- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07691684
Intra-Articular PRP Versus Dexamethasone for TMJ Internal Derangement
July 2, 2026 updated by: 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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Al Najaf
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Ramadi, Al Najaf, Iraq, 54001
- College of Dentistry, University of Anbar
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRP
Single intra-articular injection of 0.6 mL leukocyte-poor platelet-rich plasma (PRP) into the superior joint space via a preauricular approach.
|
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.
|
|
Active Comparator: 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.
|
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 Comparator: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 1 week post-injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 1 week post-injection
|
|
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.
|
Baseline and 1 week post-injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sabah Alheeti, BDS, CABMS, FIBMS, Oral and Maxillofacial Surgery Department / College of Dentistry / University of Anbar
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2025
Primary Completion (Actual)
April 9, 2026
Study Completion (Actual)
April 9, 2026
Study Registration Dates
First Submitted
July 2, 2026
First Submitted That Met QC Criteria
July 2, 2026
First Posted (Actual)
July 9, 2026
Study Record Updates
Last Update Posted (Actual)
July 9, 2026
Last Update Submitted That Met QC Criteria
July 2, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Muscular Diseases
- Joint Diseases
- Jaw Diseases
- Mandibular Diseases
- Craniomandibular Disorders
- Myofascial Pain Syndromes
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Pharmaceutical Preparations
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Crystalloid Solutions
- Isotonic Solutions
- Solutions
- Anesthesia and Analgesia
- Pregnadienetriols
- Anesthesia, Conduction
- Anesthesia
- Dexamethasone
- Saline Solution
- Anesthesia, Local
Other Study ID Numbers
- UoAnbar-TMJ-PRP-2025
- 141 (Other Identifier: University of Anbar Ethical Approval Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
"The dataset supporting the conclusions of this article may be requested from the corresponding author"
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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