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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07108946
Enrollment
135
Registered
2025-08-07
Start date
2025-07-26
Completion date
2025-12-30
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Auricular scan

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.

Detailed description

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.

Interventions

OTHERBlack background

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

OTHERWhite background

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

OTHERParticipant own skin as a background

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

Sponsors

yasmine Elsherbeeny
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. Three types of skin tones will be selected; type I, type III and type VI according to The Fitzpatrick Scale. 2. Participants with intact ears. 3. Participants not exposed to sun burns or tans.

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026