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

Temporomandibular Joint Disorders Clinical Trial

Official title:

Analysis of the Results of Treatment With Intra-articular I-PRF Injections in Patients With Temporomandibular Joint Dysfunction.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05883982
• Other study ID #: CT/2022/1
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Arthralgia
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Temporomandibular Joint Pain

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