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

Fatima Elmougi

Status: Completed

Conditions: Ear Deformity External

Treatments: Other: conventionally fabricated ear prosthesis; Other: virtually fabricated ear prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT05708339

19115

Details and patient eligibility

About

: 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.

Enrollment: 15 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

conventionally fabricated ear prosthesis

Active Comparator group

Treatment:

Other: conventionally fabricated ear prosthesis

virtually fabricated ear prosthesis

Experimental group

Treatment:

Other: virtually fabricated ear prosthesis