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

Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects: a Randomized Controlled Trial.

: 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.

Study Overview

• Status: Completed
• Conditions: Ear Deformity External
• Intervention / Treatment: Other: conventionally fabricated ear prosthesis; Other: virtually fabricated ear prosthesis

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: conventionally fabricated ear prosthesis	Other: conventionally fabricated ear prosthesis; conventionally fabricated ear prosthesis
EXPERIMENTAL: virtually fabricated ear prosthesis	Other: virtually fabricated ear prosthesis; virtually designed ear prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthesis adaptation using Silicon replica measuring technique.	measuring gap between prosthesis and defect	Day 1

Collaborators and Investigators

• Sponsor: Fatima Elmougi

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2019
• Primary Completion (ACTUAL): May 12, 2021
• Study Completion (ACTUAL): August 15, 2021

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (ACTUAL): February 1, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 19115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No