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Use of sodium hyaluronate in treating temporomandibular joint disorders: a randomized, double-blind, placebo-controlled clinical trial.

Abstract
This study assessed the efficacy of high-molecular-weight sodium hyaluronate as a treatment for certain intracapsular temporomandibular joint (TMJ) disorders. One hundred twenty-one patients were studied at three test sites using a randomized, double-blind, placebo-controlled experimental design. Patients were selected on the basis of 1) confirmed diagnosis of either degenerative joint disease (DJD), reducing displaced disc (DDR), or nonreducing displaced disc (DDN); 2) nonresponsiveness to nonsurgical therapies; and 3) severe dysfunction as established by the Helkimo indices (HI), visual analog scales (VASs), and physical measurements of joint movement and joint noise (arthrophonometry [APM]). Subjects received a unilateral upper joint space injection of either 1) 1% sodium hyaluronate in physiologic saline (MedChem Products, Woburn, MA) or 2) USP physiologic saline. Clinical evaluations were performed using HI, VAS, and APM at weekly intervals for the first month and then at monthly intervals up to 6 months postinjection. Statistical analyses for both categorical and continuous variables were performed for each diagnostic category at each examination interval. For DJD, no difference in outcome was seen between treatment groups. For DDN, significant between-group differences were seen through 1 month; however, beyond this time point, the number of DDN patients was insufficient to draw meaningful conclusions concerning efficacy. For DDR, statistically significant within-group and between-group improvement in all three measures (HI, VAS, APM) was seen for the hyaluronate group compared to the saline group throughout the 6-month test period. At the month-2 and month-3 examination intervals, twice as many patients treated with hyaluronate (90%) showed improvement compared to patients given placebo. Further, only 3% of patients with DDR who were treated with hyaluronate relapsed compared with 31% of patients with DDR given placebo.
AuthorsC N Bertolami, T Gay, G T Clark, J Rendell, V Shetty, C Liu, D A Swann
JournalJournal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons (J Oral Maxillofac Surg) Vol. 51 Issue 3 Pg. 232-42 (Mar 1993) ISSN: 0278-2391 [Print] United States
PMID8445463 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Placebos
  • Hyaluronic Acid
Topics
  • Adult
  • Cartilage, Articular (pathology, physiopathology)
  • Double-Blind Method
  • Facial Pain (drug therapy, physiopathology, psychology)
  • Female
  • Humans
  • Hyaluronic Acid (administration & dosage, adverse effects, therapeutic use)
  • Injections, Intra-Articular
  • Joint Dislocations (drug therapy, physiopathology)
  • Male
  • Movement
  • Osteoarthritis (drug therapy, physiopathology)
  • Patient Satisfaction
  • Placebos
  • Prospective Studies
  • Self Concept
  • Sound
  • Temporomandibular Joint Disorders (drug therapy, physiopathology, psychology)
  • Time Factors

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