bruxism, myalgia, Other specified headache syndromes
Conditions
Interventions
This is a clinical study designed to assess the therapeutic effectiveness of a stabilizing occlusal splint printed in adults with muscular temporomandibular disorder (TMD). The study will be conducted
Sponsors
Universidade de São Paulo - Faculdade de Odontologia
Universidade de São Paulo - Faculdade de Odontologia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Both sexes; Over 18 years; with signs and symptoms of temporomandibular disorders (TMD) identified by the temporomandibular disorders diagnostic criterion questionnaire (CD/TMD) by a single calibrated evaluator; diagnosed with spreading myofascial pain; local myalgia; referred pain; disc displacement with reduction with painful symptoms; disc displacement without reduction; participants with arthralgia and joint noise (crepitus) must present additional MRI examination of the temporomandibular joint (TMJ) and/or computed tomography of the TMJ at the time of physical assessment
Exclusion criteria
Exclusion criteria: Patients with local osteoarthritis with open lesions such as erosion and subchondral sclerosis in the condyle, disc perforation and systemic osteoarthritis; users of bruxism-inducing medications such as serotonin reuptake inhibitors; presenting an accentuated curve of Spee >2mm with gross interference during disocclusion movements and in the maxillomandibular position; undergoing temporomandibular joint (TMJ) prosthesis surgery; in premature treatment; pregnant women; completely toothless; unimaxillary; unrehabilitated bimaxilla
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The assessment will be conducted through changes in the Visual Analog Scale/Numeric Rating Scale for "chewing pain in the last 30 days", comparing baseline with 12 weeks of intervention. Verification Method: It will be verified using the method of measuring pain intensity reported on the Visual Analog Scale/Numeric Rating Scale between baseline and after 12 weeks of intervention. Parameters Used: We will observe the difference in pain intensity scores between baseline and the end of the intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the operator's perceived difficulty during splint installation for both interventions and compare the difference in adaptation;Evaluate the difference in splint wear between baseline and after 12 weeks using mesh overlay and comparison of splint meshes at different time points;Determine the increase in functional mobility after 12 weeks of intervention compared to the baseline, using the method of specific functional mobility measurement for TMD;Evaluate the reduction in joint noises (clicking and crepitus) after 12 weeks of intervention compared to the baseline, using the method of auscultation during mandibular movement;Assess the cost-effectiveness of both types of splints by comparing the time required for adjustment and fabrication of each type throughout the treatment;Evaluate the patient's satisfaction and comfort level after 12 weeks of intervention compared to the baseline, using patient satisfaction and comfort questionnaires | — |
Countries
Brazil
Contacts
Public ContactJuliana de Oliveira
Universidade de São Paulo - Faculdade de Odontologia
Outcome results
None listed