Efficacy and safety of sodium hyaluronate in the treatment of Wilkes stage II disease.

ABSTRACT

PURPOSE: To show whether an intra-articular (IA) infiltration of 1 mL sodium hyaluronate (SH) into the temporomandibular joint (TMJ) would significantly reduce pain and improve joint function in Wilkes stage II disease, compared with the oral administration of a combination of methocarbamol and paracetamol. PATIENTS AND METHODS: Forty-one patients with Wilkes stage II disease were selected and randomly assigned to 2 groups. The experimental group received 1 IA infiltration of SH with assessments at days 14, 28, 56, and 84. The control group was given 2 tablets of a combination of methocarbamol 380 mg and paracetamol 300 mg every 6 hours for 4 weeks, with assessments at days 14 and 28. RESULTS: Forty-one patients were randomized into the study (SH 20 patients, control drug 21 patients). A statistically significant difference (P < . 05) was detected in favor of the SH group from day 56 onward for TMJ pain at rest, from day 14 onward for pain on jaw opening, and at days 28 and 56 for pain on mastication. The TMJ function was statistically significantly (P < .05) better in the test group at all follow-up visits. The global evaluation of efficacy by both, the patients and investigators, was better for the test group. No adverse reactions were detected with SH. CONCLUSIONS: An IA infiltration of SH showed better efficacy in reducing pain and improving joint function in Wilkes stage II disease, compared with the oral administration of methocarbamol-paracetamol tablets.