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CompletedNCT05708339Updated Feb 1, 2023

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

An interventional study of virtually fabricated ear prosthesis and conventionally fabricated ear prosthesis in Ear Deformity External, sponsored by Fatima Elmougi. Completed at 1 site in Egypt. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Fatima Elmougi · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Dec 2019, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
10 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ear Deformity External
03

In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's enrollment of 15 is below the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

This is the only study on the registry with Fatima Elmougi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    conventionally fabricated ear prosthesis

    Other: conventionally fabricated ear prosthesis

  • Experimental
    virtually fabricated ear prosthesis

    Other: virtually fabricated ear prosthesis

Interventions

  • Othervirtually fabricated ear prosthesis

    virtually designed ear prosthesis

  • Otherconventionally fabricated ear prosthesis

    conventionally fabricated ear prosthesis

06

What researchers measure

Primary outcomes

  1. Prosthesis adaptation using Silicon replica measuring technique.

    measuring gap between prosthesis and defect

    Time frame: Day 1

07

Study locations

1 site
  • Cairo University
    Cairo, 11865, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05708339
Lead sponsor
Fatima Elmougi
Responsible party
Fatima Elmougi (Doctor, Cairo University) — Sponsor-investigator
First posted
Feb 1, 2023
Start date
Dec 20, 2019
Primary completion
May 12, 2021
Completion
Aug 15, 2021
Last update
Feb 1, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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