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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00793052
First received: October 29, 2008
Last updated: November 16, 2008
Last verified: November 2008
  Purpose

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


Condition Intervention
Trismus
Edema
Pain
Drug: Etodalac, Etoricoxib and Dexamethasone

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery: A Prospective, Double-Blind Study

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793052

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Study Chair: benjamin Shlomi, DMD MAXILLOFACIAL SURGERY - TASMC
  More Information

No publications provided

Responsible Party: Oral and maxillofacial surgery unit, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00793052     History of Changes
Other Study ID Numbers: TASMC-08-BS-062-CTIL
Study First Received: October 29, 2008
Last Updated: November 16, 2008
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Tel-Aviv Sourasky Medical Center:
trismus
Edema
pain

Additional relevant MeSH terms:
Trismus
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
Etoricoxib
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014