TMJ Disc Displacement With ReductionNCT07535073
Ultrasound-guided Versus Arthroscopic Guided PRF Injection for TMJ Disc Displacement.
A study testing ultrasound guided platelet rich fibrin injection and Arthroscopic guided platelet rich Fibrin injection in people with TMJ Disc Displacement With Reduction, run by Cairo University.
Trial summary
To compare the clinical effectiveness of ultrasound-guided versus arthroscopic guided platelet rich fibrin injection in the management of anterior disc displacement with reduction of the temporomandibular joint, in terms of pain reduction, improvement of mandibular function, and patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- TMJ Disc Displacement With Reduction
- What is being tested?
- ultrasound guided platelet rich fibrin injection and Arthroscopic guided platelet rich Fibrin injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2026to 7 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-60 years.
- Clinically and radiographically diagnosed temporomandibular joint disc displacemet with reduction.
- Presence of TMJ pain exacerbated by mandibular movement.
- Limited mandibular function and/or reduced maximum mouth opening.
- Symptoms persisting for at least 3 months.
- Failure of conservative treatment (e.g. occlusal splint, physiotherapy, NSAIDs). -Ability to understand the study protocol and provide informed consent.
Who cannot join
- Previous TMJ surgery or arthroscopic intervention.
- Intra-articular injection in the TMJ within the last 6 months.
- Systemic inflammatory or autoimmune joint diseases.
- Coagulation disorders or current anticoagulant therapy.
- Active local infection at the injection site.
- Pregnancy or lactation.
- Severe degenerative joint disease (advanced osteoarthritis).
- Known allergy or contraindication to ( PRF) preparation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound Guided Versus Arthroscopic Guided PRF Injection in Management of Temporomandibular Joint Disc Displacement With Reduction: A Randomized Controlled Clinical Trials
To compare the clinical effectiveness of ultrasound-guided versus arthroscopic guided platelet rich fibrin injection in the management of anterior disc displacement with reduction of the temporomandibular joint, in terms of pain reduction, improvement of mandibular function, and patient-reported outcomes.
Read the detailed description
Internal derangements of the temporomandibular joint, particularly disc displacement with reduction, represent a significant proportion of temporomandibular disorders. Conventional conservative treatments may not always achieve satisfactory symptom resolution, leading to increased interest in minimally invasive interventions. PRF has gained attention for its ability to promote tissue regeneration, reduce inflammation, and enhance healing through the sustained release of growth factors. Image-guided injection techniques are essential for ensuring accurate delivery of PRF into the targeted joint structures. Arthroscopic-guided injection allows direct visualization of intra-articular anatomy but is invasive, technically demanding, and associated with higher cost and procedural complexity. In contrast, ultrasound-guided injection is a non-invasive, radiation-free, and cost- effective technique that enables real-time visualization of soft tissues and needle placement. Despite these advantages, the comparative clinical efficacy of ultrasound-guided versus arthroscopic-guided PRF injection remains inadequately explored, particularly in patients with TMJ disc displacement with reduction.
- Conditions
- TMJ Disc Displacement With Reduction
- Being tested
- ultrasound guided platelet rich fibrin injection, Arthroscopic guided platelet rich Fibrin injection
- Keywords
- temporomandibular joint, Tmj disc displacement, PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided platelet rich fibrin injectionDevice
- A high-frequency linear ultrasound probe will be used to identify the TMJ space.
- A sterile syringe containing 1 mL of PRF will be inserted into the superior joint space under real-time ultrasound guidance.
- PRF will be injected slowly with continuous confirmation of needle position.
Arthroscopic guided platelet rich Fibrin injectionDevice
- TMJ arthroscopy will be performed under local or general anesthesia following standard aseptic preparation.
- The superior joint space will be visualized using a 1.9 mm arthroscope.
- A sterile syringe containing 1 mL of PRF will be introduced through a lateral portal under direct arthroscopic visualization.
- PRF will be injected slowly into the superior joint space.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided platelet rich fibrin injection. | Experimental | Patient receive PRF injection under ultrasound guidance Receives: Device: ultrasound guided platelet rich fibrin injection |
| Arthroscopic guided platelet-rich fibrin injection. | Experimental | Patient receive PRF injection under arsothscopic guidance Receives: Device: Arthroscopic guided platelet rich Fibrin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum mouth opening
Maximum interincisal distance measured using digital caliper in millimeters (mm) between upper and lower central incisors, Unit of measure: millimeters (mm). Minimum value: 0 mm. Maximum value: 60 mm. Higher values represent a better outcome.
Measured: 6 months
Secondary outcomes (1)
Pain intensity
Pain intensity assessed using 100 mm Visual Analog Scale (VAS). 0 = no pain; 10 = worst pain imaginable. Unit of measure: points (0-10). Minimum value: 0. Maximum value: 10. Higher scores represent a worse outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start7 May 2026 (estimated)
- Primary completion7 Feb 2027 (estimated)
- Study completion7 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TMJ Disc Displacement With ReductionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami faiz kahwaji, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535073
- Sponsor's protocol ID
- OMFS-TMJ-PRF-RCT01
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan at this time due to data sensitivity, ongoing sponsor review, and lack of established infrastructure.
Publications
Gonzalez LV, Lopez JP, Diaz-Baez D, Orjuela MP, Chavez M. Clinical outcomes of operative arthroscopy and temporomandibular medical infiltration with platelet-rich fibrin in upper and lower articular space. J Craniomaxillofac Surg. 2021 Dec;49(12):1162-1168. doi: 10.1016/j.jcms.2021.07.001. Epub 2021 Aug 3.
