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Table 15 Characteristics of the study of Kavaklı [21]

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
Kavaklı [21] Randomized controlled trial To compare the therapeutic efficacy of two different intraoral devices on the EMG activity of bruxers during sleep. Self-presentation at the Hacettepe University Health Science Institute, Ankara (Turkey) 1. Self-reported tooth clenching and tooth grinding for at least 6 month 1. More than two missing molars 20 (average age: 31 years; range: 14–52 years) NTI-tss device (n = 11) vs. Michigan- type stabilization splint (SS) (n = 9) worn at night
     2. Grinding sounds during sleep for at least 3 nights per week as confirmed by bed-partner 2. Removable prosthetic restoration   
     3. Jaw muscle discomfort 3. Gross malocclusion   
     4. Abnormal tooth wear 4. Constant use of sleep medication   
     5. Masseter hypertrophy 5. Abuse of alcohol and/or drugs   
     6. Diagnosis of sleep bruxism in a sleep laboratory 6. Neurological or psychological diseases   
      7. Sleeping disorders   
      8. Internal TMJ derangements as diagnosed with an MRI   
Study Study duration Outcome parameters Results Authors' conclusions
Kavaklı [21] 4 months (A) Sleep variables: Within-treatment-group pre- post differences 1. Both splint designs do not stop sleep bruxism activity as shown by polysomnographic evaluation.
   - sleep quality     
   - total sleep time NTI-tss device: 2. The SS does not reduce the frequency, duration or intensity of the sleep bruxism.
   - sleep efficiency - no changes of other sleep parameters 3. The NTI-tss device reduces the intensity of bruxism.
   - sleep latency - no changes of respiratory parameters 4. Due to its positive effect on sleep bruxism and its easy adapatability, the NTI-tss device is recommended if regular check-ups by a dentist are possible.
   - REM latency - no changes in occlusion   
   - percentages of stage duration - reduced intensity of masseter and temporalis muscles contraction activities compared to baseline   
   - number of awakenings during sleep     
   - number of movements during sleep     
     Stabilization splint:   
   (B) Respiratory variables: - sleep stage 2 was shorter as compared to baseline   
   - apnea     
   - hypoapnea - no changes of other sleep parameters   
   (C) Bruxism-related variables as derived from masseter and temporal muscle activity: - no changes of respiratory parameters   
   - total bruxism duration - no changes of sleep bruxism activity   
   - number of bruxism episodes/night     
   - number of bruxism episodes/h Between-groups post- treatment differences
No changes
   - number of bruxism burst/episode     
   - number of bruxism burst/h     
   - amplitude of bruxism episodes