PRP vs HA Intra-articular Injections in TMDs

NCT06530745 | Completed Phase 4

• 1 other identifier: CT/2024/1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Pain

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

PRP receiving group

EXPERIMENTAL

Patients receiving platelet-rich plasma injections into temporomandibular joints.

Procedure: Platelet-rich plasma (PRP) injection

HA receiving group

ACTIVE COMPARATOR

Patients receiving hyaluronic acid injections into temporomandibular joints.

Procedure: Hyaluronic acid (HA) injection

Interventions

Hyaluronic acid (HA) injection PROCEDURE

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

HA receiving group

Platelet-rich plasma (PRP) injection 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

PRP receiving group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital of the Ministry of Interior, Kielce, Poland: lead

Study Sites (1)

Department of Maxillofacial Surgery

Kielce, Poland

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Hyaluronic Acid; Injections

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Maciej Sikora, dr hab.

  Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: July 31, 2024
• Study Start: July 18, 2024
• Primary Completion: July 29, 2024
• Study Completion: August 8, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)