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

Primary Purpose

Ear Deformity External

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
virtually fabricated ear prosthesis
conventionally fabricated ear prosthesis
Sponsored by
Fatima Elmougi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ear Deformity External

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventionally fabricated ear prosthesis

virtually fabricated ear prosthesis

Arm Description

Outcomes

Primary Outcome Measures

Prosthesis adaptation using Silicon replica measuring technique.
measuring gap between prosthesis and defect

Secondary Outcome Measures

Full Information

First Posted
December 29, 2022
Last Updated
January 23, 2023
Sponsor
Fatima Elmougi
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1. Study Identification

Unique Protocol Identification Number
NCT05708339
Brief Title
Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects
Official Title
Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
August 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fatima Elmougi

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ear Deformity External

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventionally fabricated ear prosthesis
Arm Type
Active Comparator
Arm Title
virtually fabricated ear prosthesis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
virtually fabricated ear prosthesis
Intervention Description
virtually designed ear prosthesis
Intervention Type
Other
Intervention Name(s)
conventionally fabricated ear prosthesis
Intervention Description
conventionally fabricated ear prosthesis
Primary Outcome Measure Information:
Title
Prosthesis adaptation using Silicon replica measuring technique.
Description
measuring gap between prosthesis and defect
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11865
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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