Anterior Disk Displacement TMJRCTNCT07266714
Ultrasound-guided vs Conventional Intraarticular Injection of Hyaluronic Acid for Management of Temporomandibular Joint Internal Derangement
A study testing Ultrasound guided injection with hyaluronic acid and Conventional in people with Anterior Disk Displacement TMJ, run by Muhannad at 1 site in Egypt.
Trial summary
The aim of the study will be to evaluate the clinical efficacy of using ultrasound guidance during intra-articular injection of hyaluronic acid in the management of patients with TMJ internal derangement. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Disk Displacement TMJ
- What is being tested?
- Ultrasound guided injection with hyaluronic acid and Conventional
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Sep 2025
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients that will be diagnosed disc displacement confirmed clinically and by Magnetic Resonance Imaging (MRI).
- Patient not responding to conservative therapy
- Patients age must be (18 - 50).
- Patients having painful joint, clicking sound, with or without limited mouth opening.
- Patient's ability and desire to complete the treatment protocol and follow-up visits.
Who cannot join
- Patient with an inflammatory or connective tissue disease
- Patient with previous invasive TMJ surgical procedure.
- Patient with Neurologic disorders
- History of injection of any substance into the target TMJ during previous 6 months.
- Patient with a history of bony adhesion.
- Malignant disease in the head and neck region.
- Patient with a psychological problem.
- Patients having gross mechanical restrictions and condylar fracture
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study will be to evaluate the clinical efficacy of using ultrasound guidance during intra-articular injection of hyaluronic acid in the management of patients with TMJ internal derangement.
Read the detailed description
The temporomandibular joint (TMJ) represents one of the most biomechanically sophisticated and functionally critical articulations in the human body, serving as the primary interface between the mandible and the cranium.
This synovial joint facilitates essential orofacial functions including mastication, phonation, deglutition, and emotional expression through its unique ginglymoarthrodial (hinge-gliding) motion.
Temporomandibular disorders (TMDs) constitute a major public health burden, with epidemiological studies reporting prevalence rates ranging from 5% to 12% in global populations, though subclinical manifestations may affect up to 40% of adults.
The socioeconomic impact is substantial, with chronic TMD patients demonstrating significantly reduced quality-of-life indices comparable to conditions like rheumatoid arthritis, primarily due to persistent pain, functional limitations, and comorbidities with tension-type headaches and sleep disturbances.
Historically, TMJ research evolved from purely mechanical models to contemporary biopsychosocial paradigms that acknowledge multifactorial etiology.
Modern diagnostic frameworks, notably the Diagnostic Criteria for TMD (DC/TMD), emphasize the interplay between articular pathophysiology (e.g., disc displacement, osteoarthritis) and psychosocial dimensions (e.g., catastrophizing, depression), necessitating interdisciplinary management strategies.
Advances in molecular biology have elucidated genetic predispositions (e.g., COMT gene polymorphisms) and inflammatory cascades (IL-1β, TNF-α) that modulate pain sensitization and tissue degeneration.
Concurrently, innovations in diagnostic imaging-particularly dynamic MRI and cone-beam computed tomography (CBCT)-have revolutionized the evaluation of joint kinematics and microarchitecture, enabling earlier detection of degenerative changes.
The clinical management landscape continues to evolve toward minimally invasive biotherapies (e.g., platelet-rich plasma injections) and personalized rehabilitation protocols, though significant challenges persist in predicting treatment responsiveness.
Future research imperatives include validating biomarkers for early TMD detection, optimizing tissue-engineering approaches for condylar regeneration, and integrating artificial intelligence for phenotyping heterogeneous patient subgroups.
- Conditions
- Anterior Disk Displacement TMJ
- Being tested
- Ultrasound guided injection with hyaluronic acid, Conventional
- Keywords
- Temporomandibular Joint, Disc displacement with reduction, Ultrasound, Hyaluronic acid.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided injection with hyaluronic acidDevice
Ultrtasound Guided injection of Hyaluronic Acid
ConventionalOther
Conventional injection of hyaluronic Acid
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided itra-articular injection of hyaluronic acid | Experimental | Not described Receives: Device: Ultrasound guided injection with hyaluronic acid |
| Conventional intra-articular injection of hyaluronic acid | Experimental | Not described Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Visual Analogue Scale)
Pain intensity will be assessed by visual analog scale (VAS) score. Zero score for no pain and 10 score for worst pain experienced
Measured: preoperative and postoerative after 1 week, 3 month and 6 month
Clicking sound
Clicking sound will be assessed as to its presence = 1 or absence = 0.
Measured: preoperative and postoerative after 1 week, 3 month and 6 month
Maximum inter-incisal opening (MIO)
will be measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.
Measured: preoperative and postoerative after 1 week, 3 month and 6 month
Range of lateral mandibular excursions
will be masseured by Vernier caliper as the horizontal distance in millimeter from maxillary mid line to mandibular mid line with the patient first moving the mandible to one side than to the other at the maximum extend
Measured: preoperative and postoerative after 1 week, 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Sep 2024
- Primary completion30 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Disk Displacement TMJStudies 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, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhannad
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor-investigator, Muhannad, Mansoura University
- Investigators
- Sally Elsayed Abdelsameaa, Assistant Professor, Principal investigator, Mansoura UniversityMuhammad Adel Al-Hawari, Lecturer, Principal investigator, Mansoura UniversityAyman Ahmed Yaseen, Lecturer, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266714
- Sponsor's protocol ID
- A0109024OS
- Acronym
- RCT
- Status last verified
- Sep 2025
- First submitted
- 24 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided vs Conventional Intraarticular Injection of Hyaluronic Acid for Management of Temporomandibular Joint Internal Derangement
- ClinicalTrials.gov ID
- NCT07266714
- Acronym / sponsor ID
- RCT / A0109024OS
- Conditions
- Anterior Disk Displacement TMJ
- Keywords
- Temporomandibular Joint, Disc displacement with reduction, Ultrasound, Hyaluronic acid.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MuhannadUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 5 Dec 2025 (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.
