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

yasmine Elsherbeeny

Status: Invitation-only

Conditions: Healthy Participants

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07108946

FDASU-Rec IR032512

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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135 participants in 3 patient groups

Type I Fitzpatrick Scale skin tone participant

Experimental group

Description:

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

Treatment:

Other: White background

Other: Black background

Other: Participant own skin as a background

Type III Fitzpatrick Scale skin tone participant

Experimental group

Description:

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

Treatment:

Other: White background

Other: Black background

Other: Participant own skin as a background

Type IV Fitzpatrick Scale skin tone participant

Experimental group

Description:

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

Treatment:

Other: White background

Other: Black background

Other: Participant own skin as a background