PRP vs HA Intra-articular Injections in TMDs

Quintuple Intra-Articular Hyaluronic Acid (HA) Improves and Platelet-Rich Plasma (PRP) Does Not Affect Mandibular Mobility in Temporomandibular Joint (TMJ) Disorders: A Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Pain
• Intervention / Treatment: Procedure: Platelet-rich plasma (PRP) injection; Procedure: Hyaluronic acid (HA) injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Kielce, Poland
    • Department of Maxillofacial Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP receiving group; Patients receiving platelet-rich plasma injections into temporomandibular joints.	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
Active Comparator: HA receiving group; Patients receiving hyaluronic acid injections into temporomandibular joints.	Procedure: Hyaluronic acid (HA) injection; 2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mandibular abduction	Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)	0 - 6 months
Mandibular protrusion	Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)	0 - 6 months
Mandibular right movement	Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)	0 - 6 months
Mandibular left movement	Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)	0 - 6 months

Collaborators and Investigators

• Sponsor: Hospital of the Ministry of Interior, Kielce, Poland
• Investigators: Study Chair: Maciej Sikora, dr hab., Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Myofascial Pain Syndromes; Arthralgia; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: CT/2024/1

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
• product manufactured in and exported from the U.S.: No