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

NCT05708339 | Completed DMC

• 1 other identifier: 19115
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Ear Deformity External

Outcome Measures

Primary Outcomes (1)

• Prosthesis adaptation using Silicon replica measuring technique.

  measuring gap between prosthesis and defect

  Day 1

Study Arms (2)

conventionally fabricated ear prosthesis

ACTIVE COMPARATOR

Other: conventionally fabricated ear prosthesis

virtually fabricated ear prosthesis

EXPERIMENTAL

Other: virtually fabricated ear prosthesis

Interventions

virtually fabricated ear prosthesis OTHER

virtually designed ear prosthesis

virtually fabricated ear prosthesis

conventionally fabricated ear prosthesis OTHER

conventionally fabricated ear prosthesis

conventionally fabricated ear prosthesis

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatima Elmougi: lead

Study Sites (1)

Cairo University

Cairo, 11865, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: February 1, 2023
• Study Start: December 20, 2019
• Primary Completion: May 12, 2021
• Study Completion: August 15, 2021
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)