[Glucosamine hydrochloride combined with hyaluronate for temporomandibular joint osteoarthritis: a primary report of randomized controlled trial].

OBJECTIVE

To investigate effectiveness and safety of combined treatment with glucosamine hydrochloride orally and hyaluronate intraarticularly in patients with temporomandibular joint osteoarthritis.

METHODS

Twenty eight participants who were diagnosed as temporomandibular joint osteoarthritis were randomly allocated to intervention and control groups (n = 14). The former received oral glucosamine hydrochloride (each day 1.44 g) and the latter placebo for four weeks. Both groups received intraarticular injection of hyaluronate for upper and inferior compartment, once a week for four weeks. Maximal mouth opening, pain on opening, deviation at the end of opening were measured at baseline and each week of follow up, quality of life was measured by using the instrument of oral health impact profile-14 (OHIP-14) at baseline and the fourth week. Intention-to-treat analysis was adopted for data analysis.

RESULTS

All participants except two in control group adhered to the follow-up. Parameters on baseline were balanced between the two groups. Maximal mouth opening was significantly increased in intervention group compared with control group (P = 0.03) and decrease was found for pain on opening (P = 0.02). No statistical difference was detected between the two groups on deviation (P = 0.67). The intervention group didn't show advantages compared with placebo on quality of life assessed by OHIP-14 (P = 0.77). No serious adverse drug events were detected in both groups.

CONCLUSIONS

The glucosamine hydrochloride plus double joint cavity injection of hyaluronate is safe and may reduce pain scores and improve opening in patients with temporomandibular joint osteoarthritis.