Back to resultsAspirin 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
About this trial
This is an interventional treatment trial for Bleeding Complication focused on measuring Aspirin, Bleeding, Clinical Trial, Dental Extraction
Eligibility Criteria
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
NCT ID
NCT00405613
First Posted
November 28, 2006
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
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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