Digital VS. Conventional Ear Impression

Study Overview
=================
Brief Summary
-----------------
What is known: Ear impressions are made in conventional manner by impression materials which may affect the accuracy of the obtained data and consume time and effort . What this study adds: Predesigned ear markers facilitate ear scanning using an intraoral scanner that decreases the probability of in-accuracies using the conventional manner with less time and effort

Detailed Description
-----------------
Prosthodontic maxillofacial rehabilitation of acquired or congenital ear defects is considered a challenging procedure. This clinical trial introduces a novel approach for digital scanning of the unaffected contralateral ear using an intraoral scanner in comparison to the conventional impression techniques. CAD/CAM is a very promising design and fabrication of an auricular prosthesis for patients with unilateral ear defects. Purpose: This study aims to compare digital impression technique using an intra-oral digital scanner IOSfor the unaffected ear with markers /without markers versus traditional techniques with hydro colloidal impression materials.

Official Title
-----------------
An Innovative Approach for Auricular Rehabilitation Using Two Types Digital Impression Versus Conventional Techniques:

Conditions
-----------------
Patient Loss His Ear and Need Auricular Prosthesis

Intervention / Treatment
-----------------
* Device: medit intra oral scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any normal patient Exclusion criteria: no exclusion criteria
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control clinical rial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional ear impression<br> | Device: medit intra oral scanner<br>* ear scanning with intra oral scanner<br>|
| Experimental: digital auricular impression without marker using intra oral scanner<br> | Device: medit intra oral scanner<br>* ear scanning with intra oral scanner<br>|
| Experimental: digital auricular impression with marker using intra oral scanner<br> | Device: medit intra oral scanner<br>* ear scanning with intra oral scanner<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total deviation between Conventional auricular impression and two types of digital impression |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total deviation between two types of digital impression |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ear impression -Ear scanning-intraoral scanner-scannin marker-ear prosthesis