Clinical Trials Directory

Trials / Completed

CompletedNCT05708339

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Fatima Elmougi · Academic / Other
Sex
All
Age
10 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERvirtually fabricated ear prosthesisvirtually designed ear prosthesis
OTHERconventionally fabricated ear prosthesisconventionally fabricated ear prosthesis

Timeline

Start date
2019-12-20
Primary completion
2021-05-12
Completion
2021-08-15
First posted
2023-02-01
Last updated
2023-02-01

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05708339. Inclusion in this directory is not an endorsement.