PRP vs HA Intra-articular Injections in TMDs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-18

Study Completion Date

2024-08-08

Brief Summary

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This clinical trial aims to compare the multidirectional mandibular mobility following the treatment of TMJ disorders with same-protocol intra-articular injections of PRP and HA. It is questioned whether there is direct clinical evidence of the superiority of PRP or HA in the injection treatment of TMJ disorders.

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Detailed Description

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This study was designed as a two-arm equal-allocation clinical trial with a non-concurrent active treatment control. The study group consisted of consecutive patients receiving PRP injections into the TMJ cavities. The control group consisted of the same number of patients who received HA according to the same protocol. Controls were recruited consecutively, men and women separately, to maintain a consistent male-to-female ratio. The main condition for recruitment was the diagnosis of TMJ pain by a specialist in orthodontics or dental prosthetics and, on this basis, a referral for injection treatment. TMJ pain was diagnosed under the ICOP 2020 guidelines. The treatment was performed at the Maxillofacial Surgery Clinic in Kielce, Poland. The study group received PRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 (Neuation Technologies Pvt. Ltd, Gujarat, India). The control group received 2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria). In both groups, 0.4 mL of the solution was injected per joint.

Conditions

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Temporomandibular Joint Disorders Temporomandibular Joint Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study was designed as a two-arm equal-allocation clinical trial with a non-concurrent active treatment control.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRP receiving group

Patients receiving platelet-rich plasma injections into temporomandibular joints.

Group Type EXPERIMENTAL

Platelet-rich plasma (PRP) injection

Intervention Type PROCEDURE

PRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 (Neuation Technologies Pvt. Ltd, Gujarat, India) injection

HA receiving group

Patients receiving hyaluronic acid injections into temporomandibular joints.

Group Type ACTIVE_COMPARATOR

Hyaluronic acid (HA) injection

Intervention Type PROCEDURE

2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria) injection

Interventions

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Hyaluronic acid (HA) injection

2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria) injection

Intervention Type PROCEDURE

Platelet-rich plasma (PRP) injection

PRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 (Neuation Technologies Pvt. Ltd, Gujarat, India) injection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ICOP 2020 diagnosis of TMJ pain;
* 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

* active cancer;
* hematopoietic system disease or bleeding diathesis;
* temporomandibular joint prosthesis;
* temporomandibular joint ankylosis;
* skin disease of the preauricular area of the affected side.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No