PubMed 34384651Chaudhary FA, Ahmad B, Butt DQ, Hameed S, Bashir U. Normal range of maximum mouth opening in Pakistani population: A cross-sectional study. J Int Oral Health. 2019;11(6):353-356. doi:10.4103/jioh.jioh_127_19.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Versus Arthroscopic Guided PRF Injection in Management of Temporomandibular Joint Disc Displacement With Reduction: A Randomized Controlled Clinical Trials
- ClinicalTrials.gov ID
- NCT07535073
- Acronym / sponsor ID
- OMFS-TMJ-PRF-RCT01
- Conditions
- TMJ Disc Displacement With Reduction
- Keywords
- temporomandibular joint, Tmj disc displacement, PRF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 May 2026 (estimated)
- Primary completion
- 7 Feb 2027 (estimated)
- Study completion
- 7 Jun 2027 (estimated)
- First posted
- 16 Apr 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.
To compare the clinical effectiveness of ultrasound-guided versus arthroscopic guided platelet rich fibrin injection in the management of anterior disc displacement with reduction of the temporomandibular joint, in terms of pain reduction, improvement of mandibular function, and patient-reported outcomes.
Detailed description
Internal derangements of the temporomandibular joint, particularly disc displacement with reduction, represent a significant proportion of temporomandibular disorders. Conventional conservative treatments may not always achieve satisfactory symptom resolution, leading to increased interest in minimally invasive interventions. PRF has gained attention for its ability to promote tissue regeneration, reduce inflammation, and enhance healing through the sustained release of growth factors. Image-guided injection techniques are essential for ensuring accurate delivery of PRF into the targeted joint structures. Arthroscopic-guided injection allows direct visualization of intra-articular anatomy but is invasive, technically demanding, and associated with higher cost and procedural complexity. In contrast, ultrasound-guided injection is a non-invasive, radiation-free, and cost- effective technique that enables real-time visualization of soft tissues and needle placement. Despite these advantages, the comparative clinical efficacy of ultrasound-guided versus arthroscopic-guided PRF injection remains inadequately explored, particularly in patients with TMJ disc displacement with reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided platelet rich fibrin injection. | Experimental | Device: ultrasound guided platelet rich fibrin injectionPatient receive PRF injection under ultrasound guidance |
| Arthroscopic guided platelet-rich fibrin injection. | Experimental | Device: Arthroscopic guided platelet rich Fibrin injectionPatient receive PRF injection under arsothscopic guidance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18-60 years.
- Clinically and radiographically diagnosed temporomandibular joint disc displacemet with reduction.
- Presence of TMJ pain exacerbated by mandibular movement.
- Limited mandibular function and/or reduced maximum mouth opening.
- Symptoms persisting for at least 3 months.
Key exclusion criteria (8 listed)
- Previous TMJ surgery or arthroscopic intervention.
- Intra-articular injection in the TMJ within the last 6 months.
- Systemic inflammatory or autoimmune joint diseases.
- Coagulation disorders or current anticoagulant therapy.
- Active local infection at the injection site.
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 |
|---|---|---|
| ultrasound guided platelet rich fibrin injection1. A high-frequency linear ultrasound probe will be used to identify the TMJ space. 2. A sterile syringe containing 1 mL of PRF will be inserted into the superior joint space under real-time ultrasound guidance. 3. PRF will be injected slowly with continuous confirmation of needle position. | Device | Ultrasound guided platelet rich fibrin injection. |
| Arthroscopic guided platelet rich Fibrin injection1. TMJ arthroscopy will be performed under local or general anesthesia following standard aseptic preparation. 2. The superior joint space will be visualized using a 1.9 mm arthroscope. 3. A sterile syringe containing 1 mL of PRF will be introduced through a lateral portal under direct arthroscopic visualization. 4. PRF will be injected slowly into the superior joint space. | Device | Arthroscopic guided platelet-rich fibrin injection. |
Primary outcome
Maximum mouth opening
Time frame: 6 months
Maximum interincisal distance measured using digital caliper in millimeters (mm) between upper and lower central incisors, Unit of measure: millimeters (mm). Minimum value: 0 mm. Maximum value: 60 mm. Higher values represent a better outcome.
1 secondary outcome
Pain intensity
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 34384651Gonzalez LV, Lopez JP, Diaz-Baez D, Orjuela MP, Chavez M. Clinical outcomes of operative arthroscopy and temporomandibular medical infiltration with platelet-rich fibrin in upper and lower articular space. J Craniomaxillofac Surg. 2021 Dec;49(12):1162-1168. doi: 10.1016/j.jcms.2021.07.001. Epub 2021 Aug 3.
- BackgroundChaudhary FA, Ahmad B, Butt DQ, Hameed S, Bashir U. Normal range of maximum mouth opening in Pakistani population: A cross-sectional study. J Int Oral Health. 2019;11(6):353-356. doi:10.4103/jioh.jioh_127_19.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No IPD sharing plan at this time due to data sensitivity, ongoing sponsor review, and lack of established infrastructure.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided platelet rich fibrin injection and Arthroscopic guided platelet rich Fibrin injection in people with TMJ Disc Displacement With Reduction, run by Cairo University.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sami Faiz Kahwaji, DDS (+20 1096094940, sami.kahwaji@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum mouth opening (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07535073, which also lists 2 linked publications.
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 16 Apr 2026.