A novel vibratory stimulation-based occlusal splint for alleviation of TMD painful symptoms: a pilot study E. S. HARA*, A. L. WITZEL † , C. E. P. DE LUCA † , R. Y. BALLESTER ‡ , T. KUBOKI* & M. C. BOLZAN § *Oral Rehabilitation and Regenerative Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Japan, † Department of Clinical Stomatology, School of Dentistry, University of São Paulo, § Department of Dental Materials, School of Dentistry, University of S~ao Paulo and ¶ Fundac ß~ao para o Desenvolvimento Cientıfico e Tecnologico da Odontologia attached to the School of Dentistry, University of S~ao Paulo, Brazil SUMMARY This pilot study introduces a novel vibratory stimulation-based occlusal splint (VibOS) for management of pain related to temporomandibular disorders (TMD). The study sample consisted of 10 patients (mean age: 40 5 13 7 years, male/female: 3/7) who were using stabilisation splints for more than 2 months prior to the study onset and still complained of pain. Patients utilised the active and inactive VibOS during 15 days in a crossover designed clinical trial. The analysed variables were self- reported VAS pain levels and number of painful sites to palpation (PSP). Statistical analysis was performed with repeated measures ANOVA. At baseline, mean VAS pain levels for group I and II were 45 6 21 0 mm and 37 4 16 3 mm, respectively. Comparison between these baseline values showed no statistical difference (P > 0 05, unpaired t-test). In group I, the inactive VibOS caused a slight increase in VAS pain levels, whereas the active VibOS promoted a significant decrease in VAS pain levels and PSP (P < 0 01). In group II, which received the active VibOS first, a significant decrease in VAS levels (P < 0 05) and in PSP (P < 0 01) was observed. No significant decrease in VAS pain levels or PSP (P > 0 05) was observed with the use of the inactive VibOS. In conclusion, this study demonstrated a good tendency of this novel VibOS in the alleviation of painful symptoms related to TMD after a 15-day management period compared to control VibOS. KEYWORDS: vibration, temporomandibular disorder, occlusal splint, biofeedback device, vibratory stimulation Accepted for publication 6 December 2012 Introduction Temporomandibular disorders (TMD) involve a large number of pathologies related to masticatory muscles and/or the temporomandibular joints (TMJs) and have been reported to cause significant psychological impairment and decrease in individuals’ perceived quality of life (1, 2). Traditional management approaches with acrylic occlusal splints, physical ther- apy and non-steroidal anti-inflammatory drugs (NSA- IDs) have been reported to be successful in approximately 75% of the cases (3). However, the reason why the remaining 25% of the cases become chronic is still unclear. Possible reasoning could be related to inaccurate diagnosis, ongoing causative fac- tors or ineffective/inappropriate treatment approaches (3). Cognitive and emotional disturbances such as stress, depression, anxiety and/or somatisation, as well as clenching or grinding habit have also been associ- ated with aggravation and/or perpetuation of TMD symptoms (4–8). Better symptom improvement is sometimes achieved with concomitant prescription of systemic drugs, for example, tricyclic antidepressants, © 2013 Blackwell Publishing Ltd doi: 10.1111/joor.12026 Journal of Oral Rehabilitation 2013 40; 179--184 Journal of Oral Rehabilitation