Background: Painful disorders of the temporomandibular joints are among the more common diseases in older people. One of the non-invasive measures available is drug therapy to reduce inflammation and pain. The effects and side effects of these medications are therefore of interest.
Aim: Adults who visited a dentist and needed treatment due to osteoarthritis-related pain in the temporomandibular joint area should be monitored regarding pain intensity and the impairments of oral-health-related quality of life in this context. Also, undesirable side effects of taking an analgesic and anti-inflammatory medication should be recorded.
Method: In a non-interventional observational study, 85 adult participants (18% men, age range 19–93 years) suffering from painful osteoarthritis in one or both temporomandibular joints were included by 29 established study centers in Germany. Before inclusion in the study, the patients were examined according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), and both pain intensity (numerical analog scale, graded chronic pain scale (GCPS) V2) and oral-health-related quality of life (OHRQoL, OHIP-5) were recorded (T1, N = 85). The inclusion criterion was planned treatment with oxaceprol for at least 90 days. The target parameters were re-evaluated after 28 days (T2, N = 73) and 90 days (T3, N = 60).
Results: The average pain intensity of the participants over the previous 30 days decreased from 5.5 (T1) to 3.9 (T2) and 2.5 (T3, analysis of variance (ANOVA) p = 0.001). The effect size of the reduction in pain was 0.58. The maximum pain-free jaw opening improved from an average of 33.0 mm incisal edge distance (T1) to 36.6 mm (T2) and 37.9 mm (T3, ANOVA p = 0.001). The effect size regarding the improvement of maximum pain-free jaw opening was weak. The OHRQoL improved from 6.3 (T1) to 5.6 (T2) and 4.2 OHIP points (T3, Friedman test p = 0.001). The effect size regarding OHRQoL was weak. The reported side effects were mild and transient.
Conclusion: The ingestion of oxaceprol was accompanied by a reduction in pain, improvement in pain-free maximum jaw opening, and improvement in OHRQoL. Only mild adverse drug reactions occurred.
Parole chiave: pharmaceutical intervention, non-interventional study, temporomandibular disorders (TMD), temporomandibular joint arthritis, multicenter study, chronic pain
