Temporomandibular Joint Internal DerangementMRINCT07750483
Efficacy of Intra-Articular Hyaluronic Acid Combination Injections for Temporomandibular Joint Internal Derangement: A Clinical and MRI Based Randomized Trial
A study testing intraarticular injection in TMJ in people with Temporomandibular Joint Internal Derangement, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to compare the clinical and magnetic resonance imaging (MRI) outcomes of three intra-articular injection protocols for the treatment of temporomandibular joint (TMJ) internal derangement with reduction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Temporomandibular Joint Internal Derangement
- What is being tested?
- intraarticular injection in TMJ
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 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
- Adults aged 18 to 45 years. TMJ internal derangement with reduction confirmed by MRI. Early or intermediate disease according to Wilkes classification. Painful TMJ with clicking, with or without limited mouth opening. Persistent symptoms despite conservative treatment. Able and willing to provide informed consent and attend follow-up visits.
Who cannot join
- nflammatory or connective tissue disorders. Previous TMJ surgery. Neurological disorders. Previous TMJ injection within the last 6 months. Fibrous or bony ankylosis/adhesion. Internal derangement without reduction. Psychological disorders affecting study participation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
This randomized controlled clinical trial aims to compare the clinical and magnetic resonance imaging (MRI) outcomes of three intra-articular injection protocols for the treatment of temporomandibular joint (TMJ) internal derangement with reduction. Sixty patients who remain symptomatic despite conservative therapy will be randomly assigned to receive hyaluronic acid combined with platelet-rich plasma (PRP), tenoxicam, or corticosteroid. Clinical outcomes including pain intensity, maximum mouth opening, and joint clicking, together with MRI findings, will be evaluated over a 6-month follow-up period.
Read the detailed description
Temporomandibular joint (TMJ) internal derangement is a common disorder associated with pain, joint sounds, and limitation of mandibular function. Although conservative treatment is considered the first-line therapy, some patients continue to experience persistent symptoms requiring minimally invasive intervention.
Hyaluronic acid (HA) is widely used for intra-articular injection because of its lubricating and anti-inflammatory properties. Platelet-rich plasma (PRP) has demonstrated regenerative potential through the release of growth factors that may promote tissue healing. Corticosteroids provide potent anti-inflammatory effects but may adversely affect cartilage with repeated use, whereas tenoxicam is a long-acting nonsteroidal anti-inflammatory drug with favorable analgesic and anti-inflammatory properties.
This prospective randomized controlled clinical trial will compare three treatment protocols:
Hyaluronic acid combined with tenoxicam Hyaluronic acid combined with platelet-rich plasma Hyaluronic acid combined with corticosteroid
Sixty patients diagnosed with TMJ internal derangement with reduction confirmed by MRI and unresponsive to conservative treatment will be randomly allocated in a 1:1:1 ratio to one of the three intervention groups. Clinical assessments will include pain intensity using the Visual Analog Scale (VAS), maximum mouth opening (MMO), and joint clicking at baseline, 1 week, 1 month, 3 months, and 6 months. MRI examinations will be performed at baseline and 6 months to evaluate structural changes within the joint
- Being tested
- intraarticular injection in TMJ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraarticular injection in TMJProcedure or surgery
Hyaluronic Acid + Tenoxicam: Single intra-articular injection of hyaluronic acid combined with tenoxicam administered to the affected temporomandibular joint.
Platelet-Rich Plasma + Hyaluronic Acid: Single intra-articular injection of autologous platelet-rich plasma combined with hyaluronic acid administered to the affected temporomandibular joint.
Hyaluronic Acid + Corticosteroid: Single intra-articular injection of hyaluronic acid combined with corticosteroid administered to the affected temporomandibular joint.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid + Tenoxicam | Experimental | Participants receive a single intra-articular injection of hyaluronic acid combined with tenoxicam into the affected temporomandibular joint. Receives: Procedure: intraarticular injection in TMJ |
| Hyaluronic Acid + Platelet-Rich Plasma (PRP) | Experimental | Single intra-articular injection of hyaluronic acid combined with autologous platelet-rich plasma. Receives: Procedure: intraarticular injection in TMJ |
| hyaluronic acid combined with corticosteroid. | Experimental | Single intra-articular injection of hyaluronic acid combined with corticosteroid. Receives: Procedure: intraarticular injection in TMJ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Clicking
Presence or absence of TMJ clicking will be recorded during mandibular movement.
Measured: Baseline and at 6 months
Change in articular disc position assessed by MRI
Articular disc position was evaluated using closed-mouth MRI at baseline and 24 weeks. Post-treatment changes were classified as no change or worsening, partial disc recapture, or complete disc recapture.
Measured: Baseline and 24 weeks
Secondary outcomes (3)
Change in pain intensity (VAS)
Pain intensity was measured using a 0-10 visual analog scale, with 0 indicating no pain and 10 indicating the worst possible pain.
Measured: Baseline and 1, 4, 12, and 24 weeks
Change in maximum interincisal opening
Maximum interincisal opening was measured in millimeters between the incisal edges of the upper and lower central incisors at maximum mouth opening.
