Effectiveness of iPRF Injections in Temporomandibular Joints Degeneration Management

October 2, 2022 updated by: Joanna Smardz, Wroclaw Medical University

Assessment of the Effectiveness of Intra-articular Injectable Platelet-rich Fibrin (iPRF) Injections in the Management of Mild and Moderate Degeneration of the Temporomandibular Joints

The aim of the study is to evaluate the effectiveness of intra-articular platelet-rich fibrin (iPRF) injections in the management of moderate and mild cases of degeneration of the temporomandibular joints. This randomized, two-arm controlled trial will involve 42 adult patients diagnosed with mild or moderate degeneration of the temporomandibular joints on the basis of clinical examination and magnetic resonance imaging or computed tomography. Qualified study participants will be randomly assigned to two groups. The studied group will receive two injections of iPRF with an interval of 30 days, while the control group will receive injections of platelet-rich plasma (PRP) during this time. Each subject will be tested on the day of the first injection (D0), on the day of the second injection (D30), and then 60 (D60) and 12 (D120) days after the first injection using MRI/CT, Doppler Hi-dop, clinical examination and surveys.

Study Overview

Detailed Description

Background: The term temporomandibular disorders is used to describe a wide spectrum of functional modifications and pathological conditions involving the temporomandibular joints, masticatory muscles and other surrounding structures. Temporomandibular disorders are the second most common cause of pain symptoms in the craniofacial area. It is estimated that they may affect up to 56% of the adult Polish population. One of the most common forms of temporomandibular disorders are intra-articular abnormalities. They can lead to degeneration within the articular surfaces and articular disc of the joints. The treatment of degeneration of the temporomandibular joints is a great therapeutic challenge. There are scientific reports suggesting that one of the effective methods may be intra-articular injections. Injectable platelet-rich fibrin (iPRF) is an autologous material obtained from human blood, which contains a high concentration of inactivated platelets, white blood cells and mesenchymal stem cells. After injection into the tissues, it initiates natural repair processes. Despite the fairly wide possibilities of application, this method has not yet been tested in terms of its use in the treatment of degeneration of the temporomandibular joints.

Aim: The aim of the study is to evaluate the effectiveness of intra-articular platelet-rich fibrin injections in the management of moderate and mild cases of degeneration of the temporomandibular joints.

Material and methods: A randomized, two-arm controlled trial will involve 42 adult patients diagnosed with mild or moderate degeneration of the temporomandibular joints on the basis of clinical examination and magnetic resonance imaging or computed tomography. Criteria for exclusion from the study will include: severe hematologic and/or neurological disorder; rheumatoid arthritis; septic arthritis; polymyalgia rheumatica; gout; Paget's disease; osteonecrosis; connective tissue disease; malignant disease; vasculitis; any previous temporomandibular joint invasive treatment; any current temporomandibular joint conservative or invasive treatment; patients who had used oral, parenteral or intra-articular corticosteroids in the 3 months prior to the first injection; previous or current radiotherapy of head and neck; pregnancy or lactation; presence of severe mental disorders; drug and/or alcohol addiction; presence of local contraindications for injection therapy; patients with needle phobia; presence of hypersensitivity to substances to be used in the study.

Qualified study participants will be randomly assigned to two groups. The studied group will receive two injections of iPRF with an interval of 30 days, while the control group will receive injections of platelet-rich plasma (PRP) during this time. The use of PRP has been already described in the scientific literature as being effective in the treatment of joint degeneration. Each subject will be tested on the day of the first injection (D0), on the day of the second injection (D30), and then 60 (D60) and 12 (D120) days after the first injection using the following methods:

  1. Magnetic resonance imaging of the temporomandibular joints (D0)
  2. Examination with the Doppler Hi-dop (D0, D30, D60, D120)
  3. Examination of the mandibular mobility ranges with a professional ruler (D0, D30, D60, D120)
  4. Clinical examination according to diagnostic criteria for temporomandibular disorders - DC / TMD International Examination Form (D0, D120)
  5. Surveys: Short Form 36 (SF-36), General Oral Health Assessment Index (GOHAI (HRQoL)) (D0, D60, D120), Jaw Functional Limitation Scale-20 (D0, D30, D60, D120), TMD Pain Screener (D0, D30, D60, D120) Pain Numerical Rating Scale (D0, D30, D60, D120), Graded Chronic Pain Scale (DO, D30, D60, D120).

