Transport Distraction Osteogenesis for Ramus-Condyle Unit

Study Overview
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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.

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

Conditions
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Bilateral or Unilateral Deficient Ramus-condyle Unit

Intervention / Treatment
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* Device: Distraction Osteogenesis for Reconstruction of Ramus-Condyle


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transport distraction osteogenesis<br>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<br>* transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with TMJ ankylosis to correct the resultant deformity either unilaterally or bilaterally.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusal discrepancy or anterior open bite | Occlusal discrepancy or anterior open bite | 18th months |