BacteremiaPIE-BNCT05721781
Reducing Risk for Infective Endocarditis
A study testing Oral Hygiene instruction and Dental Cleaning in people with Bacteremia and Infective Endocarditis, run by Wake Forest University Health Sciences at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacteremia, Infective Endocarditis
- What is being tested?
- Oral Hygiene instruction and Dental Cleaning
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Aug 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 4 recruiting
- Recruiting
University of Michigan School of Dentistry and Michigan Medicine
Ann Arbor, Michigan, 48109
Mary Burton, mjburt@med.umich.edu
Stephanie Munz, DDS
- Withdrawn
Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
Boston, Massachusetts, 02111
- Recruiting
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, 28203
Cathleen Petersen, RDH, 704-355-1494, cathleen.petersen@atriumhealth.org
Joel J Napenas, DDS
- Not yet recruiting
New York University
New York, New York, 10010
Leticia Arbex, 212-998-9800, la1669@nyu.edu
Mariana Bucovsky, mb10357@nyu.edu
- Recruiting
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
Reena Antony, 973-972-7224, rantony@sdm.rutgers.edu
Vamshi Gajjala, 240-782-5055, vg559@shp.rutgers.edu
- Completed
University of Rochester Medical Center
Rochester, New York, 14620
About this study
Official title: 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.
Read the 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.
- Conditions
- Bacteremia, Infective Endocarditis
- Being tested
- Oral Hygiene instruction, Dental Cleaning
- Keywords
- Oral Hygiene, Oral Bacteria, Gingival inflammation
- Medical subject headings
- Bacteremia, Endocarditis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Hygiene instructionBehavioural
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).
Dental CleaningProcedure or surgery
Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving a dental cleaning and oral hygiene instruction | Experimental | 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. Receives: Behavioral: Oral Hygiene instruction; Procedure: Dental Cleaning |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 15
Secondary outcomes (5)
Change in 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.
Measured: Baseline to Week 3
Change in duration of bacteremia score
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.
Measured: Baseline, Week 3, and Week 15
Change in calculus index scores
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
Measured: Baseline, Week 3, and Week 15
Change in visible plaque scores
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
Measured: Baseline, Week 3, and Week 15
Change in gingival index scores
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
Measured: Baseline, Week 3, and Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start31 Aug 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Lockhart, DDS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721781
- Sponsor's protocol ID
- IRB00092954
- Acronym
- PIE-B
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A public use dataset will be available upon study completion.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Risk for Infective Endocarditis (IE): A Randomized Trial of a Professional Scaling and Oral Hygiene Instruction Intervention to Reduce Tooth Brushing-Associated Bacteremia
- ClinicalTrials.gov ID
- NCT05721781
- Acronym / sponsor ID
- PIE-B / IRB00092954
- Conditions
- Bacteremia, Infective Endocarditis
- Keywords
- Oral Hygiene, Oral Bacteria, Gingival inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving a dental cleaning and oral hygiene instruction | Experimental | Behavioral: Oral Hygiene instruction, Procedure: Dental CleaningParticipants 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 intervention | –Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Hygiene instructionParticipants 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). | Behavioural | Participants receiving a dental cleaning and oral hygiene instruction |
| Dental CleaningParticipants will receive a dental cleaning according to the current standard of care for routine dental cleanings. | Procedure or surgery | Participants receiving a dental cleaning and oral hygiene instruction |
Primary outcome
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.
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.
5 secondary outcomes
Change in Incidence of bacteremia
Time frame: Baseline to Week 3
Change in duration of bacteremia score
Time frame: Baseline, Week 3, and Week 15
Change in calculus index scores
Time frame: Baseline, Week 3, and Week 15
Change in visible plaque scores
Time frame: Baseline, Week 3, and Week 15
Change in gingival index scores
Time frame: Baseline, Week 3, and Week 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. A public use dataset will be available upon study completion.
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THiamine for Recovery In Vulnerable Early-life Infections
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Lockhart, DDS principal investigator
Wake Forest University Health Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Hygiene instruction and Dental Cleaning in people with Bacteremia and Infective Endocarditis, run by Wake Forest University Health Sciences at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathy Petersen, RDH (704-355-1494, cathleen.petersen@atriumhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bacteremia (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.