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Dental Care for Infective Endocarditis (PIE-B Trial)

N/A
Recruiting
Led By Peter Lockhart, DDS
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
10 or more accessible teeth (including implants, with a minimum of 8 natural teeth)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 3, and week 15
Awards & highlights

PIE-B Trial Summary

This trial tests if a dental cleaning and better oral hygiene can prevent bacteria in the bloodstream. Two groups compare results to see if it works.

Who is the study for?
This trial is for adults over 18 who haven't had a dental cleaning in the last 6 months, have at least 10 teeth, and can follow study rules. It's not for pregnant women or those with conditions like clotting disorders, drug use, transplants, ongoing cancer treatment, recent antibiotics use, orthodontic braces, or high risk of infective endocarditis.Check my eligibility
What is being tested?
Researchers are testing if dental cleanings and better brushing education can prevent bacteria from entering the bloodstream after toothbrushing. Participants will be split into two groups: one receiving dental care and instructions; the other won't to compare blood test results.See study design
What are the potential side effects?
There may not be direct side effects from participating in this trial since it involves standard oral hygiene practices. However, there could be discomfort during dental cleaning or when learning new brushing techniques.

PIE-B Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
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I have at least 10 teeth or implants, with 8 being my own natural teeth.

PIE-B Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 3, and week 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 3, and week 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of bacteremia
Secondary outcome measures
Change in Incidence of bacteremia
Change in calculus index scores
Change in duration of bacteremia score
+2 more

PIE-B Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving a dental cleaning and oral hygiene instructionExperimental Treatment2 Interventions
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.
Group II: ControlActive Control1 Intervention
Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dental Cleaning
2016
N/A
~50

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,003,917 Total Patients Enrolled
Peter Lockhart, DDSPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Dental Cleaning Clinical Trial Eligibility Overview. Trial Name: NCT05721781 — N/A
Bacterial Blood Infection Research Study Groups: Participants receiving a dental cleaning and oral hygiene instruction, Control
Bacterial Blood Infection Clinical Trial 2023: Dental Cleaning Highlights & Side Effects. Trial Name: NCT05721781 — N/A
Dental Cleaning 2023 Treatment Timeline for Medical Study. Trial Name: NCT05721781 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unclaimed slots remaining in this clinical research project?

"Clinicaltrials.gov specifies that this particular medical experiment is not currently recruiting volunteers, despite the fact it was first posted on April 1st of 2023 and last updated a month ago in January 2021. Fortunately, there are 46 other clinical trials presently open for enrollment."

Answered by AI

Who else is applying?

What site did they apply to?
Atrium Health's Carolinas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Reducing Risk for Infective Endocarditis
2023. "Reducing Risk for Infective Endocarditis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05721781.
~213 spots leftby Sep 2027
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