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Completed

NCT Number: NCT05883982

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Maxillofacial Surgery

Kielce, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

I-PRF injection

Procedure

Intra-articular I-PRF injection to temporomandibular joint cavity

Primary outcomes

  1. Articular pain

    Time frame: 0 - 6 months

    Temporomandibular joint pain intensity on Visual Analogue Scale (form "0" - no pain to "10" - worst pain)

  2. Mandibular mobility

    Time frame: 0 - 6 months

    Range of mandibular abduction (between incisal edges, in mm)

Sponsors and collaborators

Lead sponsor

Hospital of the Ministry of Interior, Kielce, Poland

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 1, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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