Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction

Study Overview
=================
Brief Summary
-----------------
The aim of the study will be to analyze the results of injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. The treatment will consist in the administration of autologous blood products into the cavities of the temporomandibular joints.

Detailed Description
-----------------
The aim of the study is to analyze the results of injection treatment in patients diagnosed with temporomandibular joint dysfunction manifested by pain and/or limited jaw mobility. The analyzed treatment will consist in the administration of autologous blood products into the cavities of the temporomandibular joints. We intend to conduct a prospective study without a control group. Patients suffering from pain in the temporomandibular joints and/or limited jaw mobility, in whom injection treatment is the treatment of choice, and patients in whom first-line therapies (pharmacotherapy, physiotherapy, splint therapy) did not bring the desired results, and intra-articular injections are a generally accepted continuation of the therapeutic protocol. Qualified patients will be treated with autologous blood products (injectable platelet-rich fibrin). Data from specialist literature support the safety and effectiveness of administering the above-mentioned substance to the cavities of the temporomandibular joints. The use of blood products in the form of intra-articular injections is medically justified both in the case of pain in the temporomandibular joints and/or in clinical conditions with limited jaw mobility. Currently available scientific publications on the comparison of the effectiveness of therapy with the use of various autologous substances are not numerous and do not give a clear answer to the question of what therapeutic protocol (type of substance, dose, number of administrations, joint compartment) is the most effective in the given observation period. This study aims to clarify some of these issues in regard to the above-mentioned blood product, and thus to obtain valuable clinical data that may help clinicians in choosing the appropriate use of intra-articular injections in patients with temporomandibular joint dysfunction.

Official Title
-----------------
Analysis of the Results of Treatment With Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction.

Conditions
-----------------
Temporomandibular Joint Disorders, Temporomandibular Joint Pain

Intervention / Treatment
-----------------
* Procedure: I-PRF injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18; informed consent to participate in the study; the possibility of discontinuing the current treatment of the temporomandibular joints; generally accepted indications for injection therapy. Exclusion Criteria: bleeding diathesis; mental illness; temporomandibular joint prosthesis; temporomandibular joint ankylosis; skin disease of the preauricular area of the affected side.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: We do not choose to create a placebo group or treatment groups other than intra-articular injections. In qualified patients, the administration of the substance into the temporomandibular joint cavity will be the treatment of choice or the generally accepted continuation of therapy in which the first-line treatment (pharmacotherapy, physiotherapy, splint therapy) turned out to be ineffective.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-PRF<br>Patients receiving I-PRF injections into temporomandibular joints. | Procedure: I-PRF injection<br>* Intra-articular I-PRF injection to temporomandibular joint cavity<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Articular pain | Temporomandibular joint pain intensity on Visual Analogue Scale (form 0 - no pain to 10 - worst pain) | 0 - 6 months | 
| Mandibular mobility | Range of mandibular abduction (between incisal edges, in mm) | 0 - 6 months |