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Enrolling by Invitation

NCT Number: NCT07108946

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

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.

Enrolling by Invitation

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain Shams University

Cairo, Abbasya, 11566, Egypt

About this study

Manufacturing the Extraoral prosthesis is troublesome for the patient, the dental practitioner and the dental technician. When a person misses his ear congenitally or due to trauma, he wishes to have an accurate replacement for his ear with minimum steps and effort. Digital technology has been providing the dental field with the most helpful equipment in such cases. Owing to the innovation of intraoral scanners with its continuous refinement, this patient now can rest assured that he will have his auricular prosthesis with less number of visits and less effort. There are different environmental factors that can affect scanning accuracy such as patients skin tone and scanning background.This study aims to evaluate the different backgrounds and skin tones effect on the trueness of auricular scanning. Participants with different skin tones (black, white and intermediate) will be selected with intact ears, then conventional impression will be taken and stone cast will be obtained and scanned via an extraoral scanner, then intraoral scanner will be used to scan the auricle three times, first with a black background, second with white background, third without background. Trueness of the scans will be evaluated by metrological software. Data will be collected, tabulated, and statistically analyzed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 1- Uncooperative participants.
  • 2-Participants without intact ears.

Treatment and study plan

Black background

Other

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

White background

Other

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

Participant own skin as a background

Other

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

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

yasmine Elsherbeeny

Other

Registry information

Official study title

Influence of Skin Tone and Background Color on the Accuracy of Auricular Scanning: A Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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