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Table 14 Characteristics of the study of Baad-Hansen et al [22]

From: The NTI-tss device for the therapy of bruxism, temporomandibular disorders, and headache – Where do we stand? A qualitative systematic review of the literature

Study Type of study Aim of the study Patient recruitment Inclusion criteria Exclusion criteria n Therapeutic comparison
Baad-Hansen et al [22] Investigator-blinded randomized controlled cross-over trial 1. To compare the therapeutic efficacy of two different intraoral devices on the EMG activity of bruxers during sleep. Self-presentation of patients at the School of Dentistry, University of Aarhus (Denmark) 1. Self-reported tooth-grinding during sleep, confirmed by bed-partner. Use of any other medication than mild analgesics 10 (average age: not reported; range: 23–39 years) NTI-tss device (n = 10) vs. flat occlusal stabilization splint (OS) (n = 10) worn at night
     2. Reports of muscle soreness on awakening.    
     3. Signs of tooth wear.    
   2. To evaluate if changes in EMG activity are associated with short-term changes in TMD-related pain.   4. TMD diagnosis by a blinded investigator according to the RDC/TMD [111].    
Study Study duration Outcome parameters Results Authors' conclusions
Baad-Hansen et al [22] 7–8 weeks 1. "A strong and lasting inhibition of EMG activity in masseter muscles during sleep was caused by wearing the NTI splint but not the OS. However, this was not directly related to the short-term clinical outcome measures." Within-treatment-group pre-post differences "A strong and lasting inhibition of EMG activity in masseter muscles during sleep was caused by wearing the NTI splint but not the OS. However, this was not directly related to the short-term clinical outcome measures
    NTI-tss group:   
    - Significant decreases at all levels of EMG threshold during the use of the NTI-tss device when compared with baseline.   
    OS group:   
    - No differences between the baseline EMG values for any of the EMG measures.   
    Between-groups post-treatment differences   
    EMG outcomes:   
    In contrast to the OS, the NTI-tss device was associated with significant decreases when compared with EMG baseline values.   
    Clinical outcomes:   
    - No differences between the two therapies   
    - No significant correlations between EMG data and clinical variables.