The aim of the study will be to evaluate the clinical efficacy of using ultrasound guidance during intra-articular injection of hyaluronic acid in the management of patients with TMJ internal derangement.
Detailed description
The temporomandibular joint (TMJ) represents one of the most biomechanically sophisticated and functionally critical articulations in the human body, serving as the primary interface between the mandible and the cranium.
This synovial joint facilitates essential orofacial functions including mastication, phonation, deglutition, and emotional expression through its unique ginglymoarthrodial (hinge-gliding) motion.
Temporomandibular disorders (TMDs) constitute a major public health burden, with epidemiological studies reporting prevalence rates ranging from 5% to 12% in global populations, though subclinical manifestations may affect up to 40% of adults.
The socioeconomic impact is substantial, with chronic TMD patients demonstrating significantly reduced quality-of-life indices comparable to conditions like rheumatoid arthritis, primarily due to persistent pain, functional limitations, and comorbidities with tension-type headaches and sleep disturbances.
Historically, TMJ research evolved from purely mechanical models to contemporary biopsychosocial paradigms that acknowledge multifactorial etiology.
Modern diagnostic frameworks, notably the Diagnostic Criteria for TMD (DC/TMD), emphasize the interplay between articular pathophysiology (e.g., disc displacement, osteoarthritis) and psychosocial dimensions (e.g., catastrophizing, depression), necessitating interdisciplinary management strategies.
Advances in molecular biology have elucidated genetic predispositions (e.g., COMT gene polymorphisms) and inflammatory cascades (IL-1β, TNF-α) that modulate pain sensitization and tissue degeneration.
Concurrently, innovations in diagnostic imaging-particularly dynamic MRI and cone-beam computed tomography (CBCT)-have revolutionized the evaluation of joint kinematics and microarchitecture, enabling earlier detection of degenerative changes.
The clinical management landscape continues to evolve toward minimally invasive biotherapies (e.g., platelet-rich plasma injections) and personalized rehabilitation protocols, though significant challenges persist in predicting treatment responsiveness.
Future research imperatives include validating biomarkers for early TMD detection, optimizing tissue-engineering approaches for condylar regeneration, and integrating artificial intelligence for phenotyping heterogeneous patient subgroups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided itra-articular injection of hyaluronic acid | Experimental | Device: Ultrasound guided injection with hyaluronic acid |
| Conventional intra-articular injection of hyaluronic acid | Experimental | Other: Conventional |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients that will be diagnosed disc displacement confirmed clinically and by Magnetic Resonance Imaging (MRI).
- Patient not responding to conservative therapy
- Patients age must be (18 - 50).
- Patients having painful joint, clicking sound, with or without limited mouth opening.
- Patient's ability and desire to complete the treatment protocol and follow-up visits.
Key exclusion criteria (8 listed)
- Patient with an inflammatory or connective tissue disease
- Patient with previous invasive TMJ surgical procedure.
- Patient with Neurologic disorders
- History of injection of any substance into the target TMJ during previous 6 months.
- Patient with a history of bony adhesion.
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 injection with hyaluronic acidUltrtasound Guided injection of Hyaluronic Acid | Device | Ultrasound guided itra-articular injection of hyaluronic acid |
| ConventionalConventional injection of hyaluronic Acid | Other | Conventional intra-articular injection of hyaluronic acid |
Primary outcome
Pain (Visual Analogue Scale)
Time frame: preoperative and postoerative after 1 week, 3 month and 6 month
Pain intensity will be assessed by visual analog scale (VAS) score. Zero score for no pain and 10 score for worst pain experienced
Clicking sound
Time frame: preoperative and postoerative after 1 week, 3 month and 6 month
Clicking sound will be assessed as to its presence = 1 or absence = 0.
Maximum inter-incisal opening (MIO)
Time frame: preoperative and postoerative after 1 week, 3 month and 6 month
will be measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.
Range of lateral mandibular excursions
Time frame: preoperative and postoerative after 1 week, 3 month and 6 month
will be masseured by Vernier caliper as the horizontal distance in millimeter from maxillary mid line to mandibular mid line with the patient first moving the mandible to one side than to the other at the maximum extend
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 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Disk Displacement TMJ
Recruiting
Calcium Gluconate Activated in Anterior Disc Displacement With Reduction of the Temporomandibular Joint
Temporomandibular Joint Disorders
Active, not recruitingPhase 2
Assessment of Injectable PRF Versus Dextrose Injection in Temporomandibular Joint in Anterior Disc Displacement With Reduction
TMD
Recruiting
Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint
Not yet recruiting
Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ
Not yet recruiting
Arthroscopic Lysis and Lavage With and Without Intra-articular Injection of Hyaluronic Acid in Patients With DDwoR in TMJ
TMJ Disc Disorder, Temporomandibular Joint Disc Displacement, Without Reduction
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.
Sally Elsayed Abdelsameaa, Assistant Professor principal investigator
Mansoura University
Muhammad Adel Al-Hawari, Lecturer principal investigator
Mansoura University
Ayman Ahmed Yaseen, Lecturer principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided injection with hyaluronic acid and Conventional in people with Anterior Disk Displacement TMJ, run by Muhannad 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 5 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: finished, as of the sponsor's last update on 5 Dec 2025. 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?
Pain (Visual Analogue Scale) (time frame: preoperative and postoerative after 1 week, 3 month and 6 month). The study lists 4 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 5 Dec 2025.