Clinical trial NCT03844971: Computer Guided Arthrocentesis of Temporomandibular
Official title: Evaluation of Accuracy of Computer Guided Arthrocentesis of Temporomandibular Joint for Patients With Anterior Disc Displacement With Reduction Using Patient Specific Guide (Case Series)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorder
Keywords: Arthrocentesis
Computer assisted surgery
Anterior disc displacement with reduction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 8
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series A trial will be carried out in hospital of oral and maxillofacial surgery department faculty of dentistry
Primary purpose: TREATMENT

Brief summary: Computer guided arthrocentesis of temporomandibular joint for patients with anterior disc displacement with reduction using patient specific guide

Detailed description: A consecutive, single centered prospective study. All the patients will be selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department. Faculty of dentistry- Cairo University Egypt.

Patients will be subjected to:

* Case history including personal data, medical, surgical and family history.
* Clinical examination
* Radiographic examination using magnetic resonance imaging (MRI) and computed tomography (C.T) bony and soft tissue window.
* Diagnostic studying casts, laser scanning of the casts in centric occlusion
* Preoperative anaesthesia assessment for fitness for general anaesthesia.
* Utilizing computer aided surgical simulation software a patient specific surgical guide is designed from the patients' segmented 3D soft tissue window with the following criteria:
* and fabrication of the surgical guide using c.t. scan with soft tissue and bony window, segmentation of the 3D model using Mimics 19.0 (medical engineering program), designing a 3D patient specific the guide is resting on skin of buccal and temporal area and occlusal bite block with a 3 openings i. The guide is resting on skin of buccal and temporal area and occlusal bite block with 3 openings ii. 2 depth controlled cylinders for input and output needles iii. 1 cylinder for arthroscopy trocar arm for verification of needle tip location in the superior joint space
* Then exporting the stl file to 3D printing machine before surgery All cases will undergo surgery under general anesthesia. The patient specific guide will be adapted on facial soft tissue overlying the temporomandibular joint . Fixation of the guide using occlusal bite-block on maxillary and mandibular teeth. Insertion of arthroscopic trocar through the depth controlled cylinder. Locating the superior joint space using arthroscopy. Insertion of input needle through the depth controlled cylinder. Verification of the needle position and angulation in the superior joint space by the arthroscopy. Infusion of 2ml lactated Ringer's solution then insertion of output needle and joint effusion by 300 ml of lactated Ringer's solution then infusing the joint by 2ml of hyaluronic acid.

Proper postoperative instructions will be given to the patient as soft diet for 1 week and immediate postoperative physiotherapy from the second day of operation and for 1 month. in addition to the postoperative medications including antibiotics (amoxicillin 500mg capsules t.i.d) and analgesics (diclofenac potassium 50mg as needed).Adherence to follow ups is also instructed

Eligibility criteria: Inclusion Criteria:

* Patients with anterior disc displacement with reduction
* Age group : from 15 to 60 years old
* No sex predilection
* Patients with no contraindications to surgical intervention

Exclusion Criteria:

* Patients with systemic condition counteracting with the surgical procedure.
* Patients with disc displacement without reduction
* Patients with osteoarthritis
* Patients suffering from myofacial pain
* Pregnant or lactating female

Primary outcomes:
measure: Accuracy
timeFrame: Intraoperative
measure: Patient satisfaction
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Maximal mouth opening
timeFrame: 6 month postoperatively
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of dentistry
state: ElManial
Study officials:
affiliation: Cairo University
name: Mohamed A Mounir
role: STUDY_DIRECTOR
References:
citation: Bas B, Kazan D, Kutuk N, Gurbanov V. The Effect of Exercise on Range of Movement and Pain After Temporomandibular Joint Arthrocentesis. J Oral Maxillofac Surg. 2018 Jun;76(6):1181-1186. doi: 10.1016/j.joms.2018.01.003. Epub 2018 Jan 12.
citation: Beumer HW, Puscas L. Computer modeling and navigation in maxillofacial surgery. Curr Opin Otolaryngol Head Neck Surg. 2009 Aug;17(4):270-3. doi: 10.1097/MOO.0b013e32832cba7d.
citation: Chang CL, Wang DH, Yang MC, Hsu WE, Hsu ML. Functional disorders of the temporomandibular joints: Internal derangement of the temporomandibular joint. Kaohsiung J Med Sci. 2018 Apr;34(4):223-230. doi: 10.1016/j.kjms.2018.01.004. Epub 2018 Feb 7.
citation: De Barros Melo MN, Dos Santos Melo JN, Sarmento VA, De Azevedo RA, Queiroz CS. Influence of arthrocentesis irrigation volume at temporomandibular disorder treatment. Indian J Dent Res. 2017 Nov-Dec;28(6):655-660. doi: 10.4103/ijdr.IJDR_422_15.
citation: Efeoglu C, Calis AS, Koca H, Yuksel E. A stepped approach for the management of symptomatic internal derangement of the temporomandibular joint. J Otolaryngol Head Neck Surg. 2018 May 15;47(1):33. doi: 10.1186/s40463-018-0282-y.
citation: Folle FS, Poluha RL, Setogutti ET, Grossmann E. Double puncture versus single puncture arthrocentesis for the management of unilateral temporomandibular joint disc displacement without reduction: A randomized controlled trial. J Craniomaxillofac Surg. 2018 Dec;46(12):2003-2007. doi: 10.1016/j.jcms.2018.10.015. Epub 2018 Oct 26.