Transport Distraction Osteogenesis for Ramus-Condyle Unit

Sponsor

Hams Hamed Abdelrahman (Other)

Overall Status

Completed

CT.gov ID

NCT04383964

Collaborator

(none)

Enrollment

Location

Arm

18.4

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

this study was done to evaluate the use of transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with unilateral or bilateral TMJ ankylosis to correct the resultant deformity

Condition or Disease	Intervention/Treatment	Phase
Bilateral or Unilateral Deficient Ramus-condyle Unit	Device: Distraction Osteogenesis for Reconstruction of Ramus-Condyle	N/A

Detailed Description

10 patients with post ankylosis deficient ramus /condyle unit who underwent release procedure in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt.

all patients were assessed clinically and by imaging using OPG, lateral and PA cephalometry, and cone beam CT to assess the deficient ramus/condyle unit (RCU) then patients were operated using transport distraction osteogenesis to lengthen the RCU. Then follow up of all patients both clinically and radiographically was adopted.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Transport Distraction Osteogenesis for Reconstruction of Ramus-Condyle Unit Following Release of Temporomandibular Joint Ankylosis

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Apr 27, 2018

Actual Study Completion Date :

Jul 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transport distraction osteogenesis Locally made and designed submerged monodirectional in the vertical (Y) axis distractor was used. A transport disc is created at the remaining stump of the RCU with an L shaped osteotomy. The prepared disc is to be wide enough to fit the upper portion of the distrcator. The submerged distractor will be placed in a position to guide the transport disc moving up and backwards toward the glenoid fossa. The length of the distractor is determined according to the amount of distraction planned to reach the glenoid fossa.	Device: Distraction Osteogenesis for Reconstruction of Ramus-Condyle transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with TMJ ankylosis to correct the resultant deformity either unilaterally or bilaterally.

Arm

Intervention/Treatment

Experimental: Transport distraction osteogenesis

Locally made and designed submerged monodirectional in the vertical (Y) axis distractor was used. A transport disc is created at the remaining stump of the RCU with an L shaped osteotomy. The prepared disc is to be wide enough to fit the upper portion of the distrcator. The submerged distractor will be placed in a position to guide the transport disc moving up and backwards toward the glenoid fossa. The length of the distractor is determined according to the amount of distraction planned to reach the glenoid fossa.

Device: Distraction Osteogenesis for Reconstruction of Ramus-Condyle

transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with TMJ ankylosis to correct the resultant deformity either unilaterally or bilaterally.

Outcome Measures

Primary Outcome Measures

Jaw movements (changes in jaw movements through 18 months follow up) [at 3rd, 6th and 18th months]
Mouth opening in mm, Jaw movement in lateral excursion and opening.
Ramus height (changes of ramus heights through 18 months follow up) [at 3rd and 6th months]
Determination of the height of the ramus by PA cephalometric, Lateral cephalometric x-rays and tracings

Secondary Outcome Measures

Occlusal discrepancy or anterior open bite [18th months]
Occlusal discrepancy or anterior open bite

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Post ankylosis deformity: Bilateral or unilateral deficient ramus-condyle unit (RCU) after TMJ release

Exclusion Criteria:

Mentally affected patients.
Medically compromised patients.
Post menopausal osteoporosis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Alexandria	Azarita	Egypt	00203

Sponsors and Collaborators

Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hams Hamed Abdelrahman, Assistant lecturer, Alexandria University

ClinicalTrials.gov Identifier:

NCT04383964

Other Study ID Numbers:

Distraction Osteogenesis

First Posted:

May 12, 2020

Last Update Posted:

Jul 23, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 23, 2020