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

This study has been completed.
Information provided by:
Carolinas Healthcare System Identifier:
First received: November 28, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
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:

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.

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

Inclusion Criteria:

  • Healthy
  • Require a simple tooth extraction

Exclusion Criteria:

  • Use of previous aspirin or NSAID
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00405613

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

No publications provided 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:
Clinical Trial
Dental Extraction

Additional relevant MeSH terms:
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses processed this record on February 04, 2016