Internal Derangement of the Tempromandibular JointNCT06657118
Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement.
A study testing Ultrasound guided arthrocentesis of tempromandibular joint and Conventional anatomically guided arthrocentesis of tempromandibular joint in people with Internal Derangement of the Tempromandibular Joint, run by Samiha Abdelsalam Abdelaziz Abdelaziz.
Trial summary
The use of Ultrasound as a guide in arthrocentesis of tempromandibular joint versus conventional anatomically guided arthrocentesis in treatment of temporomandibular joint internal derangement: A randomized clinical trial. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Internal Derangement of the Tempromandibular Joint
- What is being tested?
- Ultrasound guided arthrocentesis of tempromandibular joint and Conventional anatomically guided arthrocentesis of tempromandibular joint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Nov 2026
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patients aged 16 to 45 years of age having temporomandibular joint internal derangement.
- Patients free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- ASA 1-2 patients with no contraindications for GA
- Patients who did not respond to conservative treatment.
Who cannot join
- Patient with uncontrolled systemic diseases precluding administration of general anesthesia.
- Handicaps and special needs patients.
- Prisoners.
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 Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial
The use of Ultrasound as a guide in arthrocentesis of tempromandibular joint versus conventional anatomically guided arthrocentesis in treatment of temporomandibular joint internal derangement: A randomized clinical trial.
- Being tested
- Ultrasound guided arthrocentesis of tempromandibular joint, Conventional anatomically guided arthrocentesis of tempromandibular joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided arthrocentesis of tempromandibular jointProcedure or surgery
- Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
- Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug.
- Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained.
- Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines.
- Superior joint space located between the disc and articular eminence is the targeted point of the needle.
Intra-operative procedures - continued in both groups:
- Lavage is performed with 100 ml of saline solution.
- 1 ml of Hyaluronic acid is injected into the superior joint space.
- Puncture point is covered with sterile dressing for 24 hours
Conventional anatomically guided arthrocentesis of tempromandibular jointProcedure or surgery
- Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
- Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug.
- A line will be drawn from tragus of the ear to the outer canthus of the eye with ink.
- Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line.
Intra-operative procedures - continued in both groups:
- Lavage is performed with 100 ml of saline solution.
- 1 ml of Hyaluronic acid is injected into the superior joint space.
- Puncture point is covered with sterile dressing for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Conventional arthrocentesis | Active comparator | * Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
* Head turned to the affected side.
* External auditory meatus will be blocked with a cotton plug.
* A line will be drawn from tragus of the ear to the outer canthus of the eye with ink.
* Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line.
Intra-operative procedures - continued in both groups:
* Lavage is performed with 100 ml of saline solution.
* 1 ml of Hyaluronic acid is injected into the superior joint space.
* Puncture point is covered with sterile dressing for 24 hours Receives: Procedure: Conventional anatomically guided arthrocentesis of tempromandibular joint |
| Ultrasound guided arthrocentesis | Active comparator | Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
* Head turned to the affected side.
* External auditory meatus will be blocked with a cotton plug.
* Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained.
* Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines.
* Superior joint space located between the disc and articular eminence is the targeted point of the needle.
Intra-operative procedures - continued in both groups:
* Lavage is performed with 100 ml of saline solution.
* 1 ml of Hyaluronic acid is injected into the superior joint space.
* Puncture point is covered with sterile dressing for 24 hours Receives: Procedure: Ultrasound guided arthrocentesis of tempromandibular joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum mouth opening
Maximum mouth opening of the patient will be measured in Millimetre (mm) using a ruler
Measured: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Joint pain
Joint pain: Will be measured by visual analogue scale (VAS) of 10 units according to pre-determined reference values: 0 No pain. 1-2 Faint pain. 3-4 Mild pain 5-6 Moderate pain. 7-8 Severe pain. 9-10 Excruciating pain.
