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Intra-Articular PRP Versus Dexamethasone for TMJ Internal Derangement

2. juli 2026 opdateret af: Hussein Salam Abdulraheem Twayej, University Of Anbar

Evaluation of the Efficacy of Intra-Articular Injection of Platelet-Rich Plasma Versus Dexamethasone With Local Anaesthetic in the Treatment of Internal Derangement of the Temporomandibular Joint: A Randomised Controlled Trial

This study looked at whether an injection into the jaw joint (temporomandibular joint, or TMJ) can help people who have pain, clicking, and difficulty opening their mouth due to a slipped joint disc. Thirty patients were randomly assigned to receive one of three injections: platelet-rich plasma (PRP, made from the patient's own blood), a steroid medication (dexamethasone) with a local anesthetic, or a saline (salt water) injection as a comparison. Pain, joint clicking, and mouth opening were measured before the injection and one week later. The study found that both PRP and the steroid injection reduced pain and clicking more than saline, and PRP also improved how wide patients could open their mouth.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a prospective, parallel-group, three-arm randomised controlled trial conducted at the outpatient clinics of the Maxillofacial and Oral Surgery Division, College of Dentistry, University of Anbar, Ramadi, Iraq. Thirty temporomandibular joints (30 patients) with clinically diagnosed disc displacement with reduction, per DC/TMD Axis I criteria, were randomised 1:1:1 by an independent statistician using a computer-generated sequence, with allocation concealed via sequentially numbered opaque envelopes. The outcome assessor was blinded to treatment allocation throughout follow-up. Patients in the dexamethasone and saline arms were not informed of their specific assignment; full blinding was not feasible for the PRP arm due to the visible blood draw and processing required. All three injections used an identical preauricular approach, injection site, needle gauge, and volume (1 mL) to standardise the procedural experience across groups. Within- and between-group differences were analysed using the Wilcoxon signed-rank test and Kruskal-Wallis test with Dunn post-hoc comparisons. This trial was registered retrospectively after enrolment and follow-up were complete.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Irak
    • Al Najaf
      • Ramadi, Al Najaf, Irak, 54001
        • College of Dentistry, University of Anbar

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
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Inclusion Criteria:
  • Skeletally mature patients aged 18 years or older
  • Symptomatic TMJ internal derangement in the form of disc displacement with reduction (DDwR), diagnosed using DC/TMD Axis I clinical criteria
  • TMJ arthralgia confirmed by pain reproduced on palpation or provoked by jaw movement
  • Clicking sound detectable on palpation or auscultation during opening and closing movements
  • Elimination or marked reduction of the click on mouth opening from a protruded position

Exclusion Criteria:

  • Intra-articular injection within the previous six months
  • Systemic inflammatory arthropathy
  • Coagulopathy
  • Active local infection
  • Low platelet count
  • Ongoing antiplatelet or anticoagulant therapy
  • Pregnancy

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PRP
Single intra-articular injection of 0.6 mL leukocyte-poor platelet-rich plasma (PRP) into the superior joint space via a preauricular approach.
Biologisk: Platelet-Rich Plasma (PRP)
Autologous platelet-rich plasma (1 mL) prepared from the patient's own venous blood by centrifugation, injected into the superior joint space of the temporomandibular joint under a standardised preauricular approach.
Aktiv komparator: Dexamethasone + Local Anaesthetic
Single intra-articular injection of dexamethasone 4 mg (0.5 mL) combined with lidocaine 2% (0.5 mL), total 1 mL, into the superior joint space.
Medicin: Dexamethasone with Local Anaesthetic
Intra-articular injection (1 mL) of dexamethasone combined with a local anaesthetic, delivered into the superior joint space of the temporomandibular joint using the same standardised preauricular approach as the other study arms.
Placebo komparator: Normal Saline (Control)
Single intra-articular injection of 1 mL sterile 0.9% sodium chloride into the superior joint space, replicating the full procedural experience without an active agent.
Andet: Normal Saline (Placebo)
Intra-articular injection (1 mL) of normal saline solution into the superior joint space of the temporomandibular joint, serving as the placebo control, using the same standardised preauricular approach as the other study arms.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Intensity (VAS)
Tidsramme: Baseline and 1 week post-injection
Pain intensity rated on a 10-cm visual analogue scale (0=no pain, 10=worst imaginable pain), reflecting the most intense pain during function.
Baseline and 1 week post-injection

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Joint Sound (Clicking)
Tidsramme: Baseline and 1 week post-injection
Joint sound graded by a blinded assessor on a 3-point ordinal scale: 0=no clicking, 1=clicking detectable on palpation only, 2=clearly audible clicking.
Baseline and 1 week post-injection
Change in Maximum Interincisal Opening (MIO)
Tidsramme: Baseline and 1 week post-injection
Maximum interincisal opening measured in millimetres between upper and lower central incisors at maximum voluntary mouth opening.
Baseline and 1 week post-injection

Samarbejdspartnere og efterforskere

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

Sponsor

University Of Anbar

Efterforskere

  • Ledende efterforsker: Sabah Alheeti, BDS, CABMS, FIBMS, Oral and Maxillofacial Surgery Department / College of Dentistry / University of Anbar

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)

10. december 2025

Primær færdiggørelse (Faktiske)

9. april 2026

Studieafslutning (Faktiske)

9. april 2026

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UoAnbar-TMJ-PRP-2025
  • 141 (Anden identifikator: University of Anbar Ethical Approval Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

"The dataset supporting the conclusions of this article may be requested from the corresponding author"

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Kliniske forsøg med Temporomandibulære ledlidelser

Kliniske forsøg med Platelet-Rich Plasma (PRP)

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Betingelser

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