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

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ClinicalTrials.gov Identifier: NCT00405613
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : November 30, 2006
Sponsor:
Information provided by:
Carolinas Healthcare System

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

Condition or disease Intervention/treatment Phase
Bleeding Complication Drug: Aspirin Phase 2

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 : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population
Study Start Date : May 2003
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Aspirin
U.S. FDA Resources




Primary Outcome Measures :
  1. Oral bleeding time

Secondary Outcome Measures :
  1. Report of bleeding at phone follow-up at 3-7 (first follow-up) and 40-55 hours (second follow-up)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Require a simple tooth extraction

Exclusion Criteria:

  • Use of previous aspirin or NSAID

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405613


Locations
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Michael T Brennan, DDS,MHS Carolinas Medical Center

ClinicalTrials.gov Identifier: NCT00405613     History of Changes
Other Study ID Numbers: HSF-201090
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: November 2006

Keywords provided by Carolinas Healthcare System:
Aspirin
Bleeding
Clinical Trial
Dental Extraction

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics