Reducing Risk for Infective Endocarditis (IE): A Randomized Trial of a Professional Scaling and Oral Hygiene Instruction Intervention to Reduce Tooth Brushing-Associated Bacteremia

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Massachusetts
Tufts University School of Dental Medicine and Tufts University Health Sciences Campus
WITHDRAWN
Boston
Michigan
University of Michigan School of Dentistry and Michigan Medicine
RECRUITING
Ann Arbor
North Carolina
Atrium Health's Carolinas Medical Center
RECRUITING
Charlotte
New Jersey
Rutgers School of Dental Medicine
COMPLETED
Newark
New York
New York University
NOT_YET_RECRUITING
New York
University of Rochester Medical Center
ACTIVE_NOT_RECRUITING
Rochester
Contact Information
Primary
Cathy Petersen, RDH
cathleen.petersen@atriumhealth.org
704-355-1494
Backup
Kate Sullivan, MA
kathleen.sullivan@atriumhealth.org
704-355-9496
Time Frame
Start Date: 2023-08-31
Estimated Completion Date: 2027-09
Participants
Target number of participants: 320
Treatments
Experimental: 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.
No_intervention: Control
Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov