NCT04893902

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

1 day

First QC Date

May 14, 2021

Last Update Submit

May 14, 2021

Conditions

Patient Loss His Ear and Need Auricular Prosthesis

Keywords

Ear impression -Ear scanning-intraoral scanner-scannin marker-ear prosthesis

Outcome Measures

Primary Outcomes (1)

  • total deviation between Conventional auricular impression and two types of digital impression

    1 day

Secondary Outcomes (1)

  • total deviation between two types of digital impression

    1 day

Study Arms (3)

conventional ear impression

ACTIVE COMPARATOR
Device: medit intra oral scanner

digital auricular impression without marker using intra oral scanner

EXPERIMENTAL
Device: medit intra oral scanner

digital auricular impression with marker using intra oral scanner

EXPERIMENTAL
Device: medit intra oral scanner

Interventions

medit intra oral scannerDEVICE

ear scanning with intra oral scanner

conventional ear impressiondigital auricular impression with marker using intra oral scannerdigital auricular impression without marker using intra oral scanner

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • any normal patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Mahmoud dohiem

Cairo, 11742, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36117136DERIVED

Central Study Contacts

Mohamed M dohiem, lecturer

CONTACT

01002411965mdohiem@zu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: control clinical rial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecture prosthetic department zagazig university egypt

Study Record Dates

First Submitted

May 14, 2021

First Posted

May 20, 2021

Study Start

May 15, 2021

Primary Completion

May 16, 2021

Study Completion

May 17, 2021

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)