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

Study Overview
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Brief Summary
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: 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.

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

Conditions
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Ear Deformity External

Intervention / Treatment
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* Other: virtually fabricated ear prosthesis
* Other: conventionally fabricated ear prosthesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventionally fabricated ear prosthesis<br> | Other: conventionally fabricated ear prosthesis<br>* conventionally fabricated ear prosthesis<br>|
| Experimental: virtually fabricated ear prosthesis<br> | Other: virtually fabricated ear prosthesis<br>* virtually designed ear prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthesis adaptation using Silicon replica measuring technique. | measuring gap between prosthesis and defect | Day 1 |