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Computer Guided Arthrocentesis of Temporomandibular

Primary Purpose

Temporomandibular Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Computer assisted arthrocentesis of
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Arthrocentesis, Computer assisted surgery, Anterior disc displacement with reduction

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of dentistryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computer assisted surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 15, 2019
Last Updated
February 20, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03844971
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Anticipated)
Study Completion Date
March 8, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
Arthrocentesis, Computer assisted surgery, Anterior disc displacement with reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computer assisted surgery
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Computer assisted arthrocentesis of
Other Intervention Name(s)
Computer guided surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Accuracy
Description
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
Time Frame
Intraoperative
Title
Patient satisfaction
Description
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.
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
Maximal mouth opening
Description
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.
Time Frame
6 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kareem M Yehia
Phone
+201120268960
Email
kareem.kamal@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Mounir
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of dentistry
City
Giza
State/Province
ElManial
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kareem M Yehia, Bcs
Phone
+201120268960
Email
kareem.kamal@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Sherif M Ali, Phd
Phone
+201001932020
Email
Sherif.ali@dentistry.cu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29406255
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.
Results Reference
background
PubMed Identifier
19444109
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.
Results Reference
background
PubMed Identifier
29655411
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.
Results Reference
background
PubMed Identifier
29256465
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.
Results Reference
background
PubMed Identifier
29764480
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.
Results Reference
background
PubMed Identifier
30446325
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.
Results Reference
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Computer Guided Arthrocentesis of Temporomandibular

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