Measured: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Secondary outcomes (1)
Operation time
Operation time will be measured using stopwatch and recorded in minutes
Measured: Once during every procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study startOct 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Internal Derangement of the Tempromandibular JointStudies 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
- Model description
- A randomized control trial, parallel group, allocation ratio 1:1 Framework equivalence
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samiha Abdelsalam Abdelaziz Abdelaziz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samiha Abdelsalam Abdelaziz Abdelaziz, Cairo University
- Investigators
- Gamal Moutaed, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657118
- Sponsor's protocol ID
- US guided arthrocentesis
- Status last verified
- Aug 2025
- First submitted
- 23 Oct 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share it with other researchers websites if it is possible
Publications
Dong XY, He S, Zhu L, Dong TY, Pan SS, Tang LJ, Zhu ZF. The diagnostic value of high-resolution ultrasonography for the detection of anterior disc displacement of the temporomandibular joint: a meta-analysis employing the HSROC statistical model. Int J Oral Maxillofac Surg. 2015 Jul;44(7):852-8. doi: 10.1016/j.ijom.2015.01.012. Epub 2015 Feb 20.
PubMed 25702588Maranini B, Ciancio G, Mandrioli S, Galie M, Govoni M. The Role of Ultrasound in Temporomandibular Joint Disorders: An Update and Future Perspectives. Front Med (Lausanne). 2022 Jun 20;9:926573. doi: 10.3389/fmed.2022.926573. eCollection 2022.
PubMed 35795636Poveda Roda R, Diaz Fernandez JM, Hernandez Bazan S, Jimenez Soriano Y, Margaix M, Sarrion G. A review of temporomandibular joint disease (TMJD). Part II: Clinical and radiological semiology. Morbidity processes. Med Oral Patol Oral Cir Bucal. 2008 Feb 1;13(2):E102-9.
PubMed 18223525Champs B, Corre P, Hamel A, Laffite CD, Le Goff B. US-guided temporomandibular joint injection: Validation of an in-plane longitudinal approach. J Stomatol Oral Maxillofac Surg. 2019 Feb;120(1):67-70. doi: 10.1016/j.jormas.2018.10.008. Epub 2018 Nov 6.
PubMed 30412740Bhargava D, Thomas S, Pawar P, Jain M, Pathak P. Ultrasound-guided arthrocentesis using single-puncture, double-lumen, single-barrel needle for patients with temporomandibular joint acute closed lock internal derangement. Oral Maxillofac Surg. 2019 Jun;23(2):159-165. doi: 10.1007/s10006-019-00753-6. Epub 2019 Mar 28.
PubMed 30923970Azlag Pekince K, Caglayan F, Pekince A. The efficacy and limitations of USI for diagnosing TMJ internal derangements. Oral Radiol. 2020 Jan;36(1):32-39. doi: 10.1007/s11282-019-00376-3. Epub 2019 Feb 4.
PubMed 30719601
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06657118
- Acronym / sponsor ID
- US guided arthrocentesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Samiha Abdelsalam Abdelaziz AbdelazizUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Oct 2024 (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 use of Ultrasound as a guide in arthrocentesis of tempromandibular joint versus conventional anatomically guided arthrocentesis in treatment of temporomandibular joint internal derangement: A randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized control trial, parallel group, allocation ratio 1:1 Framework equivalence
| Arm | Type | Receives |
|---|---|---|
| Conventional arthrocentesis | Active comparator | Procedure: Conventional anatomically guided arthrocentesis of tempromandibular joint* Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub. * Head turned to the affected side. * External auditory meatus will be blocked with a cotton plug. * A line will be drawn from tragus of the ear to the outer canthus of the eye with ink. * Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line. Intra-operative procedures - continued in both groups: * Lavage is performed with 100 ml of saline solution. * 1 ml of Hyaluronic acid is injected into the superior joint space. * Puncture point is covered with sterile dressing for 24 hours |
| Ultrasound guided arthrocentesis | Active comparator | Procedure: Ultrasound guided arthrocentesis of tempromandibular jointScrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub. * Head turned to the affected side. * External auditory meatus will be blocked with a cotton plug. * Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained. * Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines. * Superior joint space located between the disc and articular eminence is the targeted point of the needle. Intra-operative procedures - continued in both groups: * Lavage is performed with 100 ml of saline solution. * 1 ml of Hyaluronic acid is injected into the superior joint space. * Puncture point is covered with sterile dressing for 24 hours |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adult patients aged 16 to 45 years of age having temporomandibular joint internal derangement.
- Patients free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- ASA 1-2 patients with no contraindications for GA
- Patients who did not respond to conservative treatment.
Key exclusion criteria (3 listed)
- Patient with uncontrolled systemic diseases precluding administration of general anesthesia.
- Handicaps and special needs patients.
- Prisoners.
