NCT06315621

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

19 days

First QC Date

March 5, 2024

Last Update Submit

September 1, 2024

Conditions

Nasal Defect

Outcome Measures

Primary Outcomes (1)

  • Dimensional accuracy of intraoral scanners

    measuring dimensional accuracy of diffrent scanning techniques using intraoral scanners

    Day 0

Study Arms (3)

Physical impression

ACTIVE COMPARATOR
Device: Physical Impression

Scanning using intraoral scanner without markers

EXPERIMENTAL
Device: Scanning using intraoral scanner without markers

Scanning using Intraoral scanner with markers

EXPERIMENTAL
Device: Scanning using intraoral scanner with markers

Interventions

Scanning using intraoral scanner with markersDEVICE

Scanning different types of nasal defects using intraoral scanner with skin markers.

Scanning using Intraoral scanner with markers
Scanning using intraoral scanner without markersDEVICE

Scanning different types of nasal defects using intraoral scanner without skin markers.

Scanning using intraoral scanner without markers
Physical ImpressionDEVICE

Recording different types of nasal defects using physical impressions

Physical impression

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Any debilitating medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11865, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 18, 2024

Study Start

February 1, 2024

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

September 5, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)