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

Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery: A Prospective, Double-Blind Study

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

Study Overview

• Status: Unknown
• Conditions: Pain; Edema; Trismus
• Intervention / Treatment: Drug: Etodalac, Etoricoxib and Dexamethasone

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: A

Drug: Etodalac, Etoricoxib and Dexamethasone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 week

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Study Chair: benjamin Shlomi, DMD, MAXILLOFACIAL SURGERY - TASMC

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: October 29, 2008
• First Submitted That Met QC Criteria: November 16, 2008
• First Posted (Estimate): November 19, 2008

Study Record Updates

• Last Update Posted (Estimate): November 19, 2008
• Last Update Submitted That Met QC Criteria: November 16, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: pain; Edema; trismus
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Spasm; Trismus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Cyclooxygenase 2 Inhibitors; Dexamethasone; Etoricoxib
• Other Study ID Numbers: TASMC-08-BS-062-CTIL