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

Primary Purpose

Pulpitis, Pain Management

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
Tramadol
Novafen
Naproxen
Sponsored by
Azad University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis focused on measuring Endodontics, pain, visual analogue scale, NSAIDs

Eligibility Criteria

20 Years - 60 Years (Adult)All Sexes

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:

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 9, 2010
    Last Updated
    August 9, 2010
    Sponsor
    Azad University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01178203
    Brief Title
    The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Azad University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis, Pain Management
    Keywords
    Endodontics, pain, visual analogue scale, NSAIDs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol
    Intervention Description
    Tab, 100mg in 6, 12 and 24 hours after root canal treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Novafen
    Intervention Description
    325 mg in 6, 12 and 24 hours after root canal treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Naproxen
    Intervention Description
    Tab, 500 mg in 6, 12, and 24 hours after root canal treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Eligibility Criteria
    Inclusion Criteria: The subjects were 20-60 years of age with no systemic diseases and females were not pregnant; No history of taking any analgesics or other drugs prior to presenting for treatment; Patients had moderate to severe pain associated with irreversible pulpitis in single-rooted premolars or anterior teeth. Exclusion Criteria:

    12. IPD Sharing Statement

    Learn more about this trial

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

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