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

NCT05883982 | Completed Phase 2

• 1 other identifier: CT/2022/1
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

I-PRF

EXPERIMENTAL

Patients receiving I-PRF injections into temporomandibular joints.

Procedure: I-PRF injection

Interventions

I-PRF injection PROCEDURE

Intra-articular I-PRF injection to temporomandibular joint cavity

I-PRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital of the Ministry of Interior, Kielce, Poland: lead

Study Sites (1)

Department of Maxillofacial Surgery

Kielce, Poland

Location

Related Publications (1)

• 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.

  PMID: 40043084 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Maciej Sikora, dr hab.

  Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)