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Intra-Articular PRP Versus Dexamethasone for TMJ Internal Derangement

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07691684
Enrollment
30
Registered
2026-07-09
Start date
2025-12-10
Completion date
2026-04-09
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Internal Derangement

Keywords

Dexamethasone, Platelet-Rich Plasma, Intra-articular Injection, TMJ, Randomized Controlled Trial

Brief summary

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.

Detailed description

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.

Interventions

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.

DRUGDexamethasone 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.

OTHERNormal 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.

Sponsors

University Of Anbar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

"Outcome assessor was fully blinded throughout follow-up. Participants in the dexamethasone and saline arms were blinded to allocation; full blinding was not feasible in the PRP arm due to the visible blood-draw and processing procedure

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in Joint Sound (Clicking)Baseline and 1 week post-injectionJoint 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.
Change in Maximum Interincisal Opening (MIO)Baseline and 1 week post-injectionMaximum interincisal opening measured in millimetres between upper and lower central incisors at maximum voluntary mouth opening.

Countries

Iraq

Contacts

PRINCIPAL_INVESTIGATORSabah Alheeti, BDS, CABMS, FIBMS

Oral and Maxillofacial Surgery Department / College of Dentistry / University of Anbar

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026