NCT00454285

Brief Summary

The major purposes of this prospective, randomized, clinical study are to:

  1. 1.Determine and compare the true incidence, nature, magnitude, and duration (INMD) of bacteremia (bacteria found in the bloodstream) resulting from a highly invasive dental office procedure (tooth extraction) and a minimally invasive and naturally occurring source of bacteremia (tooth brushing);
  2. 2.Measure the effect of the American Heart Association's guidelines for amoxicillin prophylaxis (preventive treatment) on the INMD of bacteremia resulting from a single tooth extraction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
Last Updated

April 25, 2022

Status Verified

December 1, 2009

Enrollment Period

2.8 years

First QC Date

March 29, 2007

Last Update Submit

April 19, 2022

Conditions

Bacteremia

Keywords

bacteremia,cultures, infective endocarditis, prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Overall incidence of bacteremia in three groups

    Blood Draws at 0, 2.5, and 5 minutes; and at 20. 40, and 60 minutes.

Interventions

Effect of Amoxicillin on bacteremia following a single-tooth extractionDRUG

Administer Amoxicillin 1 hour prior to single-tooth extraction.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have at least 10 teeth and the need for a dental extraction.
  • Subjects will be accepted into the study regardless of the extent of their odontogenic and/or periodontal disease, to include Type I through IV American Association of Periodontists classification.

You may not qualify if:

  • Subjects who need surgical extractions that require initial removal of bone overlying the surface of a tooth.
  • Subjects who have taken systemic antibiotics within the previous 2 weeks.
  • Subjects who require antibiotic coverage, based on current practice guidelines, prior to invasive dental procedures (e.g., cardiac valve abnormalities).
  • Subjects with active viral infectious disease (e.g., hepatitis).
  • Subjects who are immunocompromised (e.g., organ transplant, HIV).
  • Subjects classified as American Society of Anesthesiology Class III or higher (i.e., a patient with poorly-controlled systemic disease).
  • Subjects with facial cellulitis.
  • Subjects who have had any manipulation of the gingiva within 1 hr prior to the study(e.g., eating, tooth brushing, chewing gum).
  • Subjects with a history of penicillin allergy.
  • Subjects deemed by the clinician to have a bacterial infection.
  • Subjects with a temperature of 100.5 degrees Fahrenheit or above.
  • Venous access unavailable in non-dominant arm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center Dental Clinic

Charlotte, North Carolina, 28203, United States

Location

Related Publications (1)

  • Lockhart PB, Brennan MT, Thornhill M, Michalowicz BS, Noll J, Bahrani-Mougeot FK, Sasser HC. Poor oral hygiene as a risk factor for infective endocarditis-related bacteremia. J Am Dent Assoc. 2009 Oct;140(10):1238-44. doi: 10.14219/jada.archive.2009.0046.

    PMID: 19797553DERIVED

MeSH Terms

Conditions

BacteremiaEndocarditis

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Peter B. Lockhart,, DDS

    Carolinas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2007

First Posted

March 30, 2007

Study Start

January 1, 2003

Primary Completion

November 1, 2005

Study Completion

June 1, 2006

Last Updated

April 25, 2022

Record last verified: 2009-12

Locations

US(1)