TMJ Internal DerangementMRI TMJNCT07750522
Correlation Between MRI Findings and Clinical Improvement Following TMJ Injection With Hyaluronic Acid and Platelet-Rich Plasma
A study testing intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich Plasma in people with TMJ Internal Derangement, run by Mansoura University at 1 site in Egypt.
Trial summary
Temporomandibular joint (TMJ) disorders can cause jaw pain, clicking sounds, and difficulty opening the mouth, affecting daily activities such as eating and speaking. This study aims to determine whether magnetic resonance imaging (MRI) findings can help predict how much patients improve after a single injection into… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- TMJ Internal Derangement
- What is being tested?
- intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich Plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 12 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients age between (18 -45). 2. Early/intermediate stage according to (Wilkes classification). 3. Patients have painful joint, clicking sound, with or without limited mouth opening.
- 4. Patients unresponsive to conservative treatment. 5. Patient's ability and desire to complete the treatment protocol and follow up visits.
- 6. Patients with internal derangement with reduction confirmed by MRI imaging
Who cannot join
- 1. Patient with an inflammatory or connective tissue disease 2. Patient with previous invasive TMJ surgical procedure. 3. neurologic disorders 4. History of injection of any substance into the target TMJ during previous 6 months.
- 5. Patient with history of bony or fibrous adhesion. 6. Internal derangement without reduction. 7. Patient with psychological problem
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
Temporomandibular joint (TMJ) disorders can cause jaw pain, clicking sounds, and difficulty opening the mouth, affecting daily activities such as eating and speaking. This study aims to determine whether magnetic resonance imaging (MRI) findings can help predict how much patients improve after a single injection into the TMJ containing hyaluronic acid and platelet-rich plasma (PRP).
Adults with TMJ internal derangement who have not improved with conservative treatment will receive one injection of hyaluronic acid combined with PRP prepared from their own blood. Participants will be evaluated before treatment and at follow-up visits over 6 months. Assessments will include pain, jaw function, mouth opening, and MRI scans before and after treatment.
The results of this study may improve understanding of the relationship between MRI findings and treatment outcomes and help healthcare providers identify patients who are most likely to benefit from this minimally invasive therapy.
Read the detailed description
Temporomandibular joint (TMJ) internal derangement is one of the most common temporomandibular disorders and is characterized by an abnormal relationship between the articular disc and the mandibular condyle, resulting in pain, joint sounds, and limitation of mandibular movement. Although clinical examination remains the primary diagnostic approach, magnetic resonance imaging (MRI) is considered the gold standard for evaluating TMJ soft tissue structures, including disc position, joint effusion, retrodiscal tissue, and inflammatory changes. However, MRI findings do not always correlate with symptom severity or treatment outcomes, making their prognostic value uncertain.
Intra-articular injection therapy has become a widely accepted minimally invasive treatment for TMJ internal derangement. Hyaluronic acid (HA) improves joint lubrication, reduces inflammation, and provides chondroprotective effects, whereas platelet-rich plasma (PRP) contains autologous growth factors that may enhance tissue repair and regeneration. The combination of HA and PRP may provide both symptomatic relief and biologic enhancement of joint healing.
This randomized controlled clinical trial aims to evaluate the relationship between MRI findings and clinical improvement following a single intra-articular injection of HA combined with PRP in patients with TMJ internal derangement with reduction. Sixty adult patients aged 18-45 years who have persistent symptoms despite conservative treatment and MRI-confirmed internal derangement with reduction will be enrolled.
Before treatment, all participants will undergo a comprehensive clinical examination, including assessment of pain intensity using the Visual Analog Scale (VAS), joint clicking, and maximum interincisal opening (MIO), as well as MRI evaluation of the affected TMJ. Platelet-rich plasma will be prepared from the participant's own blood and mixed with hyaluronic acid for intra-articular injection into the affected joint.
Clinical evaluations will be performed at baseline and at 1 week, 1 month, 3 months, and 6 months after treatment. MRI examinations will be repeated at 6 months. The primary objective is to determine whether baseline MRI findings correlate with and predict clinical improvement after treatment. Secondary objectives include evaluating changes in pain intensity, maximum mouth opening, and joint clicking following HA and PRP injection.
