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Intra-articular Injection for the Relief of Temporomandibular Joint Pain

30. april 2026 opdateret af: 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?

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Andet: 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.
Aktiv komparator: 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
Andet: 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.
Aktiv komparator: 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
Andet: 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.
Placebo komparator: 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
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
pain intensity
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
crepitus sounds
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Efterforskere

  • Ledende efterforsker: Mohamed MA el saadany, master, mohamed_mostafa@dentistry.cu.edu.eg

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2024

Primær færdiggørelse (Faktiske)

25. august 2025

Studieafslutning (Faktiske)

25. oktober 2025

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Intra articular injections

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The data is available with the corresponding author on reasonable request

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