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 |