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Computer Guided Arthrocentesis of Temporomandibular

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ClinicalTrials.gov Identifier: NCT03844971
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Kareem Mahmoud, Cairo University

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

Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Procedure: Computer assisted arthrocentesis of Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Case series A trial will be carried out in hospital of oral and maxillofacial surgery department faculty of dentistry
Masking: None (Open Label)
Masking Description: Single grouped study
Primary Purpose: Treatment
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)
Actual Study Start Date : January 12, 2019
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : March 8, 2020

Arm Intervention/treatment
Experimental: Computer assisted surgery
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
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
Other Name: Computer guided surgery




Primary Outcome Measures :
  1. Accuracy [ Time Frame: 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

  2. Patient satisfaction [ Time Frame: 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 :
  1. Maximal mouth opening [ Time Frame: 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.



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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844971


Contacts
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Contact: Kareem M Yehia +201120268960 kareem.kamal@dentistry.cu.edu.eg

Locations
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Egypt
Faculty of dentistry Recruiting
Giza, ElManial, Egypt, 12613
Contact: Kareem M Yehia, Bcs    +201120268960    kareem.kamal@dentistry.cu.edu.eg   
Contact: Sherif M Ali, Phd    +201001932020    Sherif.ali@dentistry.cu.edu   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Mohamed A Mounir faculty of dentistry Cairo university

Publications:
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Responsible Party: Kareem Mahmoud, Resident, Cairo University
ClinicalTrials.gov Identifier: NCT03844971     History of Changes
Other Study ID Numbers: CEBD-CU-2019-02-16
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kareem Mahmoud, Cairo University:
Arthrocentesis
Computer assisted surgery
Anterior disc displacement with reduction
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes