Computer Guided Arthrocentesis of Temporomandibular

Temporomandibular Disorder Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03844971
• Other study ID #: CEBD-CU-2019-02-16
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2019
• Est. completion date: March 8, 2020

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: Kareem M Yehia
• Phone: +201120268960
• Email: kareem.kamal[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: March 8, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• Computer assisted arthrocentesis of
Under general anesthesia : patients specific preoperative prefabricated surgical guide will be used intraoperative for arthrocentesis of temporomandibular joint for patients with anterior disc displacement with reduction

Locations

Country	Name	City	State
Egypt	Faculty of dentistry	Giza	ElManial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	The primary outcome is the accuracy of the needle position in the superior joint space. It is binary outcome measured as yes or no. Aggregation will be done by percentage of successful cases number in the study. Calculation of the mean of all cases will be performed for analysis of the results	Intraoperative
Primary	Patient satisfaction	Recording preoperative and 9 consecutive postoperative numerical records over 6 months will be done. Percentage of successful cases number in the study will be aggregated. Calculation of the mean of all cases will be performed for analysis of the results.	6 months postoperatively
Secondary	Maximal mouth opening	Measuring preoperative and 9 consecutive postoperative maximal mouth opening over 6 months will be done. The measuring unit is millimetres. Percentage of successful cases number in the study will be aggregated. Calculation of the mean of all cases will be performed for analysis of the results.	6 month postoperatively