Reducing Risk for Infective Endocarditis

Bacteremia Clinical Trial

— PIE-B  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721781
• Other study ID #: IRB00092954
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: September 2027

Study information

• Verified date: October 2023
• Source: Wake Forest University Health Sciences
• Contact: Cathy Petersen, RDH
• Phone: 704-355-1494
• Email: cathleen.petersen[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry and Michigan Medicine	Ann Arbor	Michigan
United States	Tufts University School of Dental Medicine and Tufts University Health Sciences Campus	Boston	Massachusetts
United States	Atrium Health's Carolinas Medical Center	Charlotte	North Carolina
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline to Week 3
Secondary	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.	Baseline, Week 3, and Week 15
Secondary	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	Baseline, Week 3, and Week 15
Secondary	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 L?e (1964) - Visible plaque corresponds to Silness and L?e scores of 2 and 3 - higher scores denote worse plaque	Baseline, Week 3, and Week 15
Secondary	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 L?e 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