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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05883982
Other study ID # CT/2022/1
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2023
Est. completion date June 1, 2024

Study information

Verified date June 2023
Source Hospital of the Ministry of Interior, Kielce, Poland
Contact Maciej Sikora, dr hab.
Phone +48 41 260 55 85
Email sikora-maciej@wp.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date June 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital of the Ministry of Interior, Kielce, Poland

Outcome

Type Measure Description Time frame Safety issue
Primary Articular pain Temporomandibular joint pain intensity on Visual Analogue Scale (form "0" - no pain to "10" - worst pain) 0 - 6 months
Primary Mandibular mobility Range of mandibular abduction (between incisal edges, in mm) 0 - 6 months
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