Reducing Risk for Infective Endocarditis
PIE-B
1 other identifier
interventional
320
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedStudy Start
First participant enrolled
August 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
August 22, 2025
August 1, 2025
4 years
January 31, 2023
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of bacteremia
Blood samples are assessed for positivity of Infective Endocarditis (IE) causing oral species. A participant is defined as having bacteremia at a visit if that participant has at least one blood draw positive for bacteremia of IE-causing species during or after tooth brushing, provided that those IE-causing species were not present at the pre-brushing blood draw.
Baseline
Incidence of bacteremia
Blood samples are assessed for positivity of Infective Endocarditis (IE) causing oral species. A participant is defined as having bacteremia at a visit if that participant has at least one blood draw positive for bacteremia of IE-causing species during or after tooth brushing, provided that those IE-causing species were not present at the pre-brushing blood draw.
Week 15
Secondary Outcomes (5)
Change in Incidence of bacteremia
Baseline to Week 3
Change in duration of bacteremia score
Baseline, Week 3, and Week 15
Change in calculus index scores
Baseline, Week 3, and Week 15
Change in visible plaque scores
Baseline, Week 3, and Week 15
Change in gingival index scores
Baseline, Week 3, and Week 15
Study Arms (2)
Participants receiving a dental cleaning and oral hygiene instruction
EXPERIMENTALParticipants randomized to this arm will receive a standard dental cleaning and education on proper toothbrushing and flossing technique and asked to follow these toothbrushing and flossing techniques for the duration of the study period. They will receive periodic phone call reminders to maintain these practices during the study period.
Control
NO INTERVENTIONParticipants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.
Interventions
Participants will be instructed on the Modified Bass technique for toothbrushing: brushing with a soft bristled toothbrush held at a 45 degree angle to the gums and brushed in a circular motion. Participants will also be instructed to floss at least once per day using floss or another inter-dental device (e.g., floss pick).
Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.
Eligibility Criteria
You may qualify if:
- Age 18 years or older.
- Greater than 6 months since last dental hygiene prophylaxis (cleaning).
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
Rutgers School of Dental Medicine
Newark, New Jersey, 07103, United States
New York University
New York, New York, 10010, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Lockhart, DDS
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 10, 2023
Study Start
August 31, 2023
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
August 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
A public use dataset will be available upon study completion.