Transport Distraction Osteogenesis for Ramus-Condyle Unit

Bilateral or Unilateral Deficient Ramus-condyle Unit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383964
• Other study ID #: Distraction Osteogenesis
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: July 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 15, 2019
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bilateral or Unilateral Deficient Ramus-condyle Unit

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Alexandria	Azarita

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Occlusal discrepancy or anterior open bite	Occlusal discrepancy or anterior open bite	18th months