Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
320 participants
INTERVENTIONAL
2023-08-31
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
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).
Dental Cleaning
Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.
Control
Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.
No interventions assigned to this group
Interventions
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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).
Dental Cleaning
Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Peter Lockhart, DDS
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
Boston, Massachusetts, United States
University of Michigan School of Dentistry and Michigan Medicine
Ann Arbor, Michigan, United States
Rutgers School of Dental Medicine
Newark, New Jersey, United States
New York University
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00092954
Identifier Type: -
Identifier Source: org_study_id
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