RESUMO
BACKGROUND: Temporomandibular disorders (TMD) are a collective term for pain and dysfunction of the masticatory muscles and the temporomandibular joints. The most common types of TMD are pain-related, which may impact the psychological behavior and quality of life. Currently, the most popular methods for the treatment of TMD patients are occlusal splint therapy, often in combination with physical- and/or pharmacotherapy. However, due to the complexity of etiology, the treatment of chronic TMD remains a challenge. Recently, CE-certified systems for non-invasive VNS (transcutaneous auricular vagus nerve stimulation, taVNS) have become available and show positive effects in the treatment of chronic pain conditions, like migraine or fibromyalgia, with which TMD shares similarities. Therefore, it is the main purpose of the study to evaluate the feasibility of daily taVNS against chronic TMD and to assess whether there is an improvement in pain severity, quality of life, and kinetic parameters. METHODS: This study is designed as a single-blinded, double-arm randomized controlled trial (RCT) in a 1:1 allocation ratio. Twenty adult patients with chronical TMD symptoms will be enrolled and randomized to stimulation or sham group. In the stimulation group, taVNS is performed on the left tragus (25 Hz, pulse width 250 µs, 28 s on/32 s off, 4 h/day). The sham group will receive no stimulation via a non-functional identical-looking electrode. Validated questionnaire data and clinical parameters will be collected at the beginning of the study and after 4 and 8 weeks. The compliance of a daily taVNS of patients with chronical TMD will be evaluated via a smartphone app recording daily stimulation time and average intensity. Additionally, the treatment impact on pain severity and quality of life will be assessed with different questionnaires, and the effect on the mandibular mobility and muscle activity will be analyzed. DISCUSSION: This is the first clinical trial to assess the feasibility of taVNS in patients with chronic TMD symptoms. If taVNS improves the symptoms of TMD, it will be a significant gain in quality of life for these chronic pain patients. The results of this pilot study will help to determine the feasibility of a large-scale RCT. TRIAL REGISTRATION: This study has been registered in the DRKS database (DRKS00029724).
RESUMO
OBJECTIVE: To investigate the effect of ceramic thickness and dental substrate (enamel vs. dentin/enamel) on the survival rate and failure load of non-retentive occlusal veneers. MATERIALS AND METHODS: Human maxillary molars (n = 60) were divided into five test-groups (n = 12). The groups (named DE-1.5, DE-1.0, DE-0.5, E-1.0, E-0.5) differed in their dental substrate (E = enamel, DE = dentin/enamel) and restoration thickness (standard: 1.5 mm, thin: 1.0 mm, ultrathin: 0.5 mm). All teeth were prepared for non-retentive monolithic lithium-disilicate occlusal veneers (IPS e.max Press, Ivoclar). Restorations were adhesively cemented (Syntac Classic/Variolink II, Ivoclar) and exposed to thermomechanical fatigue (1.2 million cycles, 1.6 Hz, 49 N/ 5-55°C). Single load to failure was performed using a universal testing-machine. A linear-regression model was applied, pairwise comparisons used the Student-Newman-Keuls method (p < 0.05). RESULTS: Three dentin-based occlusal veneers (one DE-1.0, two DE-0.5) revealed cracks after fatigue exposure, which corresponds to an overall-survival rate of 95%. Load to failure resulted in the following ranking: 2142 N(DE-0.5) > 2105 N(E-1.0) > 2075 N(E-0.5) > 1440 N(DE-1.5) > 1430 N(DE-1.0). Thin (E-1.0) and ultrathin enamel-based occlusal veneers (E-0.5) revealed high failure loads and surpassed the standard thickness dentin-based veneers (DE-1.5) significantly (p = 0.044, p = 0.022). CONCLUSION: All tested monolithic lithium disilicate occlusal veneers obtained failure loads above physiological chewing forces. Thin and ultrathin enamel-based occlusal veneers outperformed the standard thick dentin-based occlusal veneers. CLINICAL SIGNIFICANCE: Minimally invasive enamel-based occlusal veneer restorations with non-retentive preparation design may serve as a conservative treatment option.