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Status unknownNCT03844971Updated Feb 22, 2019

Computer Guided Arthrocentesis of Temporomandibular

An interventional study of Computer assisted arthrocentesis of in Temporomandibular Disorder, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-02-22.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
15 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Temporomandibular Disorder

Keywords

  • Arthrocentesis
  • Computer assisted surgery
  • Anterior disc displacement with reduction
03

In context

Temporomandibular Joint Disorders

621 studies on the registry are indexed under Temporomandibular Joint Disorders; 161 are open to participants now.

This study's planned enrollment of 8 is below the median of 46 across 439 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureComputer 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

    Also known as: Computer guided surgery

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Intraoperative

  2. 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.

    Time frame: 6 months postoperatively

Secondary outcomes

  1. 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.

    Time frame: 6 month postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 29406255 ↗
  • 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. PubMed 19444109 ↗
  • 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. PubMed 29655411 ↗
  • 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. PubMed 29256465 ↗
  • 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. PubMed 29764480 ↗
  • 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. PubMed 30446325 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2019 (actual). Primary completion is estimated for Dec 2019, 11 months after the start.

Of 246 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 11 months is close to that.

Counting every sponsor, half of 250 studies reached it within 11 months; a quarter within 5 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2019
First posted
Feb 19, 2019
StartActual
Jan 12, 2019
Primary completionEst.
Dec 20, 2019
CompletionEst.
Mar 8, 2020
Last update
Feb 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03844971
Lead sponsor
Cairo University
Responsible party
Kareem Mahmoud (Resident, Cairo University) — Principal investigator
First posted
Feb 19, 2019
Start date
Jan 12, 2019
Primary completion
Dec 20, 2019 (estimated)
Completion
Mar 8, 2020 (estimated)
Last update
Feb 22, 2019

Study contacts

Kareem M Yehia
Contact
kareem.kamal@dentistry.cu.edu.eg
+201120268960
Mohamed A Mounir
study director · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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