Mandibular Tumors Clinical Trial
Official title:
Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using Free Fibular Flap With and Without CAD/CAM Customized Osteotomy Guide (A Randomized Controlled Clinical Trial)
NCT number | NCT03757273 |
Other study ID # | 653 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2019 |
Est. completion date | February 2021 |
The purpose of this study is to compare Aesthetic results and operation time of free fibular flap with and without CAD/CAM customized osteotomy guide for reconstruction of mandibular defects.
Status | Recruiting |
Enrollment | 22 |
Est. completion date | February 2021 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients affected by tumor involving Mandibular bone. Exclusion Criteria: - Patients having poor oncological prognosis - Patients with poor performance status together with other relative or absolute vascular contraindication. - Patients require marginal resection or with bilateral fibular fracture |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry- Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aesthetic | Aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to the other side of the mandible. subjectively will be evaluated using VAS. | at least three months post operative | |
Secondary | Operation time | Operation time will be recorded intraoperatively in the surgery day as total operation time and ischemia time. | intraoperative |