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CompletedNCT05883982Updated Sep 15, 2025

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

A Phase 2 interventional study of I-PRF injection in Temporomandibular Joint Disorders and Temporomandibular Joint Pain, sponsored by Hospital of the Ministry of Interior, Kielce, Poland. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Hospital of the Ministry of Interior, Kielce, Poland · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Pain
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's enrollment of 49 is close to the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Hospital of the Ministry of Interior, Kielce, Poland is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • bleeding diathesis;
  • mental illness;
  • temporomandibular joint prosthesis;
  • temporomandibular joint ankylosis;
  • skin disease of the preauricular area of the affected side.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    I-PRF

    Patients receiving I-PRF injections into temporomandibular joints.

    Procedure: I-PRF injection

Interventions

  • ProcedureI-PRF injection

    Intra-articular I-PRF injection to temporomandibular joint cavity

06

What researchers measure

Primary outcomes

  1. Articular pain

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

    Time frame: 0 - 6 months

  2. Mandibular mobility

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

    Time frame: 0 - 6 months

07

Study locations

1 site
  • Department of Maxillofacial Surgery
    Kielce, Poland
08

References and documents

Publications

  • Sielski M, Checinska K, Turosz N, Checinski M, Sikora M. Single intra-articular administration of injectable platelet-rich fibrin (I-PRF) in alleviating temporomandibular joint pain: A pilot clinical trial. Dent Med Probl. 2025 Jan-Feb;62(1):187-192. doi: 10.17219/dmp/188273. PubMed 40043084 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05883982
Lead sponsor
Hospital of the Ministry of Interior, Kielce, Poland
Responsible party
Sponsor
First posted
Jun 1, 2023
Start date
Jun 1, 2023
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025
Last update
Sep 15, 2025

Study contacts

Maciej Sikora, dr hab.
study chair · Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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