The findings of this study may improve understanding of the relationship between imaging findings and clinical outcomes and assist clinicians in selecting patients who are most likely to benefit from minimally invasive intra-articular injection therapy for TMJ internal derangement.
- Conditions
- TMJ Internal Derangement
- Being tested
- intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich PlasmaProcedure or surgery
Platelet-rich plasma (PRP) will be prepared from 10 mL of the participant's peripheral venous blood using centrifugation. One milliliter of PRP will be mixed with 1 mL of hyaluronic acid and administered as a single intra-articular injection into the affected temporomandibular joint under aseptic conditions. Clinical outcomes (pain intensity, joint clicking, and maximum interincisal opening) will be evaluated at baseline and at 1 week, 1 month, 3 months, and 6 months after treatment. MRI examinations will be performed before treatment and at the 6-month follow-up to assess the relationship between MRI findings and clinical improvement.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Hyaluronic Acid + Platelet-Rich Plasma Injection | Experimental | Participants with MRI-confirmed temporomandibular joint (TMJ) internal derangement with reduction who have failed conservative treatment will receive a single intra-articular injection consisting of 1 mL hyaluronic acid combined with 1 mL autologous platelet-rich plasma (PRP). Participants will be followed for 6 months with clinical assessments and MRI evaluation. Receives: Procedure: intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between baseline MRI findings and clinical improvement
To determine whether baseline magnetic resonance imaging (MRI) findings correlate with and predict clinical improvement following a single intra-articular injection of hyaluronic acid combined with platelet-rich plasma. Clinical improvement will be assessed using pain intensity (Visual Analog Scale), maximum interincisal opening (MIO), and joint clicking. MRI will be repeated at 6 months to evaluate imaging changes.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Apr 2025
- Primary completion12 Apr 2026
- Study completion12 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Internal DerangementStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750522
- Sponsor's protocol ID
- R.26.6.122
- Acronym
- MRI TMJ
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between MRI Findings and Clinical Improvement Following TMJ Injection With Hyaluronic Acid and Platelet-Rich Plasma
- ClinicalTrials.gov ID
- NCT07750522
- Acronym / sponsor ID
- MRI TMJ / R.26.6.122
- Conditions
- TMJ Internal Derangement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 12 Apr 2026 (actual)
- Study completion
- 12 Apr 2026 (actual)
- First posted
- 6 Aug 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.
Temporomandibular joint (TMJ) disorders can cause jaw pain, clicking sounds, and difficulty opening the mouth, affecting daily activities such as eating and speaking. This study aims to determine whether magnetic resonance imaging (MRI) findings can help predict how much patients improve after a single injection into the TMJ containing hyaluronic acid and platelet-rich plasma (PRP).
Adults with TMJ internal derangement who have not improved with conservative treatment will receive one injection of hyaluronic acid combined with PRP prepared from their own blood. Participants will be evaluated before treatment and at follow-up visits over 6 months. Assessments will include pain, jaw function, mouth opening, and MRI scans before and after treatment.
The results of this study may improve understanding of the relationship between MRI findings and treatment outcomes and help healthcare providers identify patients who are most likely to benefit from this minimally invasive therapy.
Detailed description
Temporomandibular joint (TMJ) internal derangement is one of the most common temporomandibular disorders and is characterized by an abnormal relationship between the articular disc and the mandibular condyle, resulting in pain, joint sounds, and limitation of mandibular movement. Although clinical examination remains the primary diagnostic approach, magnetic resonance imaging (MRI) is considered the gold standard for evaluating TMJ soft tissue structures, including disc position, joint effusion, retrodiscal tissue, and inflammatory changes. However, MRI findings do not always correlate with symptom severity or treatment outcomes, making their prognostic value uncertain.
Intra-articular injection therapy has become a widely accepted minimally invasive treatment for TMJ internal derangement. Hyaluronic acid (HA) improves joint lubrication, reduces inflammation, and provides chondroprotective effects, whereas platelet-rich plasma (PRP) contains autologous growth factors that may enhance tissue repair and regeneration. The combination of HA and PRP may provide both symptomatic relief and biologic enhancement of joint healing.
