Reducing Risk for Infective Endocarditis

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to see if getting a dental cleaning and learning better ways to brush and care for teeth can help reduce the amount of bacteria in the bloodstream after brushing. The study is focused on adults aged 18 and older who have not had a dental cleaning in the last six months and have at least 10 teeth. Some participants will receive a dental cleaning and oral health education, while others will not. Researchers will then compare the blood test results from both groups to find out if the education and cleaning helped keep bacteria levels lower.

If you decide to participate, you’ll need to be willing to go without regular dental cleanings while in the study. It’s important to note that some people are not eligible, such as those with certain heart conditions or those currently using antibiotics. This trial is a chance to help improve dental health practices and potentially reduce the risk of infections like infective endocarditis, which can be serious.

Gender

ALL

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.