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
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders
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.
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
NCT ID
NCT05883982
First Posted
May 22, 2023
Last Updated
June 4, 2023
Sponsor
Hospital of the Ministry of Interior, Kielce, Poland
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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