Effect of high-frequency bio-oxidative ozone therapy for masticatory muscle pain: a double-blind randomised clinical trial.

To evaluate the effect of bio-oxidative ozone application at the points of greatest pain in patients with chronic masticatory muscle pain. A total number of 40 (40 women, with a mean age of 31·7) were selected after the diagnosis of myofacial pain dysfunction syndrome according to the Research Diagnostic Criteria for temporomandibular disorder (RDC/TMD). The patients were randomly divided into two groups: patients received the ozone therapy at the point of greatest pain, ozone group (OG; n = 20); patients received the sham ozone therapy at the point of greatest pain, placebo group (PG; n = 20). Ozone and placebo were applied three times per week, for a total of six sessions. Mandibular movements were examined, masticator muscles tenderness were assessed and pressure pain threshold (PPT) values were obtained. Subjective pain levels were evaluated using visual analogue sale (VAS). These assessments were performed at baseline, 1 month and 3 months. Ozono therapy decreased pain intensity and increased PPT values significantly from baseline to 1 month and 3 months in OG compared with PG. PPTs of the temporal (OG = 24·85 ± 6·65, PG = 20·65 ± 5·43, P = 0.035) and masseter (OG = 19·03 ± 6·42, PG = 14·23 ± 2·95, P = 0.007) muscles at 3 months of control (T2) were significantly higher in the OG group. PPT value of the lateral pole was also significantly higher at T2 in the OG group (OG = 21·25 ± 8·43, PG = 15·35 ± 4·18, P = 0.012). Mandibular movements did not show significant differences between treatment groups except right lateral excursion values at T2 (OG = 8·90 ± 1·77, PG = 6·85 ± 2·41, P = 0.003); however, OG demonstrated significantly better results over time. Overall improvements in VAS scores from baseline to 3 months were OG 67·7%; PG 48·4%. Although ozone therapy can be accepted as an alternative treatment modality in the management of masticatory muscle pain, sham ozone therapy (placebo) showed significant improvements in the tested parameters.