Intra-Articular PRP Versus Dexamethasone for TMJ Internal Derangement

NCT07691684 | Completed

• 2 other identifiers: UoAnbar-TMJ-PRP-2025141
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Joint Disorders; Temporomandibular Joint Internal Derangement

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (VAS)

  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

Secondary Outcomes (2)

• Change in Joint Sound (Clicking)

  Baseline and 1 week post-injection

• Change in Maximum Interincisal Opening (MIO)

  Baseline and 1 week post-injection

Study Arms (3)

PRP

EXPERIMENTAL

Single intra-articular injection of 0.6 mL leukocyte-poor platelet-rich plasma (PRP) into the superior joint space via a preauricular approach.

Biological: Platelet-Rich Plasma (PRP)

Dexamethasone + Local Anaesthetic

ACTIVE COMPARATOR

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.

Drug: Dexamethasone with Local Anaesthetic

Normal Saline (Control)

PLACEBO COMPARATOR

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.

Other: Normal Saline (Placebo)

Interventions

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.

PRP

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.

Dexamethasone + Local Anaesthetic

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.

Normal Saline (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Of Anbar: lead

Study Sites (1)

College of Dentistry, University of Anbar

Ramadi, Al Najaf, 54001, Iraq

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Interventions

Dexamethasone; Anesthesia, Local; Saline Solution

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sabah Alheeti, BDS, CABMS, FIBMS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: "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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Researcher

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: December 10, 2025
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)