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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05708339
Enrollment
15
Registered
2023-02-01
Start date
2019-12-20
Completion date
2021-08-15
Last updated
2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear Deformity External

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.

Interventions

OTHERvirtually fabricated ear prosthesis

virtually designed ear prosthesis

OTHERconventionally fabricated ear prosthesis

conventionally fabricated ear prosthesis

Sponsors

Fatima Elmougi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Prosthesis adaptation using Silicon replica measuring technique.Day 1measuring gap between prosthesis and defect

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026