K07.6
Conditions
Interventions
Group 1: Control group: Patients (diagnosed with arthropathy) receive a conventional stabilization splint, manufactured according to mean values. Prospective follow-up is planed over a period of 12 we
Sponsors
ZZMK (Carolinum) der Johann Wolfgang Goethe-Universität, Poliklinik für Zahnärztliche Prothetik
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Arthropathy according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) - Indication for a stabilization splint - Natural, complete dentition (everywhere up to the second molar) or corresponding fixed dentures
Exclusion criteria
Exclusion criteria: - Pregnant women - Incapacitated patients (e.g. due to dementia) - Psychosomatic comorbidities - People with a removable denture in the upper or lower jaw - Indication for a positioning splint - Only myopathy without arthropathy - Acute events such as joint effusion or trauma - Addictions (alcohol, drugs, analgesics) - Pain disorders such as fibromyalgia syndrome, neuropathic pain, trigeminal neuralgia or atypical facial pain - Diseases and other criteria that generally make an MRI scan impossible: • Pacemaker • Neurostimulator or drug pump • Metal parts in the body (e.g. splinters, clips or staples after operations, cochlear implants) that prevent an MRI • Fear of tight spaces (claustrophobia) • Severely impaired cardiovascular health disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of the VAS (Visual Analog Scale)-difference for quantifying the pain reduction before and after splint therapy is assessed. Measurement times: Before therapy, after 3 weeks, 6 weeks and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The oral health-related quality of life is measured (Questionnaire OHIP-G 14). 2. The change in the condyle-disc-fossa-relation achieved by the therapeutic position is measured on the basis of the metric evaluation of magnetic resonance images. Depending on further questionnaires, following parameters are assessed: 3. pain-related symptoms ("Diagnostic Criteria for Temporomandibular Disorders-Symptom Questionnaire", "Pain representation", "Jaw Functional Limitation Scale (JFLS-8)," Fonseca-G ", Pain reduction using Numerical Analog Scales (GCS)), 4. the sleep quality (Pittsburgh Sleep Quality Index (PSQI)), 5. the activities during sleep and while awake ((Oral Behaviors Checklist) (OBC)), 6. the wearing comfort of the splints (Numerical Rating Scale = NRS). | — |
Countries
Germany
Contacts
Public ContactTugba Zahn
ZZMK (Carolinum) der Johann Wolfgang Goethe-Universität, Poliklinik für Zahnärztliche Prothetik
Outcome results
None listed