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NCT Number: NCT07691684

Intra-Articular PRP Versus Dexamethasone for TMJ Internal Derangement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, University of Anbar

Ramadi, Al Najaf, 54001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Platelet-Rich Plasma (PRP)

Biological

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.

Dexamethasone with Local Anaesthetic

Drug

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.

Normal Saline (Placebo)

Other

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.

Primary outcomes

  1. Change in Pain Intensity (VAS)

    Time frame: 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.

Secondary outcomes

  1. Change in Joint Sound (Clicking)

    Time frame: 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.

  2. Change in Maximum Interincisal Opening (MIO)

    Time frame: Baseline and 1 week post-injection

    Maximum interincisal opening measured in millimetres between upper and lower central incisors at maximum voluntary mouth opening.

Sponsors and collaborators

Lead sponsor

University Of Anbar

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

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.

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