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 arthrocentesis of tempromandibular joint* Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub. * Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug. * Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained. * Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines. * Superior joint space located between the disc and articular eminence is the targeted point of the needle. Intra-operative procedures - continued in both groups: * Lavage is performed with 100 ml of saline solution. * 1 ml of Hyaluronic acid is injected into the superior joint space. * Puncture point is covered with sterile dressing for 24 hours | Procedure or surgery | Ultrasound guided arthrocentesis |
| Conventional anatomically guided arthrocentesis of tempromandibular joint* Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub. * Head turned to the affected side. • External auditory meatus will be blocked with a cotton plug. * A line will be drawn from tragus of the ear to the outer canthus of the eye with ink. * Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line. Intra-operative procedures - continued in both groups: * Lavage is performed with 100 ml of saline solution. * 1 ml of Hyaluronic acid is injected into the superior joint space. * Puncture point is covered with sterile dressing for 24 hours | Procedure or surgery | Conventional arthrocentesis |
Primary outcome
Maximum mouth opening
Time frame: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Maximum mouth opening of the patient will be measured in Millimetre (mm) using a ruler
Joint pain
Time frame: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Joint pain: Will be measured by visual analogue scale (VAS) of 10 units according to pre-determined reference values: 0 No pain. 1-2 Faint pain. 3-4 Mild pain 5-6 Moderate pain. 7-8 Severe pain. 9-10 Excruciating pain.
1 secondary outcome
Operation time
Time frame: Once during every procedure
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 6 Aug 2025.
- Background: PubMed 25702588Dong XY, He S, Zhu L, Dong TY, Pan SS, Tang LJ, Zhu ZF. The diagnostic value of high-resolution ultrasonography for the detection of anterior disc displacement of the temporomandibular joint: a meta-analysis employing the HSROC statistical model. Int J Oral Maxillofac Surg. 2015 Jul;44(7):852-8. doi: 10.1016/j.ijom.2015.01.012. Epub 2015 Feb 20.
- Background: PubMed 35795636Maranini B, Ciancio G, Mandrioli S, Galie M, Govoni M. The Role of Ultrasound in Temporomandibular Joint Disorders: An Update and Future Perspectives. Front Med (Lausanne). 2022 Jun 20;9:926573. doi: 10.3389/fmed.2022.926573. eCollection 2022.
- Background: PubMed 18223525Poveda Roda R, Diaz Fernandez JM, Hernandez Bazan S, Jimenez Soriano Y, Margaix M, Sarrion G. A review of temporomandibular joint disease (TMJD). Part II: Clinical and radiological semiology. Morbidity processes. Med Oral Patol Oral Cir Bucal. 2008 Feb 1;13(2):E102-9.
- Background: PubMed 30412740Champs B, Corre P, Hamel A, Laffite CD, Le Goff B. US-guided temporomandibular joint injection: Validation of an in-plane longitudinal approach. J Stomatol Oral Maxillofac Surg. 2019 Feb;120(1):67-70. doi: 10.1016/j.jormas.2018.10.008. Epub 2018 Nov 6.
- Background: PubMed 30923970Bhargava D, Thomas S, Pawar P, Jain M, Pathak P. Ultrasound-guided arthrocentesis using single-puncture, double-lumen, single-barrel needle for patients with temporomandibular joint acute closed lock internal derangement. Oral Maxillofac Surg. 2019 Jun;23(2):159-165. doi: 10.1007/s10006-019-00753-6. Epub 2019 Mar 28.
- Background: PubMed 30719601Azlag Pekince K, Caglayan F, Pekince A. The efficacy and limitations of USI for diagnosing TMJ internal derangements. Oral Radiol. 2020 Jan;36(1):32-39. doi: 10.1007/s11282-019-00376-3. Epub 2019 Feb 4.
- Individual participant dataSharing planned: Yes. share it with other researchers websites if it is possible
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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.
Gamal Moutaed, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided arthrocentesis of tempromandibular joint and Conventional anatomically guided arthrocentesis of tempromandibular joint in people with Internal Derangement of the Tempromandibular Joint, run by Samiha Abdelsalam Abdelaziz Abdelaziz.
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 4 inclusion and 3 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 6 Aug 2025. 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 Samiha Abdelsalam Abdelaziz (+201100791990, samiha.abdelaziz@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: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 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?
On the ClinicalTrials.gov record for NCT06657118, which also lists 6 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 6 Aug 2025.