Improving oral hygiene to reduce risk of infective endocarditis
Reducing Risk for Infective Endocarditis (IE): A Randomized Trial of a Professional Scaling and Oral Hygiene Instruction Intervention to Reduce Tooth Brushing-Associated Bacteremia
This study tests if better oral hygiene, through dental cleaning and education, can help reduce bacteria in the blood for people at risk of infective endocarditis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Boston, Massachusetts and 5 other locations) |
| Trial ID | NCT05721781 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have not had a dental cleaning in over six months and have at least ten accessible teeth.
Not a fit: Patients at high risk for infective endocarditis, such as those with prosthetic heart valves or previous episodes of the condition, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of infective endocarditis by promoting better oral hygiene practices.
How similar studies have performed: Other studies have explored the relationship between oral hygiene and systemic infections, suggesting potential benefits, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 5 other locations
- Tufts University School of Dental Medicine and Tufts University Health Sciences Campus — Boston, Massachusetts, United States (Withdrawn)
- 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 (Completed)
- New York University — New York, New York, United States (Not_yet_recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Active_not_recruiting)
- Atrium Health's Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.