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The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178203
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Azad University of Medical Sciences
  Purpose
Aim: eliminating or reducing pain following endodontic treatment is of great importance. The aim of this study is to compare the effects of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis. Sample size: one hundred patients considering the inclusion and exclusion criteria were selected. Intervention and outcome: The effect of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis was evaluated.

Condition Intervention Phase
Pulpitis Pain Management Drug: Placebo Drug: Tramadol Drug: Novafen Drug: Naproxen Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Further study details as provided by Azad University of Medical Sciences:

Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Placebo
    Placebo
    Drug: Tramadol
    Tab, 100mg in 6, 12 and 24 hours after root canal treatment
    Drug: Novafen
    325 mg in 6, 12 and 24 hours after root canal treatment
    Drug: Naproxen
    Tab, 500 mg in 6, 12, and 24 hours after root canal treatment
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. The subjects were 20-60 years of age with no systemic diseases and females were not pregnant;
  2. No history of taking any analgesics or other drugs prior to presenting for treatment;
  3. Patients had moderate to severe pain associated with irreversible pulpitis in single-rooted premolars or anterior teeth.

Exclusion Criteria:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Peyman Mehrvarzfar, Department of Endodontics, Dental School of Tehran Azad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01178203     History of Changes
Other Study ID Numbers: IAU-1083
First Submitted: August 9, 2010
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
Last Verified: July 2010

Keywords provided by Azad University of Medical Sciences:
Endodontics
pain
visual analogue scale
NSAIDs

Additional relevant MeSH terms:
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Tramadol
Naproxen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action