Clinical trial NCT06657118: Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement.
Official title: Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Internal Derangement of the Tempromandibular Joint
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized control trial, parallel group, allocation ratio 1:1 Framework equivalence
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Maximum mouth opening
timeFrame: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
measure: Joint pain
timeFrame: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Secondary outcomes:
measure: Operation time
timeFrame: Once during every procedure
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Gamal Moutaed, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.