This randomized controlled clinical trial aims to evaluate the relationship between MRI findings and clinical improvement following a single intra-articular injection of HA combined with PRP in patients with TMJ internal derangement with reduction. Sixty adult patients aged 18-45 years who have persistent symptoms despite conservative treatment and MRI-confirmed internal derangement with reduction will be enrolled.
Before treatment, all participants will undergo a comprehensive clinical examination, including assessment of pain intensity using the Visual Analog Scale (VAS), joint clicking, and maximum interincisal opening (MIO), as well as MRI evaluation of the affected TMJ. Platelet-rich plasma will be prepared from the participant's own blood and mixed with hyaluronic acid for intra-articular injection into the affected joint.
Clinical evaluations will be performed at baseline and at 1 week, 1 month, 3 months, and 6 months after treatment. MRI examinations will be repeated at 6 months. The primary objective is to determine whether baseline MRI findings correlate with and predict clinical improvement after treatment. Secondary objectives include evaluating changes in pain intensity, maximum mouth opening, and joint clicking following HA and PRP injection.
The findings of this study may improve understanding of the relationship between imaging findings and clinical outcomes and assist clinicians in selecting patients who are most likely to benefit from minimally invasive intra-articular injection therapy for TMJ internal derangement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Hyaluronic Acid + Platelet-Rich Plasma Injection | Experimental | Procedure: intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich PlasmaParticipants with MRI-confirmed temporomandibular joint (TMJ) internal derangement with reduction who have failed conservative treatment will receive a single intra-articular injection consisting of 1 mL hyaluronic acid combined with 1 mL autologous platelet-rich plasma (PRP). Participants will be followed for 6 months with clinical assessments and MRI evaluation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Patients age between (18 -45). 2. Early/intermediate stage according to (Wilkes classification). 3. Patients have painful joint, clicking sound, with or without limited mouth opening.
- 4. Patients unresponsive to conservative treatment. 5. Patient's ability and desire to complete the treatment protocol and follow up visits.
- 6. Patients with internal derangement with reduction confirmed by MRI imaging
Key exclusion criteria (2 listed)
- 1. Patient with an inflammatory or connective tissue disease 2. Patient with previous invasive TMJ surgical procedure. 3. neurologic disorders 4. History of injection of any substance into the target TMJ during previous 6 months.
- 5. Patient with history of bony or fibrous adhesion. 6. Internal derangement without reduction. 7. Patient with psychological problem
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 |
|---|---|---|
| intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich PlasmaPlatelet-rich plasma (PRP) will be prepared from 10 mL of the participant's peripheral venous blood using centrifugation. One milliliter of PRP will be mixed with 1 mL of hyaluronic acid and administered as a single intra-articular injection into the affected temporomandibular joint under aseptic conditions. Clinical outcomes (pain intensity, joint clicking, and maximum interincisal opening) will be evaluated at baseline and at 1 week, 1 month, 3 months, and 6 months after treatment. MRI examinations will be performed before treatment and at the 6-month follow-up to assess the relationship between MRI findings and clinical improvement. | Procedure or surgery | Experimental: Hyaluronic Acid + Platelet-Rich Plasma Injection |
Primary outcome
Correlation between baseline MRI findings and clinical improvement
Time frame: Baseline to 6 months
To determine whether baseline magnetic resonance imaging (MRI) findings correlate with and predict clinical improvement following a single intra-articular injection of hyaluronic acid combined with platelet-rich plasma. Clinical improvement will be assessed using pain intensity (Visual Analog Scale), maximum interincisal opening (MIO), and joint clicking. MRI will be repeated at 6 months to evaluate imaging changes.
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 6 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-articular Injection of Hyaluronic Acid Combined with Platelet-Rich Plasma in people with TMJ Internal Derangement, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 2 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 6 Aug 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 Egypt. 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. 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?
Correlation between baseline MRI findings and clinical improvement (time frame: Baseline to 6 months). 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 6 Aug 2026.