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Reducing Risk for Infective Endocarditis (PIE-B)

Primary Purpose

Bacteremia, Infective Endocarditis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Hygiene instruction
Dental Cleaning
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacteremia focused on measuring Oral Hygiene, Oral Bacteria, Gingival inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
  • Brigham and Women's Hospital
  • University of Michigan School of Dentistry and Michigan Medicine
  • University of Rochester Medical Center
  • Atrium Health's Carolinas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Participants receiving a dental cleaning and oral hygiene instruction

Control

Arm Description

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.

Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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
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
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

Full Information

First Posted
January 31, 2023
Last Updated
October 3, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05721781
Brief Title
Reducing Risk for Infective Endocarditis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia, Infective Endocarditis
Keywords
Oral Hygiene, Oral Bacteria, Gingival inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants receiving a dental cleaning and oral hygiene instruction
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.
Intervention Type
Behavioral
Intervention Name(s)
Oral Hygiene instruction
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Dental Cleaning
Intervention Description
Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.
Primary Outcome Measure Information:
Title
Incidence of bacteremia
Description
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.
Time Frame
Baseline
Title
Incidence of bacteremia
Description
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.
Time Frame
Week 15
Secondary Outcome Measure Information:
Title
Change in Incidence of bacteremia
Description
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.
Time Frame
Baseline to Week 3
Title
Change in duration of bacteremia score
Description
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.
Time Frame
Baseline, Week 3, and Week 15
Title
Change in calculus index scores
Description
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
Time Frame
Baseline, Week 3, and Week 15
Title
Change in visible plaque scores
Description
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
Time Frame
Baseline, Week 3, and Week 15
Title
Change in gingival index scores
Description
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
Time Frame
Baseline, Week 3, and Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenene Noll, RN
Phone
704-355-9120
Email
jenene.noll@atriumhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Sullivan, MA
Phone
704-355-9496
Email
kathleen.sullivan@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lockhart, DDS
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Tzavaras
Email
elizabeth.tzavaras@tufts.edu
First Name & Middle Initial & Last Name & Degree
Vidya Sankar, DMD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Keates
Email
rkeates@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kenneth Ikeda, DDS, MPH
Facility Name
University of Michigan School of Dentistry and Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyran Groce
Email
kyrang@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Munz, DDS
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Thomas
Email
Victoria_Thomas@URMC.Rochester.edu
First Name & Middle Initial & Last Name & Degree
Sharon Elad, DMD
Facility Name
Atrium Health's Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenene Noll, RN
Phone
704-355-9120
Email
jenene.noll@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Joel J Napenas, DDS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A public use dataset will be available upon study completion.

Learn more about this trial

Reducing Risk for Infective Endocarditis

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