Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement.

NCT06657118 | Not Yet Recruiting

• 1 other identifier: US guided arthrocentesis
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Internal Derangement of the Tempromandibular Joint

Outcome Measures

Primary Outcomes (2)

• Maximum mouth opening

  Maximum mouth opening of the patient will be measured in Millimetre (mm) using a ruler

  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.

  Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.

Secondary Outcomes (1)

• Operation time

  Once during every procedure

Study Arms (2)

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

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

Procedure: Ultrasound guided arthrocentesis of tempromandibular joint

Interventions

Ultrasound guided arthrocentesis of tempromandibular joint PROCEDURE

* 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

Ultrasound guided arthrocentesis

Conventional anatomically guided arthrocentesis of tempromandibular joint PROCEDURE

* 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

Conventional arthrocentesis

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patient with uncontrolled systemic diseases precluding administration of general anesthesia.
• Handicaps and special needs patients.
• Prisoners.

Sponsors & Collaborators

• Samiha Abdelsalam Abdelaziz Abdelaziz: lead

Related Publications (6)

• 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.

  PMID: 25702588 BACKGROUND

• Maranini 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.

  PMID: 35795636 BACKGROUND

• Poveda 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.

  PMID: 18223525 BACKGROUND

• Champs 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.

  PMID: 30412740 BACKGROUND

• Bhargava 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.

  PMID: 30923970 BACKGROUND

• Azlag 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.

  PMID: 30719601 BACKGROUND

Study Officials

• Gamal Moutaed, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Samiha Abdelsalam Abdelaziz

CONTACT

+201100791990; samiha.abdelaziz@dentistry.cu.edu.eg

Moataz Bahaa, Lecturer

CONTACT

+201005609359; moataz.bahaa@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: A randomized control trial, parallel group, allocation ratio 1:1 Framework equivalence

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share