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
About this trial
This is an interventional treatment trial for Trismus focused on measuring trismus, Edema, pain
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
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
NCT ID
NCT00793052
First Posted
October 29, 2008
Last Updated
November 16, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
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
Learn more about this trial
Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery
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