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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Temporomandibular Joint Disorders Temporomandibular Joint Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I-PRF

Patients receiving I-PRF injections into temporomandibular joints.

Group Type EXPERIMENTAL

I-PRF injection

Intervention Type PROCEDURE

Intra-articular I-PRF injection to temporomandibular joint cavity

Interventions

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I-PRF injection

Intra-articular I-PRF injection to temporomandibular joint cavity

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No