NCT05721781 Reducing Risk for Infective Endocarditis
| NCT ID | NCT05721781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Bacteremia |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2023-08-31 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2023-08-31 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Peter Lockhart, DDS
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05721781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bacteremia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05721781 currently recruiting?
Yes, NCT05721781 is actively recruiting participants. Contact the research team at cathleen.petersen@atriumhealth.org for enrollment information.
Where is the NCT05721781 trial being conducted?
This trial is being conducted at Boston, United States, Ann Arbor, United States, Newark, United States, New York, United States and 2 additional locations.
Who is sponsoring the NCT05721781 clinical trial?
NCT05721781 is sponsored by Wake Forest University Health Sciences. The principal investigator is Peter Lockhart, DDS at Wake Forest University Health Sciences. The trial plans to enroll 320 participants.