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Intra-articular Injection for the Relief of Temporomandibular Joint Pain

30 aprile 2026 aggiornato da: mohamed mostafa abd el khalek mohamed, Cairo University

A Comparative Study on the Impact of Intra-articular Injections of Hyaluronic Acid, Platelet-rich Plasma and Triamcinolone Acetonide on the Relief of Temporomandibular Joint Pain

Which is more effective in the treatment of nonspecific temporomandibular osteoarthritis: platelet-rich plasma (PRP), hyaluronic acid, or triamcinolone acetonide?

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Osteoarthritis is a degenerative condition that affects the TMJ. This condition may affect other joints in the hands, feet, or spine. The progressive destruction of the fibrocartilage layers with or without bone destruction and loss of the synovial fluid leads eventually to the accumulation of the inflammatory mediators. And when the episodes of destruction exceed that of healing, the patients start to encounter cycles of pain, inflammation, earache, limitation of mouth opening, and loss of function. Many treatment modalities have been illustrated in the literature for the treatment of osteoarthritis. One of the most effective treatment modalities used is intra-articular injections.

The first treatment strategy in this research is intra-articular injections of hyaluronic acid. Hyaluronic acid is a high molecular weight glycosaminoglycan composed of repeated chains of disaccharides. HLA is considered a normal component of numerous body structures and body fluids, like the synovial fluid, and is conjugated with many processes, like tissue repair and inflammation. So many authors advocate its usefulness in the treatment of temporomandibular dysfunction and myofascial pain without any complications or adverse effects.

The second treatment arm will be used for corticosteroids as intra-articular injections, and that's because of their long-standing and powerful anti-inflammatory properties alone or with local anesthetics for relief or treatment of temporomandibular joint symptoms.

Platelet-rich plasma is concentrated from the patient's own blood sample by centrifugation. It was first introduced in maxillofacial and plastic surgery in 1990. It's claimed that it has many advantages because of its healing potential, cell recruitment, proliferation, and differentiation, which lead eventually to tissue repair.

In this research, we are going to compare the effectiveness of three treatment arms: platelet-rich plasma, hyaluronic acid, and triamcinolone acetonide.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

64

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Egitto
    • Cairo Governorate
      • Al Manyal, Cairo Governorate, Egitto, 11553
        • Faculty of Dentistry

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • 1. Patients with temporomandibular joint osteoarthritis with or without disc displacement.
  • 2. Age ≥ 18 years < 50

Exclusion Criteria:

  • 1. Previous TMJ surgery
  • 2. Medical history of blood-derived illness or any medication known to affect platelet function or concentration for a minimum of two weeks prior to treatment.
  • 3. specific osteoarthritis like rheumatoid arthritis or psoriatic arthritis.
  • 4. pregnant women or breastfeeding ones

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: platelet rich plasma(PRP)
  • The surgical field will be prepared using alcohol before injection.
  • The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
  • Auriculotemporal nerve block anesthesia will be performed.
  • An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP, and Patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months
Altro: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection
  • An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP in group I, 1 ml of triamcinolone acetonide 40 mg/ml in group II, 1 ml of hyaluronic acid (Hyalgan 20 mg/2 ml) in group III, or 1 ml of normal saline in group IV.
  • Patients will be evaluated after one week and 1 month, then at 3 months and 6 months.
Comparatore attivo: triamcinolone acetonide
  • The surgical field will be prepared using alcohol before injection.
  • The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
  • Auriculotemporal nerve block anesthesia will be performed.
  • An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of epirelefan (triamcinolone acetonide) 40 mg/ml, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months
Altro: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection
  • An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP in group I, 1 ml of triamcinolone acetonide 40 mg/ml in group II, 1 ml of hyaluronic acid (Hyalgan 20 mg/2 ml) in group III, or 1 ml of normal saline in group IV.
  • Patients will be evaluated after one week and 1 month, then at 3 months and 6 months.
Comparatore attivo: hyaluronic acid
  • The surgical field will be prepared using alcohol before injection.
  • The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
  • Auriculotemporal nerve block anesthesia will be performed.
  • An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of Hyalgan (hyaluronic acid) 20 mg/2 ml, and patients will be evaluated after one week, 1 month, and then 3 months. and 6 months
Altro: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection
  • An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP in group I, 1 ml of triamcinolone acetonide 40 mg/ml in group II, 1 ml of hyaluronic acid (Hyalgan 20 mg/2 ml) in group III, or 1 ml of normal saline in group IV.
  • Patients will be evaluated after one week and 1 month, then at 3 months and 6 months.
Comparatore placebo: saline(placebo)
  • The surgical field will be prepared using alcohol before injection.
  • The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line.
  • Auriculotemporal nerve block anesthesia will be performed.
  • An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of saline, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months
Altro: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection
  • An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP in group I, 1 ml of triamcinolone acetonide 40 mg/ml in group II, 1 ml of hyaluronic acid (Hyalgan 20 mg/2 ml) in group III, or 1 ml of normal saline in group IV.
  • Patients will be evaluated after one week and 1 month, then at 3 months and 6 months.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
pain intensity
Lasso di tempo: preoperative as baseline then after one week, 1 month, 3 months and 6 months
The patient's temporomandibular joint pain was felt by the patient on the visual analog scale from numbers 1 to 10.
preoperative as baseline then after one week, 1 month, 3 months and 6 months
pain-free mouth opening
Lasso di tempo: preoperative as baseline then after one week, 1 month, 3 months and 6 months
The maximum mouth opening measured with a caliper in millimeters.
preoperative as baseline then after one week, 1 month, 3 months and 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
crepitus sounds
Lasso di tempo: preoperative as baseline then after one week, 1 month, 3 months and 6 months
asking the patient at every appointment
preoperative as baseline then after one week, 1 month, 3 months and 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cairo University

Investigatori

  • Investigatore principale: Mohamed MA el saadany, master, mohamed_mostafa@dentistry.cu.edu.eg

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2024

Completamento primario (Effettivo)

25 agosto 2025

Completamento dello studio (Effettivo)

25 ottobre 2025

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Intra articular injections

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

The data is available with the corresponding author on reasonable request

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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