the Effect of Different Background Color and Skin Tone on the Accuracy of Auricular Scanning

NCT07108946 | Enrolling By Invitation

• 1 other identifier: FDASU-Rec IR032512
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to find the best miss and match background color around an ear when taking scans for it , the investigators will recruit participants of three different skin tone and will scan their ear three times; one scan without any background, second scan with black one and the third scan with white background, then the investigators will take an actual physical impression of the participants ear and the investigators will obtain a cast which will be scanned also and its scan will be compared to the three scans taken with different backgrounds to find the best combination.

Conditions

Healthy Participants

Keywords

Auricular scan

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effect of different backgrounds and skin tones on trueness of auricular scans via intraoral scanner.

  The resultant standard tessellation files (STL) of every scan done via the intraoral scanner will be compared to the STL of the scan done via the extraoral scanner of the same participant by a metrological software to evaluate trueness.

  The study is expected to take place over a 6-week period. Each participant will be scheduled for one session lasting approximately one hour.

Study Arms (3)

Type I Fitzpatrick Scale skin tone participant

EXPERIMENTAL

participants of this skin tone will have their ears scanned across three different backgrounds.

Other: Black background; Other: White background; Other: Participant own skin as a background

Type III Fitzpatrick Scale skin tone participant

EXPERIMENTAL

participants of this skin tone will have their ears scanned across three different backgrounds.

Other: Black background; Other: White background; Other: Participant own skin as a background

Type IV Fitzpatrick Scale skin tone participant

EXPERIMENTAL

participants of this skin tone will have their ears scanned across three different backgrounds.

Other: Black background; Other: White background; Other: Participant own skin as a background

Interventions

Black background OTHER

Changing the background color during scanning to evaluate its effect on scan quality .

Type I Fitzpatrick Scale skin tone participant; Type III Fitzpatrick Scale skin tone participant; Type IV Fitzpatrick Scale skin tone participant

White background OTHER

Changing the background color during scanning to evaluate its effect on scan quality .

Type I Fitzpatrick Scale skin tone participant; Type III Fitzpatrick Scale skin tone participant; Type IV Fitzpatrick Scale skin tone participant

Participant own skin as a background OTHER

Changing the background color during scanning to evaluate its effect on scan quality .

Type I Fitzpatrick Scale skin tone participant; Type III Fitzpatrick Scale skin tone participant; Type IV Fitzpatrick Scale skin tone participant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Three types of skin tones will be selected; type I, type III and type VI according to The Fitzpatrick Scale.
• Participants with intact ears.
• Participants not exposed to sun burns or tans.

You may not qualify if:

• Uncooperative participants.
• Participants without intact ears.

Sponsors & Collaborators

• yasmine Elsherbeeny: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Abbasya, 11566, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of prosthodontics, faculty of dentistry, ain shams university

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 7, 2025
• Study Start: July 26, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

EG (1)