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OpenTrials
Completed

NCT Number: NCT05708339

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

: 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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11865, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

virtually fabricated ear prosthesis

Other

virtually designed ear prosthesis

conventionally fabricated ear prosthesis

Other

conventionally fabricated ear prosthesis

Primary outcomes

  1. Prosthesis adaptation using Silicon replica measuring technique.

    Time frame: Day 1

    measuring gap between prosthesis and defect

Sponsors and collaborators

Lead sponsor

Fatima Elmougi

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2023
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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