Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population

April 19, 2022 updated by: Wake Forest University Health Sciences

The purpose of this study is to determine if aspirin is associated with bleeding complications following a single tooth extraction

Study Overview

Status

Completed

Conditions

Bleeding Complication

Intervention / Treatment

Drug: Aspirin

Detailed Description

Aspirin is a common chronically administered preventive treatment for cardiovascular disease, but is often discontinued prior to invasive dental procedures because of concern of bleeding complications. As the goal of aspirin is often to prevent MI and stroke, the risk of these CVD outcomes with discontinuation of aspirin must be weighed against the perceived adverse event of bleeding during or following an invasive dental procedure with continuation of aspirin. The current study is a randomized controlled trial evaluating bleeding complications of aspirin vs. placebo in healthy patients schedule for a single tooth extraction.

Study Type

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Charlotte, North Carolina, United States, 28232
    - Carolinas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy
Require a simple tooth extraction

Exclusion Criteria:

Use of previous aspirin or NSAID

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Oral bleeding time

Secondary Outcome Measures

Outcome Measure
Report of bleeding at phone follow-up at 3-7 (first follow-up) and 40-55 hours (second follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

Principal Investigator: Michael T Brennan, DDS,MHS, Carolinas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 28, 2006

First Posted (Estimate)

November 30, 2006

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

HSF-201090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.