Study | Type of study | Aim of the study | Patient recruitment | Inclusion criteria | Exclusion criteria | n | Therapeutic comparison |
---|---|---|---|---|---|---|---|
Investigator-blinded randomized controlled trial | To compare the therapeutic efficacy of two different intraoral devices in TMD patients. | TMD patients referred to or applying for therapy at the Department of Prosthetic Dentistry and Stomatognathic Physiology, Faculty of Dentistry, University of Oslo (Norway) | Adults who had experienced TMD symptoms for at least 6 months, e.g., | 1. Partial protheses with distal extensions | 38 (average age: 37 years; range: 17–62 years) | NTI-tss device (n = 18) vs. Michigan-type stabilization splint (SS) (n = 20) | |
- impaired range of motion | 2. Additional TMD therapy during the trial | ||||||
- impaired TMJ function | 3. Recent facial or cervical trauma | worn at night | |||||
- muscle pain | |||||||
- TMJ pain | |||||||
- pain on mandibular movement | |||||||
Plus (both groups): | |||||||
1. counseling | |||||||
2. muscle relaxation exercises | |||||||
Study | Study duration | Outcome parameters | Results | Authors' conclusions | |||
3 months | - Self-reported headache and TMD-related pain on a 100 mm VAS | Within-treatment-group pre-post differences | 1. The therapeutic efficacy between an NTI-tss device and a Michigan splint did not differ over an observation period of three months. | ||||
- Maximum unassisted jaw opening | - Average jaw opening increased in both groups | ||||||
- Tenderness on palpation of masticatory muscles, neck and shoulder muscles and TMJs on a 100 mm VAS | - VAS scores for TMD-related pain and self reported headache decreased significantly between baseline and 3-months examination in both groups | ||||||
- Reduction of jaw muscle (but not neck and shoulder muscles) tenderness upon palpation in both groups | |||||||
- No changes of TMJ tenderness upon palpation | |||||||
Between-groups post-treatment differences | |||||||
- Comfort of splint use on a 100 mm VAS | - No differences between NTI-tss and SS groups at the 3-months examination | ||||||
- In both groups, the comfort of splint use appeared to be similar at each control examination with a (statistically not significant) trend of higher comfort for the NTI-device |