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

Primary Purpose

Temporomandibular Joint Disorders, Temporomandibular Joint Pain

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
I-PRF injection
Sponsored by
Hospital of the Ministry of Interior, Kielce, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    I-PRF

    Arm Description

    Patients receiving I-PRF injections into temporomandibular joints.

    Outcomes

    Primary Outcome Measures

    Articular pain
    Temporomandibular joint pain intensity on Visual Analogue Scale (form "0" - no pain to "10" - worst pain)
    Mandibular mobility
    Range of mandibular abduction (between incisal edges, in mm)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2023
    Last Updated
    June 4, 2023
    Sponsor
    Hospital of the Ministry of Interior, Kielce, Poland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05883982
    Brief Title
    Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction
    Official Title
    Analysis of the Results of Treatment With Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital of the Ministry of Interior, Kielce, Poland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Joint Disorders, Temporomandibular Joint Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    I-PRF
    Arm Type
    Experimental
    Arm Description
    Patients receiving I-PRF injections into temporomandibular joints.
    Intervention Type
    Procedure
    Intervention Name(s)
    I-PRF injection
    Intervention Description
    Intra-articular I-PRF injection to temporomandibular joint cavity
    Primary Outcome Measure Information:
    Title
    Articular pain
    Description
    Temporomandibular joint pain intensity on Visual Analogue Scale (form "0" - no pain to "10" - worst pain)
    Time Frame
    0 - 6 months
    Title
    Mandibular mobility
    Description
    Range of mandibular abduction (between incisal edges, in mm)
    Time Frame
    0 - 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maciej Sikora, dr hab.
    Phone
    +48 41 260 55 85
    Email
    sikora-maciej@wp.pl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maciej Sikora, dr hab.
    Organizational Affiliation
    Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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