Temporomandibular Joint DisordersNCT07691684
Intra-Articular PRP Versus Dexamethasone for TMJ Internal Derangement
A study testing Platelet-Rich Plasma (PRP) and Dexamethasone with Local Anaesthetic in people with Temporomandibular Joint Disorders and Temporomandibular Joint Internal Derangement, run by University Of Anbar at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Joint Internal Derangement, Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Platelet-Rich Plasma (PRP) and Dexamethasone with Local Anaesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 10 Dec 2025to 9 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Intra-articular injection within the previous six months
- Systemic inflammatory arthropathy
- Coagulopathy
- Active local infection
- Low platelet count
- Ongoing antiplatelet or anticoagulant therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Joint Internal Derangement, Temporomandibular Joint Dysfunction Syndrome
- Being tested
- Platelet-Rich Plasma (PRP), Dexamethasone with Local Anaesthetic, Normal Saline (Placebo)
- Keywords
- Dexamethasone, Platelet-Rich Plasma, Intra-articular Injection, TMJ, Randomized Controlled Trial
- Medical subject headings
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 AnaestheticDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 week post-injection
Secondary outcomes (2)
Change in Joint Sound (Clicking)
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.
Measured: Baseline and 1 week post-injection
Change in Maximum Interincisal Opening (MIO)
Maximum interincisal opening measured in millimetres between upper and lower central incisors at maximum voluntary mouth opening.
Measured: Baseline and 1 week post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start10 Dec 2025
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Anbar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Salam Abdulraheem Twayej, University Of Anbar
- Investigators
- Sabah Alheeti, BDS, CABMS, FIBMS, Principal investigator, Oral and Maxillofacial Surgery Department / College of Dentistry / University of Anbar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691684
- Sponsor's protocol ID
- UoAnbar-TMJ-PRP-2025
- Other IDs
- 141
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "The dataset supporting the conclusions of this article may be requested from the corresponding author"
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07691684
- Acronym / sponsor ID
- UoAnbar-TMJ-PRP-2025
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Joint Internal Derangement, Temporomandibular Joint Dysfunction Syndrome
- Keywords
- Dexamethasone, Platelet-Rich Plasma, Intra-articular Injection, TMJ, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Of AnbarUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Biological: Platelet-Rich Plasma (PRP)Single intra-articular injection of 0.6 mL leukocyte-poor platelet-rich plasma (PRP) into the superior joint space via a preauricular approach. |
| Dexamethasone + Local Anaesthetic | Active comparator | Drug: Dexamethasone with Local AnaestheticSingle 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. |
| Normal Saline (Control) | Placebo comparator | Other: Normal Saline (Placebo)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Intra-articular injection within the previous six months
- Systemic inflammatory arthropathy
- Coagulopathy
- Active local infection
- Low platelet count
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | PRP |
| Dexamethasone with Local AnaestheticIntra-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. | Drug | Dexamethasone + Local Anaesthetic |
| 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. | Other | Normal Saline (Control) |
Primary outcome
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.
2 secondary outcomes
Change in Joint Sound (Clicking)
Time frame: Baseline and 1 week post-injection
Change in Maximum Interincisal Opening (MIO)
Time frame: Baseline and 1 week post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. "The dataset supporting the conclusions of this article may be requested from the corresponding author"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabah Alheeti, BDS, CABMS, FIBMS principal investigator
Oral and Maxillofacial Surgery Department / College of Dentistry / University of Anbar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Plasma (PRP) and Dexamethasone with Local Anaesthetic in people with Temporomandibular Joint Disorders and Temporomandibular Joint Internal Derangement, run by University Of Anbar at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (VAS) (time frame: Baseline and 1 week post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.