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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
  Purpose

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


Condition Intervention Phase
Bleeding Complication
 Drug: Aspirin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by Carolinas Healthcare System:

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)

Estimated Enrollment: 36
Study Start Date: May 2003
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Require a simple tooth extraction

Exclusion Criteria:

  • Use of previous aspirin or NSAID
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00405613     History of Changes
Other Study ID Numbers: HSF-201090
Study First Received: November 28, 2006
Last Updated: November 28, 2006
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Anti-Inflammatory Agents
 Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013