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Table 17 Characteristics of the study of Magnusson et al [9]

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
Magnusson et al [9] Investigator-blinded randomized controlled trial To compare the therapeutic efficacy of two different intraoral devices in TMD patients. Patients referred for suspected TMDs to the Department of Stomatognathic Physiology, the Institute for Postgraduate Dental Education, Jönköping (Sweden) 1. TMD symptoms ≥ 6 months 1. Ongoing TMD therapy 28 (average age: 31.5 years; range: 16–70 years) NTI-tss device (n = 14) vs. Michigan-type stabilization splint (SS) (n = 14) worn at night
     2. Age: ≥ 16 years 2. Therapy with any kind of interocclusal appliance during the past year   
     3. ≥ 12 teeth both in the upper and lower jaw 3. TMD symptoms and signs justifiying another initial therapy than an interocclusal appliance   
     4. Moderate or severe clinical signs according to Helkimo's Clinical Dysfunction Index 4. Anterior teeth with periodontitis or fixed partial dentures   
     5. Pronounced subjective symptoms according to Helkimo's Anamnestic Index 5. Pronounced pre- or postnormal occlusion   
     6. Frequent tension-type headache 6. Deep bite   
      7. Psychic disorder   
      8. Language difficulties   
Study Study Duration Outcome parameters Results Authors' conclusions
Magnusson et al [9] 6 months - Mandibular mobility Within-treatment-group pre-post improvement 1. "The almost 100% treatment success that have been claimed after NTI treatment could not be confirmed in this study."
   - Deviation/deflectio 6-month follow-up of the NTI-group (n = 10): 2. "The statement of a gain in chair-side time with the NTI device can be questioned. The use of NTI devices, however, eliminates one clinical visit, as well as the laboratory costs."
   - n on jaw - significant improvement (n = 6) 3. "It can not be ruled out that long time use of NTI splints can be detrimental for the occlusion."
   - opening - some improvement (n = 1) "All of the studied variables were in favour for the stabilization splint, compared to the NTI device."
     - no change (n = 2)   
   - TMJ sounds - impairment (n = 1)   
   - Pain on mandibular movement - impaired occlusion (n = 1)   
   - Muscle/TMJ pain upon palpation - decreased use of analgetics (n = 2)   
   - Number of occluding teeth - increased use of analgetics (n = 2)   
   - Time for impression-taking, interocclusal recording and adjustment of stabilization splint - 6-point behavior scale: 3.4 → 2.1   
   - Time for fitting and adjustment of the NTI-tss device - 11-point numerical scale: 5.9 → 3.8   
   - Adherence to the allocated splint 6-month follow-up of the SS-group (n = 14):   
   - Use of analgetics - significant improvement (n = 12)   
   - Symptom intensity (6-point behavior scale, 11-point numerical scale) - some improvement (n = 2)   
     - decreased use of analgetics (n = 10)   
     - 6-point behavior scale: 3.4 → 1.9   
     - 11-point numerical scale: 5.9 → 3.3   
     Between-groups post-treatment differences   
     - 3-month follow-up: 4 patients with NTI-tss device changed to SS due to impairment or no improvement of their symptoms, while none of the SS users changed the group.   
     - For all variables, improvement was larger in the SS-group than the NTI-group   
     - SS-appliances were judged to be more comfortable than the NTI-tss device   
     Mean production time   
     - NTI-tss device: 27 minutes   
     - SS: 17 minutes