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. |
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Condition | Temporomandibular Joint Dysfunction Pain Arthrocentesis |
Intervention | Drug: Hyaluronic acid Drug: Corticosteroid Drug: Lactated Ringers |
Phase | Phase 4 |
Sponsor | Emory University |
Responsible Party | Emory University |
ClinicalTrials.gov Identifier | NCT01524913 |
First Received | January 29, 2012 |
Last Updated | November 19, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 29, 2012 |
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Last Updated Date | November 19, 2013 |
Start Date | January 2012 |
Estimated Primary Completion Date | December 2014 |
Current 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 |
Current 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 |
Descriptive Information[ + expand ][ + ]
Brief Title | A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for TMJ |
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Official Title | A 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 Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition |
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Intervention | Drug: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 330 |
Estimated Completion Date | December 2014 |
Estimated Primary Completion Date | December 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Gary Bouloux, MD, DDS 404 778 4555 gfboulo@emory.edu |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01524913 |
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Other Study ID Numbers | IRB00018682 |
Has Data Monitoring Committee | Yes |
Information Provided By | Emory University |
Study Sponsor | Emory University |
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 |
Investigators | Principal Investigator: Gary F Bouloux, MD, DDS Emory University |
Verification Date | November 2013 |
Locations[ + expand ][ + ]
University California Los Angeles | Los Angeles, California, United States, 90024 Contact: Tara Agahloo, MD, DDSPrincipal Investigator: Tara Aghaloo, MD, DDS Recruiting |
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Emory University | Atlanta, Georgia, United States, 30322 Contact: Gary Bouloux, MD, DDS | 404-778-4555 | gfboulo@emory.eduSub-Investigator: Martin Steed, DDS Recruiting |
University of Minnesota | Minneapolis, Minnesota, United States, 55455 Contact: Pamela Hughes, MD, DDSSub-Investigator: Deepak Kademani, MD, DDS Recruiting |
University of Cinncinati | Cinncinati, Ohio, United States, 45219 Contact: Deepak Krishnan, BDSSub-Investigator: Robert Marciani, DMD Not yet recruiting |
Oregon Health Sciences University | Portland, Oregon, United States, 97239 Contact: Julie Smith, MD, DDSSub-Investigator: Leon Assael, DMD Recruiting |
University of Pennsylvania | Philadelphia, Pennsylvania, United States, 19104 Contact: Joli Choi, MD, DDSSub-Investigator: Helen Giannakopoulos, MD, DDS Recruiting |