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

Overview[ - collapse ][ - ]

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.
ConditionTemporomandibular Joint Dysfunction
Pain
Arthrocentesis
InterventionDrug: Hyaluronic acid
Drug: Corticosteroid
Drug: Lactated Ringers
PhasePhase 4
SponsorEmory University
Responsible PartyEmory University
ClinicalTrials.gov IdentifierNCT01524913
First ReceivedJanuary 29, 2012
Last UpdatedNovember 19, 2013
Last verifiedNovember 2013

Tracking Information[ + expand ][ + ]

First Received DateJanuary 29, 2012
Last Updated DateNovember 19, 2013
Start DateJanuary 2012
Estimated Primary Completion DateDecember 2014
Current Primary Outcome MeasuresPain [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
Current Secondary Outcome MeasuresFunction [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

Descriptive Information[ + expand ][ + ]

Brief TitleA Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for TMJ
Official TitleA Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction
Brief Summary
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.
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.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition
  • Temporomandibular Joint Dysfunction
  • Pain
  • Arthrocentesis
InterventionDrug: Hyaluronic acid
1 cc hyalgan to be injected into superior joint space
Drug: Corticosteroid
1cc celestone (6 mg/cc) will be injected into the joint space
Drug: Lactated Ringers
1 cc lactated ringers solution will be injected into the joint space
Study Arm (s)
  • Experimental: Hyaluronic acid
  • Active Comparator: Corticosteroid
  • Placebo Comparator: Saline

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment330
Estimated Completion DateDecember 2014
Estimated Primary Completion DateDecember 2014
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Gary Bouloux, MD, DDS
404 778 4555
gfboulo@emory.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01524913
Other Study ID NumbersIRB00018682
Has Data Monitoring CommitteeYes
Information Provided ByEmory University
Study SponsorEmory University
CollaboratorsUniversity 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
Verification DateNovember 2013

Locations[ + expand ][ + ]

University California Los Angeles
Los Angeles, California, United States, 90024
Contact: Tara Agahloo, MD, DDS
Principal Investigator: Tara Aghaloo, MD, DDS
Recruiting
Emory University
Atlanta, Georgia, United States, 30322
Contact: Gary Bouloux, MD, DDS | 404-778-4555 | gfboulo@emory.edu
Sub-Investigator: Martin Steed, DDS
Recruiting
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Pamela Hughes, MD, DDS
Sub-Investigator: Deepak Kademani, MD, DDS
Recruiting
University of Cinncinati
Cinncinati, Ohio, United States, 45219
Contact: Deepak Krishnan, BDS
Sub-Investigator: Robert Marciani, DMD
Not yet recruiting
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Contact: Julie Smith, MD, DDS
Sub-Investigator: Leon Assael, DMD
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Joli Choi, MD, DDS
Sub-Investigator: Helen Giannakopoulos, MD, DDS
Recruiting