Oral & Maxillofacial department - Faculty of Dentistry - Cairo University.
Cairo, Cairo Governorate, 11553, Egypt
Location status: Recruiting
NCT Number: NCT06790628
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
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Cairo, Cairo Governorate, 11553, Egypt
Location status: Recruiting
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
Design:
A randomized controlled trial with parallel groups and a 1:1 allocation ratio. The study will assess facial symmetry and patient satisfaction over 12 months post-surgery.
Population:
Patients requiring mandibular reconstruction due to conditions like tumors, trauma, or osteomyelitis, with mandibular defects greater than 9 cm.
Interventions:
Group 1: Fibula free flap fixated at the alveolar level (prosthetically favorable position).
Group 2: Fibula free flap fixated at the inferior border level (conventional position).
Setting:
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University.
Duration:
Follow-up over 12 months post-surgery, with key data collection points at baseline, 3 days, 1 week, 1 month, 6 months, and 12 months postoperatively.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
surgical technique used in reconstructive surgery where a segment of the fibula bone, along with its blood vessels, is taken from the lower leg and transplanted to reconstruct defects in the mandible due to its length, strength, and ability to support dental implants.
The blood vessels are connected to nearby vessels at the reconstruction site to ensure the bone's survival and integration.
The procedure is highly versatile and often referred to as the "gold standard" for mandibular reconstruction.
Time frame: 6-12 months
Tool: 3D Stereophotogrammetry face scan. Unit: RMSD: root mean square deviation (Millimeters). Method: superimposition of the face scan color maps on Materialise's Interactive Medical Image Control System (MIMICS) Software.
Time frame: 6-12 months
Tool: Questionnare (Visual analogue scale) Unit: Scale (1-10)
Contact information is provided by the study sponsor or research team.
Adel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery
CONTACT
Mohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery
CONTACT
Cairo University
Other
Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction: a Randomized Controlled Trial.
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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.
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