Therapeutic effect of fully digitally manufactured occlusal splints using individual patient parameters electronically determined by means of the DMD-System® and digital determination of the therapeutic position vs. conventional stabilization splints-a clinical prospective randomized double-blind study

Phase 4

Recruiting

Conditions: K07.6
Temporomandibular joint disorders

Registration Number: DRKS00025463

Lead Sponsor: ZZMK (Carolinum) der Johann Wolfgang Goethe-Universität, Poliklinik für Zahnärztliche Prothetik

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 123

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

- 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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of the VAS (Visual Analog Scale)-difference for quantifying the pain reduction before and after splint therapy is assessed.<br>Measurement times:<br>Before therapy,<br>after 3 weeks, 6 weeks and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
1. The oral health-related quality of life is measured (Questionnaire OHIP-G 14).<br>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.<br><br>Depending on further questionnaires, following parameters are assessed:<br>3. pain-related symptoms <br>(Diagnostic Criteria for Temporomandibular Disorders-Symptom Questionnaire, Pain representation, Jaw Functional Limitation Scale (JFLS-8), Fonseca-G , Pain reduction using Numerical Analog Scales (GCS)),<br>4. the sleep quality (Pittsburgh Sleep Quality Index (PSQI)),<br>5. the activities during sleep and while awake ((Oral Behaviors Checklist) (OBC)),<br>6. the wearing comfort of the splints (Numerical Rating Scale = NRS).