Reducing Risk for Infective Endocarditis

Conditions

• Bacteremia
• Infective Endocarditis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Oral Hygiene instruction — BEHAVIORAL
  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 — PROCEDURE
  Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.

Study Details

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.

Key Dates

Start date

Aug 31, 2023

Status verified

Aug 2025

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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.

Primary Outcome Measure

Incidence of bacteremia [ Time Frame: Baseline ]

Central Contacts

• Cathy Petersen, RDH
  704-355-1494
  [email protected]
• Kate Sullivan, MA
  704-355-9496
  [email protected]

Locations (6)

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