Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05721781

Conditions

Bacteremia

Infective Endocarditis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Oral Hygiene instruction

Dental Cleaning

Study Details

Brief 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.

Conditions

Bacteremia

Infective Endocarditis

Study ID

NCT05721781

Start date

Aug 31, 2023

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 the study.
  • Willing to forgo routine professional dental cleanings while enrolled in the trial.

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 them from study completion or put them at increased risk such as :
  • Hemodialysis dependent.
  • Have a long-term intravascular catheter (e.g., for chemotherapy or parenteral nutrition).
  • Active injection drug use (IDU).
  • Clotting disorder such as, hemophilia.
  • Have a solid organ transplant or hematopoietic stem cell transplant, or ongoing treatment for hematologic cancer.
  • Currently incarcerated.
  • Systemic antibiotic use within the past 2 weeks.
  • Undergoing orthodontic treatment with fixed appliances (brackets and wires) or plans to do so during the study period.
  • Taking or requiring antibiotic prophylaxis prior to dental procedures for other reasons, 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 and calibrated Oral Examiner's opinion, would require definitive dental care during the study period.

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Oral Hygiene instruction

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

Participants will receive a dental cleaning according to the current standard of care for routine dental cleanings.

Primary outcome measure

  • Incidence of bacteremia [ Time Frame: Baseline ]
  • Incidence of bacteremia [ Time Frame: Week 15 ]

Central Contacts and Locations

Central contacts

Cathy Petersen, RDH

704-355-1494cathleen.petersen@atriumhealth.org

Kate Sullivan, MA

704-355-9496kathleen.sullivan@atriumhealth.org

Locations

University of Michigan School of Dentistry and Michigan Medicine

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Mary Burton

mjburt@med.umich.edu

Principal Investigator:

Stephanie Munz, DDS

Rutgers School of Dental Medicine

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Reena Antony

973-972-7224rantony@sdm.rutgers.edu

Vamshi Gajjala

240-782-5055vg559@shp.rutgers.edu

Principal Investigator:

Georgios A. Kotsakis, DDS, MS, PhD

Atrium Health's Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Cathleen Petersen, RDH

704-355-1494cathleen.petersen@atriumhealth.org

Principal Investigator:

Joel J Napenas, DDS

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Oral Hygiene
  • Oral Bacteria
  • Gingival inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-24.