Skip to main content
OpenTrials
Completed

NCT Number: NCT06530745

PRP vs HA Intra-articular Injections in TMDs

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Maxillofacial Surgery

Kielce, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic acid (HA) injection

Procedure

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

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

Primary outcomes

  1. Mandibular abduction

    Time frame: 0 - 6 months

    Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)

  2. Mandibular protrusion

    Time frame: 0 - 6 months

    Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)

  3. Mandibular right movement

    Time frame: 0 - 6 months

    Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)

  4. Mandibular left movement

    Time frame: 0 - 6 months

    Range of mandibular abduction between anthropometric points Incision superius (Is) and Incision inferius (Ii)

Sponsors and collaborators

Lead sponsor

Hospital of the Ministry of Interior, Kielce, Poland

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.