Reducing Risk for Infective Endocarditis (PIE-B)

July 23, 2026 updated by: Wake Forest University Health Sciences

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This multi-center randomized clinical trial will determine if an intervention to improve oral hygiene and reduce gingival inflammation decreases the incidence and duration of bacteremia of Infective Endocarditis (IE) causing bacterial species, which may refocus longstanding guidelines on prevention for all people at risk for Infective Endocarditis (IE). The Standardized Brushing Hygienist will brush the participant's teeth over a 2-minute period, during and after which there will be 4 additional blood samples. The participant will then be randomized to an intervention or routine care group. The intervention will consist of a single session of tooth scaling and polishing, and oral hygiene instruction provided at the end of the Randomization Visit. Both groups will return for 3-week and 15-week visits, during which they will undergo a non-invasive oral examination and the brushing procedure with 5 blood samples (baseline and 4 additional blood samples after brushing begins). All blood samples will be cultured for bacteria of IE causing species.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Withdrawn
        • Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan School of Dentistry and Michigan Medicine
        • Principal Investigator:
          • Stephanie Munz, DDS
        • Contact:
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • Rutgers School of Dental Medicine
        • Contact:
        • Principal Investigator:
          • Georgios A. Kotsakis, DDS, MS, PhD
        • Contact:
    • New York
      • New York, New York, United States, 10010
        • Not yet recruiting
        • New York University
        • Contact:
        • Contact:
        • Principal Investigator:
          • R. Alexander Kerr
      • Rochester, New York, United States, 14620
        • Completed
        • University of Rochester Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Atrium Health's Carolinas Medical Center
        • Principal Investigator:
          • Joel J Napenas, DDS
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants receiving a dental cleaning and oral hygiene instruction
Participants 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.
Behavioral: Oral Hygiene instruction
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).
Procedure: Dental Cleaning
Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.
No Intervention: Control
Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of bacteremia
Time Frame: Baseline
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
Time Frame: Week 15
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Incidence of bacteremia
Time Frame: Baseline to Week 3
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 to Week 3
Change in duration of bacteremia score
Time Frame: Baseline, Week 3, and Week 15
At each visit, participants will have 5 blood samples drawn over the course of ~15 minutes. When a bacteremia occurs at a visit, its duration is defined as the last blood draw that tests positive for an IE-causing bacterial species that was not present at the pre-brushing draw. Possible values for duration are: 0 (no positive blood samples), 1 (only the blood draw during tooth brushing was positive), 2, 3, or 4, where the latter refer respectively to the subsequent blood samples.
Baseline, Week 3, and Week 15
Change in calculus index scores
Time Frame: Baseline, Week 3, and Week 15
The calculus index, defined as the average calculus score (0 to 3 scale) from 4 sites per tooth on all teeth in the dentition, will be measured at each visit - Calculus will be assessed using the index of Ramfjord - 0 = absence of signs of inflammation; 1 = mild to moderate inflammatory gingival changes, not extending around the tooth; 2 = mild to moderately severe gingivitis extending all around the tooth; 3 = severe gingivitis characterized by- marked redness, swelling, tendency to bleed and ulceration - higher scores denote worse changes
Baseline, Week 3, and Week 15
Change in visible plaque scores
Time Frame: Baseline, Week 3, and Week 15
The visible plaque score, defined as the percentage of surfaces with visible plaque across all teeth in the dentition, will be measured at each visit - Marginal dental plaque will be scored as visible or not visible using the criteria of Silness and Lӧe (1964) - Visible plaque corresponds to Silness and Lӧe scores of 2 and 3 - higher scores denote worse plaque
Baseline, Week 3, and Week 15
Change in gingival index scores
Time Frame: Baseline, Week 3, and Week 15
The gingival index, defined as the average gingival score (0 to 3 scale) from 4 sites per tooth on all teeth in the dentition, will be measured at each visit - Gingivitis will be assessed using the Gingival Index of Lӧe and Silness - A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation - higher scores denote increased inflammation
Baseline, Week 3, and Week 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Lockhart, DDS, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00092954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A public use dataset will be available upon study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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