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

NCT ID: NCT00405613

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2005-12-31

Brief Summary

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

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.

Conditions

Bleeding Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Aspirin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy
• Require a simple tooth extraction

Exclusion Criteria

• Use of previous aspirin or NSAID

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael T Brennan, DDS,MHS

Role: PRINCIPAL_INVESTIGATOR

Carolinas Medical Center

Locations

Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

HSF-201090

Identifier Type: -

Identifier Source: org_study_id