Computer Guided Arthrocentesis of Temporomandibular

Not Applicable

• Conditions: Temporomandibular Disorder
• Interventions: Procedure: Computer assisted arthrocentesis of

• Registration Number: NCT03844971
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2019-01-12
• Status Verified: 2019-02
• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22
• Primary Completion: 2019-12-20
• Study Completion: 2020-03-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computer assisted surgery	Computer assisted arthrocentesis of	Intervention will be fabrication of patient specific surgical guide for arthrocentesis of temporomandibular joint for patients with anterior disc displacement with reduction using patient computed tomography with the aid of computer aided surgical simulation software

Primary Outcome Measures

Name	Time	Method
Accuracy	Intraoperative	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
Patient satisfaction	6 months postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Maximal mouth opening	6 month postoperatively	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.

Trial Locations

Locations (1)

Faculty of dentistry; 🇪🇬 Giza, ElManial, Egypt