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Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery

Primary Purpose

Trismus, Edema, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Etodalac, Etoricoxib and Dexamethasone
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trismus focused on measuring trismus, Edema, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who are refered for third molar extraction to our center
  • Must be able to swallow tablets

Exclusion Criteria:

  • Diabetes mellitus
  • Thyroid diseases
  • Cardiovascular diseases
  • renal diseases
  • hepatic diseases
  • respiratory system diseases
  • adrenal diseases
  • Allergy to Etodalac, Etoricoxib or Dexamethasone
  • Gastric ulcers
  • psychiatric diseases
  • Pregnant or breast feeding womans

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A

    Arm Description

    Outcomes

    Primary Outcome Measures

    PAIN- By VAS graded from 1-10 TRISMUS- By MAX mouth opening from the first incisors adages POST OPERATIVE SWELLing - By measurement the distance between the Right and LEFT ear's tragus

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2008
    Last Updated
    November 16, 2008
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00793052
    Brief Title
    Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery
    Official Title
    Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery: A Prospective, Double-Blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    December 2009 (Anticipated)
    Study Completion Date
    December 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Etodalac, Etoricoxib and Dexamethasone are effective for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trismus, Edema, Pain
    Keywords
    trismus, Edema, pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    N/A
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Etodalac, Etoricoxib and Dexamethasone
    Intervention Description
    Dexamethasone sodium phosphate 8 mg 1 hour before the extraction, 4 mg the day after the extraction and another 4 mg at second day to the extraction. Etoricoxib 120 mg 1 hour before the extraction, 120 mg the day after the extraction and another 120 mg at second day to the extraction. Etodalac 600 mg 1 hour before the extraction, 600 mg the day after the extraction and another 600 mg at second day to the extraction.
    Primary Outcome Measure Information:
    Title
    PAIN- By VAS graded from 1-10 TRISMUS- By MAX mouth opening from the first incisors adages POST OPERATIVE SWELLing - By measurement the distance between the Right and LEFT ear's tragus
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who are refered for third molar extraction to our center Must be able to swallow tablets Exclusion Criteria: Diabetes mellitus Thyroid diseases Cardiovascular diseases renal diseases hepatic diseases respiratory system diseases adrenal diseases Allergy to Etodalac, Etoricoxib or Dexamethasone Gastric ulcers psychiatric diseases Pregnant or breast feeding womans
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    benjamin Shlomi, DMD
    Organizational Affiliation
    MAXILLOFACIAL SURGERY - TASMC
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery

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