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

Charles Bertolami, T. Gay, G. T. Clark, J. Rendell, V. Shetty, C. Liu, D. A. Swann

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)232-242
Number of pages11
JournalJournal of Oral and Maxillofacial Surgery
Volume51
Issue number3
StatePublished - 1993

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Temporomandibular Joint Disorders
Controlled Clinical Trials
Hyaluronic Acid
Placebos
Visual Analog Scale
Joints
Osteoarthritis
Noise
Research Design
Therapeutics
Molecular Weight
Injections

ASJC Scopus subject areas

  • Dentistry(all)
  • Surgery

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Use of sodium hyaluronate in treating temporomandibular joint disorders : A randomized, double-blind, placebo-controlled clinical trial. / Bertolami, Charles; Gay, T.; Clark, G. T.; Rendell, J.; Shetty, V.; Liu, C.; Swann, D. A.

In: Journal of Oral and Maxillofacial Surgery, Vol. 51, No. 3, 1993, p. 232-242.

Research output: Contribution to journalArticle

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