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

Bleeding Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405613
• Other study ID #: HSF-201090
• Status: Completed
• Phase: Phase 2
• Start date: May 2003
• Est. completion date: December 2005

Study information

• Verified date: November 2006
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy

• Require a simple tooth extraction

Exclusion Criteria:

• Use of previous aspirin or NSAID

Related Conditions & MeSH terms

• Bleeding Complication
• Hemorrhage
• Postoperative Hemorrhage

Intervention

Drug:
• Aspirin

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral bleeding time
Secondary	Report of bleeding at phone follow-up at 3-7 (first follow-up) and 40-55 hours (second follow-up)