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

This study has been completed.

Sponsor:

Information provided by:

Carolinas Healthcare System

ClinicalTrials.gov Identifier:

NCT00405613

First received: November 28, 2006

Last updated: NA

Last verified: November 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 28, 2006

Last Updated Date

November 28, 2006

Start Date ^ICMJE

May 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Oral bleeding time

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Bleeding Complication

Intervention ^ICMJE

Drug: Aspirin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy
Require a simple tooth extraction

Exclusion Criteria:

Use of previous aspirin or NSAID

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00405613

Other Study ID Numbers ^ICMJE

HSF-201090

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Carolinas Healthcare System

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael T Brennan, DDS,MHS

Carolinas Medical Center

Information Provided By

Carolinas Healthcare System

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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