac transplantation recipient with cardiac valvulopathy.
  5. * Specific congenital heart disease conditions.
  6. * Pregnant, by self-report, or planning to become pregnant during the study period.
  7. * 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 :
  8. * Hemodialysis dependent.
  9. * Have a long-term intravascular catheter (e.g., for chemotherapy or parenteral nutrition).
  10. * Active injection drug use (IDU).
  11. * Clotting disorder such as, hemophilia.
  12. * Have a solid organ transplant or hematopoietic stem cell transplant, or ongoing treatment for hematologic cancer.
  13. * Currently incarcerated.
  14. * Systemic antibiotic use within the past 2 weeks.
  15. * Undergoing orthodontic treatment with fixed appliances (brackets and wires) or plans to do so during the study period.
  16. * Taking or requiring antibiotic prophylaxis prior to dental procedures for other reasons, e.g., to prevent prosthetic joint infection .
  17. * Three or more teeth with moderate to severe gingival hyperplasia.
  18. * 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.

Contacts and Locations

Study Contact

Cathy Petersen, RDH
CONTACT
704-355-1494
cathleen.petersen@atriumhealth.org
Kate Sullivan, MA
CONTACT
704-355-9496
kathleen.sullivan@atriumhealth.org

Principal Investigator

Peter Lockhart, DDS
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
Boston, Massachusetts, 02111
United States
University of Michigan School of Dentistry and Michigan Medicine
Ann Arbor, Michigan, 48109
United States
University of Rochester Medical Center
Rochester, New York, 14620
United States
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, 28203
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-31
Study Completion Date2027-09

Study Record Updates

Study Start Date2023-08-31
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Oral Hygiene
  • Oral Bacteria
  • Gingival inflammation

Additional Relevant MeSH Terms

  • Bacteremia
  • Infective Endocarditis