Computer Guided Arthrocentesis of Temporomandibular

NCT ID: NCT03844971

Last Updated: 2019-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-12

Study Completion Date

2020-03-08

Brief Summary

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

Detailed Description

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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

Conditions

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Temporomandibular Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Case series A trial will be carried out in hospital of oral and maxillofacial surgery department faculty of dentistry
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Single grouped study

Study Groups

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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

Group Type EXPERIMENTAL

Computer assisted arthrocentesis of

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Computer guided surgery

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Kareem Mahmoud

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed A Mounir

Role: STUDY_DIRECTOR

Cairo University

Locations

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Faculty of dentistry

Giza, ElManial, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Kareem M Yehia

Role: CONTACT

+201120268960

Facility Contacts

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Kareem M Yehia, Bcs

Role: primary

+201120268960

Sherif M Ali, Phd

Role: backup

+201001932020

References

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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.

Reference Type BACKGROUND
PMID: 29406255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19444109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29655411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29256465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29764480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30446325 (View on PubMed)

Other Identifiers

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CEBD-CU-2019-02-16

Identifier Type: -

Identifier Source: org_study_id

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