Measured: Baseline and 1, 4, 12, and 24 weeks
Changes in additional MRI findings
MRI assessment included disc morphology, joint effusion, retrodiscal tissue abnormalities, lateral pterygoid muscle status, and osteoarthritic changes, including interval osseous morphological changes
Measured: Baseline and 24 weeks
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 completion1 Mar 2026
- Study completion1 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 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel treatment groups in a 1:1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 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
- NCT07750483
- Sponsor's protocol ID
- R.26.6.121
- Acronym
- MRI
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2026
- Last updated
- 21 Oct 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intra-Articular Hyaluronic Acid Combination Injections for Temporomandibular Joint Internal Derangement: A Clinical and MRI Based Randomized Trial
- ClinicalTrials.gov ID
- NCT07750483
- Acronym / sponsor ID
- MRI / R.26.6.121
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 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.
This randomized controlled clinical trial aims to compare the clinical and magnetic resonance imaging (MRI) outcomes of three intra-articular injection protocols for the treatment of temporomandibular joint (TMJ) internal derangement with reduction. Sixty patients who remain symptomatic despite conservative therapy will be randomly assigned to receive hyaluronic acid combined with platelet-rich plasma (PRP), tenoxicam, or corticosteroid. Clinical outcomes including pain intensity, maximum mouth opening, and joint clicking, together with MRI findings, will be evaluated over a 6-month follow-up period.
Detailed description
Temporomandibular joint (TMJ) internal derangement is a common disorder associated with pain, joint sounds, and limitation of mandibular function. Although conservative treatment is considered the first-line therapy, some patients continue to experience persistent symptoms requiring minimally invasive intervention.
Hyaluronic acid (HA) is widely used for intra-articular injection because of its lubricating and anti-inflammatory properties. Platelet-rich plasma (PRP) has demonstrated regenerative potential through the release of growth factors that may promote tissue healing. Corticosteroids provide potent anti-inflammatory effects but may adversely affect cartilage with repeated use, whereas tenoxicam is a long-acting nonsteroidal anti-inflammatory drug with favorable analgesic and anti-inflammatory properties.
This prospective randomized controlled clinical trial will compare three treatment protocols:
Hyaluronic acid combined with tenoxicam Hyaluronic acid combined with platelet-rich plasma Hyaluronic acid combined with corticosteroid
Sixty patients diagnosed with TMJ internal derangement with reduction confirmed by MRI and unresponsive to conservative treatment will be randomly allocated in a 1:1:1 ratio to one of the three intervention groups. Clinical assessments will include pain intensity using the Visual Analog Scale (VAS), maximum mouth opening (MMO), and joint clicking at baseline, 1 week, 1 month, 3 months, and 6 months. MRI examinations will be performed at baseline and 6 months to evaluate structural changes within the joint
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel treatment groups in a 1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid + Tenoxicam | Experimental | Procedure: intraarticular injection in TMJParticipants receive a single intra-articular injection of hyaluronic acid combined with tenoxicam into the affected temporomandibular joint. |
| Hyaluronic Acid + Platelet-Rich Plasma (PRP) | Experimental | Procedure: intraarticular injection in TMJSingle intra-articular injection of hyaluronic acid combined with autologous platelet-rich plasma. |
| hyaluronic acid combined with corticosteroid. | Experimental | Procedure: intraarticular injection in TMJSingle intra-articular injection of hyaluronic acid combined with corticosteroid. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged 18 to 45 years. TMJ internal derangement with reduction confirmed by MRI. Early or intermediate disease according to Wilkes classification. Painful TMJ with clicking, with or without limited mouth opening. Persistent symptoms despite conservative treatment. Able and willing to provide informed consent and attend follow-up visits.
Key exclusion criteria (1 listed)
- nflammatory or connective tissue disorders. Previous TMJ surgery. Neurological disorders. Previous TMJ injection within the last 6 months. Fibrous or bony ankylosis/adhesion. Internal derangement without reduction. Psychological disorders affecting study participation.
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 |
|---|---|---|
| intraarticular injection in TMJHyaluronic Acid + Tenoxicam: Single intra-articular injection of hyaluronic acid combined with tenoxicam administered to the affected temporomandibular joint. Platelet-Rich Plasma + Hyaluronic Acid: Single intra-articular injection of autologous platelet-rich plasma combined with hyaluronic acid administered to the affected temporomandibular joint. Hyaluronic Acid + Corticosteroid: Single intra-articular injection of hyaluronic acid combined with corticosteroid administered to the affected temporomandibular joint. | Procedure or surgery | Hyaluronic Acid + Platelet-Rich Plasma (PRP), Hyaluronic Acid + Tenoxicam, hyaluronic acid combined with corticosteroid. |
Primary outcome
Joint Clicking
Time frame: Baseline and at 6 months
Presence or absence of TMJ clicking will be recorded during mandibular movement.
Change in articular disc position assessed by MRI
Time frame: Baseline and 24 weeks
Articular disc position was evaluated using closed-mouth MRI at baseline and 24 weeks. Post-treatment changes were classified as no change or worsening, partial disc recapture, or complete disc recapture.
3 secondary outcomes
Change in pain intensity (VAS)
Time frame: Baseline and 1, 4, 12, and 24 weeks
Change in maximum interincisal opening
Time frame: Baseline and 1, 4, 12, and 24 weeks
Changes in additional MRI findings
Time frame: Baseline and 24 weeks
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 21 Oct 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 intraarticular injection in TMJ in people with Temporomandibular Joint 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 1 inclusion and 1 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 21 Oct 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?
Joint Clicking (time frame: Baseline and at 6 months). The study lists 2 primary outcomes in all. 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 21 Oct 2026.