A novel universal device“LINGUAL RING Ri.P.A.Ra” for TMDs and cranio-cervico-mandibular pains: preliminary results of a randomized control clinical trial

摘要

OBJECTIVE: The aim of this study was to evaluate functionality and clinical application of a novel immediate device in the treatment of temporomandibular disorders (TMDs). To address the research purpose, authors developed and implemented a randomized control clinical trial. PATIENTS AND METHODS: Eighty patients were enrolled in this study and were randomly divided into two subgroups based on the treatment applied: patient group (PG) and control group (CG). The CG was not subjected to any kind of treatment, even placebo, in order to be able to assess the spontaneous development of the pathology over time. The PG was treated applying the novel device for a maximum of three months. The following parameters were evaluated at baseline (T0) and at the end of therapy (T1): presence/absence of articular noises, painful symptomatology (articular pains, muscle pains, headache, cervicalgia), parafunctional habits and duration of symptoms. The x2-index of association was performed, with a p-value < 0.05 considered as statistically significant. RESULTS: No patient in the PG worsened its symptomatology. Thirteen patients (33%) declared themselves cured from their symptoms and were included in a monitoring protocol. Twenty-seven patients (67%) improved their symptoms and were treated with other conservative conventional methods to complete the therapeutic cycle. Therefore, 100% of PG obtained benefits from the application of the new therapeutic approach. In contrast, among patients of CG, eighteen subjects (45%) worsened their symptoms, while eighteen (45%) were defined as stationaries compared to T0 and only four (10%) were defined as improved. CONCLUSIONS: The device presented the following advantages: immediacy of use, reduction of waiting times for its application, good tolerability and comfort and specificity in the execution of tongue rehabilitation exercises.