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Completed

NCT Number: NCT04383964

Transport Distraction Osteogenesis for Ramus-Condyle Unit

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

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Key information

Conditions

Bilateral or Unilateral Deficient Ramus-condyle Unit

Age range

1 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, Azarita, 00203, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Distraction Osteogenesis for Reconstruction of Ramus-Condyle

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.

Primary outcomes

  1. Jaw movements (changes in jaw movements through 18 months follow up)

    Time frame: at 3rd, 6th and 18th months

    Mouth opening in mm, Jaw movement in lateral excursion and opening.

  2. Ramus height (changes of ramus heights through 18 months follow up)

    Time frame: at 3rd and 6th months

    Determination of the height of the ramus by PA cephalometric, Lateral cephalometric x-rays and tracings

Secondary outcomes

  1. Occlusal discrepancy or anterior open bite

    Time frame: 18th months

    Occlusal discrepancy or anterior open bite

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 12, 2020
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.