An interventional study of virtually fabricated ear prosthesis and conventionally fabricated ear prosthesis in Ear Deformity External, sponsored by Fatima Elmougi. Completed at 1 site in Egypt. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-01.
Sponsored by Fatima Elmougi · Not applicable, Interventional, and Treatment
: patients were recruited for auricular prosthetic reconstruction. Preoperative data was collected including personal and medical history, plain photographs and CT scans. Pre-operative prosthetic and implant planning were carried out. Three endosseous implants were placed in a two-stage surgical technique. Patients were assigned into two groups with allocation ratio 1:1. In control group, Implant level impression was recorded, and a stone model of the defect was cast. waxing up of the ear was done on the stone cast followed by flasking, wax elimination, packing of heat cured acrylic resin and curing. In intervention group, CT scanning was done to the full head and optical scanning was done to the defect site with scan bodies screwed to the implants. Using Exocad software a model of the defect site with implant analogues and ear model with abutment extensions were planned and printed using SLA printing technology. A placement jig was done for ear models of both groups and adaptation was measured on the patient using silicon replica technique. The silicone replica was sectioned and the gap, represented in light consistency polyvinyl siloxane impression material was measured using digital microscope.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's enrollment of 15 is below the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.
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Exclusion Criteria:
Other: conventionally fabricated ear prosthesis
Other: virtually fabricated ear prosthesis
virtually designed ear prosthesis
conventionally fabricated ear prosthesis
Prosthesis adaptation using Silicon replica measuring technique.
measuring gap between prosthesis and defect
Time frame: Day 1
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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