Digital VS. Conventional Ear Impression

NCT ID: NCT04893902

Last Updated: 2021-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2021-05-17

Brief Summary

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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

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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.

Conditions

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Patient Loss His Ear and Need Auricular Prosthesis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

control clinical rial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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conventional ear impression

Group Type ACTIVE_COMPARATOR

medit intra oral scanner

Intervention Type DEVICE

ear scanning with intra oral scanner

digital auricular impression without marker using intra oral scanner

Group Type EXPERIMENTAL

medit intra oral scanner

Intervention Type DEVICE

ear scanning with intra oral scanner

digital auricular impression with marker using intra oral scanner

Group Type EXPERIMENTAL

medit intra oral scanner

Intervention Type DEVICE

ear scanning with intra oral scanner

Interventions

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medit intra oral scanner

ear scanning with intra oral scanner

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* any normal patient
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mohamed Mahmoud Dohiem

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mohamed Mahmoud Dohiem

lecture prosthetic department zagazig university egypt

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Mohamed Mahmoud dohiem

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed M dohiem, lecturer

Role: CONTACT

01002411965

Facility Contacts

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Mohamed M dohiem, lecturer

Role: primary

00201002411965

References

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Dohiem MM, Emam NS, Abdallah MF, Abdelaziz MS. Accuracy of digital auricular impression using intraoral scanner versus conventional impression technique for ear rehabilitation: A controlled clinical trial. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4254-4263. doi: 10.1016/j.bjps.2022.08.002. Epub 2022 Aug 5.

Reference Type DERIVED
PMID: 36117136 (View on PubMed)

Other Identifiers

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dohiem md

Identifier Type: -

Identifier Source: org_study_id

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