The collected data will then be subjected to statistical analysis in order to verify the research hypothesis and capture statistically significant relationships.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Wrocław, Poland
        • Wroclaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 18 and 80 years old
  • mild to moderate degenerative temporomandibular joint disease based on DC/TMD protocol and MRI/CT
  • agreement to take part in the study

Exclusion Criteria:

  • severe hematologic and/or neurological disorder
  • rheumatoid arthritis
  • septic arthritis
  • polymyalgia rheumatica
  • gout
  • Paget's disease
  • osteonecrosis
  • connective tissue disease
  • malignant disease
  • vasculitis
  • any previous temporomandibular joint (TMJ) invasive treatment
  • any current temporomandibular joint (TMJ) conservative or invasive treatment
  • patients who had used oral, parenteral or intra-articular corticosteroids in the 3 months prior to the first injection
  • previous or current radiotherapy of head and neck
  • pregnancy or lactation
  • presence of severe mental disorders
  • drug and/or alcohol addiction
  • presence of local contraindications for injection therapy
  • patients with needle phobia
  • presence of hypersensitivity to substances to be used in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injectable platelet-rich fibrin injection
Each of the participants from iPRF injection group will receive two injections of iPRF with an interval of 30 days.
Intra-articular injection of injectable platelet-rich fibrin into temporomandibular joint/joints with diagnosed mild to moderate degenerative joint disease.
Other Names:
  • iPRF
Active Comparator: Platelet-rich plasma injection
Each of the participants from PRP injection group will receive two injections of PRP with an interval of 30 days.
Intra-articular injection of platelet-rich plasma into temporomandibular joint/joints with diagnosed mild to moderate degenerative joint disease.
Other Names:
  • PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effectiveness of intra-articular platelet-rich fibrin (iPRF) injections on TMD symptoms reduction assessed by clinical examination in accordance to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) protocol with DC/TMD examination form.
Time Frame: Up to 3 months
Each patient will undergo DC/TMD protocol-based clinical examination before and after injections using DC/TMD examination form assessing incidence of pain and disfunction in temporomandibular joints, masticatory muscles and surrounding structures.
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effectiveness of intra-articular platelet-rich fibrin (iPRF) injections on the jaw mobility assessed by jaw mobility measurement with professional ruler (millimeters).
Time Frame: Up to 3 months
Each participant will undergo jaw mobility assessment (measured with millimeters) with the use of professional ruler before and after injections.
Up to 3 months
The influence of intra-articular platelet-rich fibrin (iPRF) injections on intra-articular sounds assessed using Doppler Hi-dop (Hz).
Time Frame: Up to 3 months
Each participant will undergo Doppler Hi-dop examination (measured in Hz) before and after injections.
Up to 3 months
The influence of intra-articular platelet-rich fibrin (iPRF) injections on pain in temporomandibular area assessed using Graded Chronic Pain Scale.
Time Frame: Up to 3 months
Each participant will fill in Graded Chronic Pain Scale before and after injections. Scoring Criteria for Grading Chronic Pain Severity: Characteristic Pain Intensity is a 0 to 100 score derived from Questions 1 through 3:Mean (Pain Right Now, Worst Pain, Average Pain) X 10. Disability Score is 0 to 100score derived from Questions 4 through 6:Mean (Daily Activities, Social Activities, Work Activities) X 10. Disability Points: Add the indicated points for Disability Days (Question 7)and for Disability Score. Classification: GRADE 0- No TMD pain in prior 6 months. GRADE I-Low Intensity Characteristic Pain Intensity<50, Low Disability<3 Disability Point. GRADE II -High Intensity Characteristic Pain Intensity >50, LowDisability<3 Disability Points. GRADE III- High Disability3 to 4 Disability Points, Moderately Limiting (Regardless of Characteristic Pain Intensity). GRADE IV- High Disability 5 to 6 Disability Points, Severely Limiting (Regardless of Characteristic Pain Intensity).
Up to 3 months
The influence of intra-articular platelet-rich fibrin (iPRF) injections on reduction of pain in temporomandibular area assessed using TMD pain screener questionnaire.
Time Frame: Up to 3 months
Each participant will fill in TMD pain screener questionnaire before and after injections. The first item has scores of 0-2 (a=0, b=1, c=2), while the remaining items are scored simply as a=0, b=1. A sum is computed. Higher scores mean more intense pain.
Up to 3 months
The influence of intra-articular platelet-rich fibrin (iPRF) injections on reduction of pain in temporomandibular joints assessed using Pain Numerical Rating Scale.
Time Frame: Up to 3 months
Each participant will be asked to assess the pain during temporomandibular joints palpation using Pain Numerical Rating Scale before and after injections. It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Up to 3 months
The influence of intra-articular platelet-rich fibrin (iPRF) injections on jaw functionality assessed using Jaw Functional Limitation Scale-20.
Time Frame: Up to 3 months
Each participant will fill in Jaw Functional Limitation Scale-20 before and after injections. It is organ-specific instrument comprising 3 constructs for assessing functional status of the masticatory system; the 3 scales exhibit properties that are ideal for both research and patient evaluation in patient groups with a range of functional limitations of the jaw.
Up to 3 months
The influence of intra-articular platelet-rich fibrin (iPRF) injections on quality of life using GOHAI questionnaire.
Time Frame: Up to 3 months
Each participant will fill in GOHAI questionnaire before and after injections. The GOHAI assesses self-perceived oral health through 12 questions that explore the pain, discomfort, dysfunctions and the psychosocial impacts of dental diseases.
Up to 3 months
The influence of intra-articular platelet-rich fibrin (iPRF) injections on quality of life using Short Form 36 questionnaire.
Time Frame: Up to 3 months
Each participant will fill in Short Form 36 (SF-36) questionnaire before and after injections. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mieszko Wieckiewicz, Prof., Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 2, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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