Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects

Not Applicable

Completed

• Conditions: Ear Deformity External
• Interventions: Other: conventionally fabricated ear prosthesis; Other: virtually fabricated ear prosthesis

• Registration Number: NCT05708339
• Lead Sponsor: Fatima Elmougi

Brief Summary

: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-20
• Primary Completion: 2021-05-12
• Study Completion: 2021-08-15
• Study First Submitted: 2022-12-29
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Study First Posted: 2023-02-01
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients with missing or severely deformed ears.
• Patients with failed autogenous reconstruction.
• Compliant and cooperative patients.
• Patients committed to maintain the prosthesis.
• Patients willing to attend the follow up appointments.

Exclusion Criteria

• Patients undergoing radiotherapy or chemotherapy treatment.
• Patients taking corticosteroids or bisphosphonates.
• Patients with contraindications for CT scanning.
• Patients with any debilitating medical condition.
• Patients with any type of psychosomatic disorder.
• Patients allergic to any of the materials used.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventionally fabricated ear prosthesis	conventionally fabricated ear prosthesis	-
virtually fabricated ear prosthesis	virtually fabricated ear prosthesis	-

Primary Outcome Measures

Name	Time	Method
Prosthesis adaptation using Silicon replica measuring technique.	Day 1	measuring gap between prosthesis and defect

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt