Transport Distraction Osteogenesis for Ramus-Condyle Unit

NCT ID: NCT04383964

Last Updated: 2020-07-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-07-15

Brief Summary

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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

Detailed Description

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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.

Conditions

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Bilateral or Unilateral Deficient Ramus-condyle Unit

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Distraction Osteogenesis for Reconstruction of Ramus-Condyle

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Dentistry

Alexandria, Azarita, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Distraction Osteogenesis

Identifier Type: -

Identifier Source: org_study_id

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