Reducing Risk for Infective Endocarditis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Oral Hygiene instruction
BehavioralParticipants 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/SurgeryParticipants will receive a dental cleaning according to the current standard of care for routine dental cleanings.
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: Participants receiving a dental cleaning and oral hygiene instructionExperimental treatment 2 interventions
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Week 15Secondary outcomes
1
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.
Time frame
Baseline to Week 32
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.
Time frame
Baseline, Week 3, and Week 153
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
Time frame
Baseline, Week 3, and Week 154
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
Time frame
Baseline, Week 3, and Week 15Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov