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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Black background
  Changing the background color during scanning to evaluate its effect on scan quality .
• Другое White background
  Changing the background color during scanning to evaluate its effect on scan quality .
• Другое Participant own skin as a background
  Changing the background color during scanning to evaluate its effect on scan quality .

Первичные конечные точки

• Evaluation of the effect of different backgrounds and skin tones on trueness of auricular scans via intraoral scanner. [Срок оценки: The study is expected to take place over a 6-week period. Each participant will be scheduled for one session lasting approximately one hour.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 1- Uncooperative participants.

• 2-Participants without intact ears.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Египет · 1 центр

• Faculty of Dentistry, Ain Shams University — Cairo

Идентификаторы

NCT: NCT07108946 · FDASU-Rec IR032512

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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