Pilot randomised double-blind clinical trial of ozone therapy for temporomandibular joint arthralgia.

OBJECTIVE: To assess the effects of ozone therapy versus pure oxygen in patients with TMJ arthralgia, evaluating pain intensity and functional, somatosensory, and psychosocial outcomes. METHODS: This pilot randomised double-blind clinical trial included 13 women diagnosed with TMJ arthralgia, according to the Diagnostic Criteria for TMD (DC/TMD), that received three intra-articular treatment sessions at 72-hour intervals. Participants were treated with either 2 ml of an oxygen-ozone mixture (10 μg/ml; O3 group) or pure oxygen (O2 group). All study variables were assessed before each session and the last follow-up (one week after last session and one month after first session). RESULTS: Pain intensity decreased over time in both groups (p < .05). O3 group showed improvement in maximum pain-free opening and PPT values while O2 group improved in protrusion and pain catastrophizing (p < .05). No significant between-group differences were found in any variable at any assessment (p > .05). DISCUSSION: Although both interventions were associated with improvements over time, ozone therapy did not demonstrate superiority over pure oxygen in this pilot study. These results require confirmation in adequately powered randomised clinical trials.