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

NCT ID: NCT05708339

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-20
• Study Completion Date: 2021-08-15

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.

Conditions

Ear Deformity External

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventionally fabricated ear prosthesis

Group Type: ACTIVE_COMPARATOR

conventionally fabricated ear prosthesis

Intervention Type: OTHER

conventionally fabricated ear prosthesis

virtually fabricated ear prosthesis

Group Type: EXPERIMENTAL

virtually fabricated ear prosthesis

Intervention Type: OTHER

virtually designed ear prosthesis

Interventions

virtually fabricated ear prosthesis

virtually designed ear prosthesis

Intervention Type: OTHER

conventionally fabricated ear prosthesis

conventionally fabricated ear prosthesis

Intervention Type: OTHER

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fatima Elmougi

OTHER

Sponsor Role: lead

Responsible Party

Fatima Elmougi

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

19115

Identifier Type: -

Identifier Source: org_study_id