Transport Distraction Osteogenesis for Ramus-Condyle Unit

Not Applicable

Completed

• Conditions: Bilateral or Unilateral Deficient Ramus-condyle Unit
• Interventions: Device: Distraction Osteogenesis for Reconstruction of Ramus-Condyle

• Registration Number: NCT04383964
• Lead Sponsor: Hams Hamed Abdelrahman

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

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-04-27
• Study Completion: 2019-07-15
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transport distraction osteogenesis	Distraction Osteogenesis for Reconstruction of Ramus-Condyle	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Occlusal discrepancy or anterior open bite	18th months	Occlusal discrepancy or anterior open bite

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Alexandria, Azarita, Egypt