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

Sponsor
Hospital of the Ministry of Interior, Kielce, Poland (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05883982
Collaborator
(none)
40
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: I-PRF injection
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Analysis of the Results of Treatment With Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction.
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: I-PRF

Patients receiving I-PRF injections into temporomandibular joints.

Procedure: I-PRF injection
Intra-articular I-PRF injection to temporomandibular joint cavity

Outcome Measures

Primary Outcome Measures

  1. Articular pain [0 - 6 months]

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

  2. Mandibular mobility [0 - 6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • bleeding diathesis;

  • mental illness;

  • temporomandibular joint prosthesis;

  • temporomandibular joint ankylosis;

  • skin disease of the preauricular area of the affected side.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital of the Ministry of Interior, Kielce, Poland

Investigators

  • Study Chair: Maciej Sikora, dr hab., Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital of the Ministry of Interior, Kielce, Poland
ClinicalTrials.gov Identifier:
NCT05883982
Other Study ID Numbers:
  • CT/2022/1
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome

Study Results

No Results Posted as of Jun 6, 2023