Temporomandibular Disorders K07.6
Conditions
Interventions
Group 1: Injection of i-PRF into the temporomandibular joints to be treated.
The intensive phase comprises four treatments, which are performed at an interval of one to two weeks. This short interval
Sponsors
Goethe Universität Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Only patients with a diagnosed Temporomandibular Joint Disorder will be included in the study. A baseline MRI must be performed prior to study participation to assess the joint structure and to rule out major injuries.
Exclusion criteria
Exclusion criteria: Patients with acute infections or inflammatory processes in the temporomandibular joint will be excluded from participation, as these could represent an independent influencing factor on the therapeutic outcomes. Similarly, patients who have already received surgical interventions or invasive therapies in the TMJ area are excluded, as this could lead to structural changes that influence the results of the PRF therapy. Furthermore, patients with systemic diseases that affect the blood clotting mechanism will not be included in the study, as this could result in altered PRF quality. Additionally, patients with poorly controlled diabetes mellitus and severe autoimmune diseases will be excluded. Patients who regularly take medication that affects platelet function or blood coagulation will also be excluded from the study. This specifically includes NSAIDs, corticosteroids, and blood-thinning medications such as ASA, or clopidogrel. This could alter the quality of the PRF and the release of growth factors, meaning the intended regenerative effect may not be reliably assessed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Does the intra-articular injection of PRF in patients with Temporomandibular Joint Disorders (TMD) lead to a significant reduction in pain intensity (measured by the Visual Analog Scale, VAS). The clinical endpoints are used for monitoring success. They will be reassessed after the completion of the intensive phase, as well as after three and six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Does the maximum mouth opening improve after PRF therapy compared to the baseline situation as a measure of functional improvement? (measured with a caliper) Is there a functional limitation in food intake and a subjectively perceived impairment in daily life? (assessed using a questionnaire) To what extent does the therapy influence the need for analgesics regarding preparation, dosage, and frequency of intake throughout the course of the study? (assessed and compared using a questionnaire) Do the clinically detectable joint noises and the associated functional disorders decrease due to the PRF treatment? (determined and documented by the treating physician, possibly with the aid of a stethoscope, and with the patient's respective assessment) Can MRI examinations prove structural improvements or stabilizations in the temporomandibular joint after PRF therapy? (a repeat MRI examination with subsequent findings may be ordered in individual cases) How is the patients' subjective satisfaction with the treatment rated? (determined using a questionnaire) These clinical endpoints are used for monitoring success. They will all be reassessed after the completion of the intensive phase, as well as after three and six months. | — |
Countries
Germany
Contacts
Public ContactPhilipp Thoenissen
Goethe Universität Frankfurt / Klinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
Outcome results
None listed