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

Primary Purpose

Bleeding Complication

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding Complication focused on measuring Aspirin, Bleeding, Clinical Trial, Dental Extraction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy
  • Require a simple tooth extraction

Exclusion Criteria:

  • Use of previous aspirin or NSAID

Sites / Locations

  • Carolinas Medical Center

Outcomes

Primary Outcome Measures

Oral bleeding time

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2006
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00405613
Brief Title
Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population
Official Title
Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Complication
Keywords
Aspirin, Bleeding, Clinical Trial, Dental Extraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aspirin
Primary Outcome Measure Information:
Title
Oral bleeding time
Secondary Outcome Measure Information:
Title
Report of bleeding at phone follow-up at 3-7 (first follow-up) and 40-55 hours (second follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Require a simple tooth extraction Exclusion Criteria: Use of previous aspirin or NSAID
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael T Brennan, DDS,MHS
Organizational Affiliation
Carolinas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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