A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for TMJ

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Collaborators:
University of California, Los Angeles
Oregon Health and Science University
University of Minnesota - Clinical and Translational Science Institute
University of Cincinnati
University of Pennsylvania
Information provided by (Responsible Party):
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
ClinicalTrials.gov Identifier:
NCT01524913
First received: January 29, 2012
Last updated: June 22, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function.

The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.


Condition Intervention Phase
Temporomandibular Joint Dysfunction
Pain
Arthrocentesis
Drug: Hyaluronic acid
Drug: Corticosteroid
Drug: Lactated Ringers
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pain will be assessed preoperatively and again at 1 and 3 months using a visual analogue scale


Secondary Outcome Measures:
  • Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Range of motion will be assessed preoperatively and again at 1 and 3 months using a millimeter ruler for maximum incisal opening and a jaw function limitation scale for other functional activities


Estimated Enrollment: 330
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyaluronic acid Drug: Hyaluronic acid
1 cc hyalgan to be injected into superior joint space
Active Comparator: Corticosteroid Drug: Corticosteroid
1cc celestone (6 mg/cc) will be injected into the joint space
Placebo Comparator: Saline Drug: Lactated Ringers
1 cc lactated ringers solution will be injected into the joint space

Detailed Description:

This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age greater than 18 years
  • arthralgia of one or both temporomandibular joints
  • Wilkes II to IV internal derangement of the symptomatic joint OR
  • limited opening of <35 mm

Exclusion Criteria:

  • myofascial pain as the primary source of pain

    • cervical pain as the primary source of pain
  • systemic arthropathy
  • fibromyalgia
  • use of NSAIDS within 48 hours
  • allergy to study medications
  • edentulous subjects
  • pregnancy or breast feeding
  • current physical therapy, muscle relaxants or antiseizure medications
  • current use of a splint issued within last 12 weeks
  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: NCT01524913

Contacts
Contact: Gary Bouloux, MD, DDS 404 778 4555 gfboulo@emory.edu

Locations
United States, California
University California Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Tara Agahloo, MD, DDS         
Principal Investigator: Tara Aghaloo, MD, DDS         
Sub-Investigator: Alan Felsenfeld, DDS         
Sub-Investigator: Nora Kahenasa, DDS         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Gary Bouloux, MD, DDS    404-778-4555    gfboulo@emory.edu   
United States, Ohio
University of Cinncinati Recruiting
Cinncinati, Ohio, United States, 45219
Contact: Deepak Krishnan, BDS         
Sub-Investigator: Robert Marciani, DMD         
United States, Oregon
Oregon Health Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Julie Smith, MD, DDS         
Sub-Investigator: Leon Assael, DMD         
Sub-Investigator: Robert Myall, BDS, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joli Choi, MD, DDS         
Sub-Investigator: Helen Giannakopoulos, MD, DDS         
Sponsors and Collaborators
Emory University
University of California, Los Angeles
Oregon Health and Science University
University of Minnesota - Clinical and Translational Science Institute
University of Cincinnati
University of Pennsylvania
Investigators
Principal Investigator: Gary F Bouloux, MD, DDS Emory University
  More Information

No publications provided

Responsible Party: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, National PI, Emory University
ClinicalTrials.gov Identifier: NCT01524913     History of Changes
Other Study ID Numbers: IRB00018682, Arthrocentesis
Study First Received: January 29, 2012
Last Updated: June 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014