Computer Guided Arthrocentesis of Temporomandibular

NCT03844971 | Unknown DMC

• 1 other identifier: CEBD-CU-2019-02-16
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Temporomandibular Disorder

Keywords

Arthrocentesis; Computer assisted surgery; Anterior disc displacement with reduction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Maximal mouth opening

  6 month postoperatively

Study Arms (1)

Computer assisted surgery

EXPERIMENTAL

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

Interventions

Computer assisted arthrocentesis of 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

Also known as: Computer guided surgery

Computer assisted surgery

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry

Giza, ElManial, 12613, Egypt

RECRUITING

Related 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.

  PMID: 29406255 BACKGROUND

• 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.

  PMID: 19444109 BACKGROUND

• 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.

  PMID: 29655411 BACKGROUND

• 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.

  PMID: 29256465 BACKGROUND

• 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.

  PMID: 29764480 BACKGROUND

• 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.

  PMID: 30446325 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Mohamed A Mounir

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Kareem M Yehia

CONTACT

+201120268960; kareem.kamal@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Single grouped study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Case series A trial will be carried out in hospital of oral and maxillofacial surgery department faculty of dentistry

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: January 12, 2019
• Primary Completion: December 20, 2019
• Study Completion: March 8, 2020
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)