Deviation Parameters of Intraorfal Scanning in Capturing Different Intraoral Defects

September 1, 2024 updated by: Fatima Elmougi, Cairo University

Deviation Parameters of Intraoral Scanning with and Without Artificial Markers Versus Conventional Impression of Total, Partial and Congenital Nasal Defects: a Pilot Non-Randomized Clinical Trial

For all participants, a conventional facial impression will be done using silicone material then poured and scanned using a desktop scanner which represented the control group (Group 1).

Group 2, involves nasal defects which will be optically scanned using IOS(medit 700 wireless) without facial markers Group 3 involves nasal defects which will be optically scanned using IOS(medit 700 wireless) with facial markers.

STL files of the facial scans and scanned cast obtained from the impression will be exported and saved to be used later for outcome assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11865
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • isolated nasal defects either, total or subtotal.
  • congenitally missing external nose with healthy and intact remaining facial structures.

Exclusion Criteria:

  • Any debilitating medical condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physical impression
Device: Physical Impression
Recording different types of nasal defects using physical impressions
Experimental: Scanning using intraoral scanner without markers
Device: Scanning using intraoral scanner without markers
Scanning different types of nasal defects using intraoral scanner without skin markers.
Experimental: Scanning using Intraoral scanner with markers
Device: Scanning using intraoral scanner with markers
Scanning different types of nasal defects using intraoral scanner with skin markers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dimensional accuracy of intraoral scanners
Time Frame: Day 0
measuring dimensional accuracy of diffrent scanning techniques using intraoral scanners
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

February 20, 2024

Study Completion (Actual)

February 20, 2024

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

September 1, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 36124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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