Phase
Condition
Soft Tissue Infections
Heart Disease
Cardiovascular Disease
Treatment
Oral Hygiene instruction
Dental Cleaning
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 thestudy.
Willing to forgo routine professional dental cleanings while enrolled in the trial.
Exclusion
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 themfrom study completion or put them at increased risk such as :
Hemodialysis dependent.
Have a long-term intravascular catheter (e.g., for chemotherapy or parenteralnutrition).
Active injection drug use (IDU).
Clotting disorder such as, hemophilia.
Have a solid organ transplant or hematopoietic stem cell transplant, or ongoingtreatment for hematologic cancer.
Currently incarcerated.
Systemic antibiotic use within the past 2 weeks.
Undergoing orthodontic treatment with fixed appliances (brackets and wires) or plansto do so during the study period.
Taking or requiring antibiotic prophylaxis prior to dental procedures for otherreasons, 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 andcalibrated Oral Examiner's opinion, would require definitive dental care during thestudy period.
Study Design
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
Boston, Massachusetts 02111
United StatesSite Not Available
University of Michigan School of Dentistry and Michigan Medicine
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Rutgers School of Dental Medicine
Newark, New Jersey 07103
United StatesActive - Recruiting
University of Rochester Medical Center
Rochester, New York 14620
United StatesSite Not Available
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesActive - Recruiting
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