Accuracy of Digital vs Conventional Denture Impressions: An In Vivo Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Digital and conventional impressions.
- Кому может быть актуально
- Состояния в реестре: Edentulism, Complete Dentures, Digital Impression Accuracy, Dental Impression Techniques. Базовые параметры: 18 лет — 85 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- ОАЭ
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Accuracy of Intraorally Scanned Denture Impressions Compared to Conventional Border-Molded Impressions: An In Vivo Study
Обзор
The goal of this clinical trial is to compare the accuracy of two denture impression techniques, digital intraoral scanning and conventional border-molded impressions, in adults who have lost all their teeth (fully edentulous patients). The main questions it aims to answer are: Is a digital intraoral scan as accurate as a conventional impression for capturing the shape of the mouth, including movable gum areas? Are repeated digital scans consistent (precise) when taken multiple times on the same patient? Researchers will compare digital impressions taken with an intraoral scanner to conventional impressions made with custom trays and border molding to see if digital scans can match the accuracy of the traditional "gold standard" method. Participants will: Attend Dubai Dental Hospital for two study visits. Have their mouth scanned three times using a digital intraoral scanner. Have a conventional impression taken using a custom tray and high-accuracy material after border molding. Provide informed consent and allow their impression data to be analyzed for accuracy.
Вмешательства
- Процедура Digital and conventional impressions
Participants will first receive digital intraoral scanning of their fully edentulous upper and/or lower jaw using the TRIOS 5 intraoral scanner (3Shape). The scanning process follows a structured sequence to capture the entire arch, including the palate and ridge slopes. Each arch will be scanned three times during the same visit to assess precision (consistency of repeated scans). Then the same participants will also undergo a conventional impression procedure using a custom tray and border mol
Первичные конечные точки
- Trueness of Digital Impressions: Mean root mean square Deviation (mm) between intraoral scanner (IOS) digital impressions and conventional impression scans-per arch [Срок оценки: 1 week]
- Precision of Digital Impressions: Within-Subject Mean Pairwise RMS Deviation (mm) Across Three IOS Scans (Precision)-per Arch [Срок оценки: 1 week]
Вторичные конечные точки (2)
- The difference (mm) in mean RMS trueness between the maxillary and mandibular arches is measured. [Срок оценки: 1 week]
- Difference (mm) in mean RMS trueness between static (attached) and dynamic (mobile) regions. [Срок оценки: 1 week]
Критерии участия
Критерии включения
- Patients attending DDH for complete dental prosthesis.
- Fully edentulous patients
- All alveolar ridge classifications of Cawood and Howell 1988 (Cawood and Howell, 1988)
- Above 18 years old
- Arabic and English-speaking patients
- Good physical health (ASA class 1 or 2)
- Willing to provide informed consent.
Критерии исключения
- Dentate patients
- Implant-attachment-supported complete denture.
- Patients un-willing to participate (non-consented patients)
- Patients with severe gag reflex
- Patients who are mentally unstable, drug users or alcoholics
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
ОАЭ · 1 центр
- Dubai Dental Hospital — Dubai
Публикации
- Zarone F, Ruggiero G, Ferrari M, Mangano F, Joda T, Sorrentino R. Comparison of different intraoral scanning techniques on the completely edentulous maxilla: An in vitro 3-dimensional comparative analysis. J Prosthet Dent. 2020 Dec;124(6):762.e1-762.e8. doi: 10.1016/j.prosdent.2020.07.017. Epub 2020 Oct 24. PMID 33289648
- Al Hamad KQ, Al-Kaff FT. Trueness of intraoral scanning of edentulous arches: A comparative clinical study. J Prosthodont. 2023 Jan;32(1):26-31. doi: 10.1111/jopr.13597. Epub 2022 Sep 6. PMID 35997079
- Casucci A, Mazzitelli C, Tsiplakis V, D'Arienzo LF, Breschi L, Ferrari M. Digital Impressions in Edentulous Patients: A Systematic Review for Clinical Evidence. Int J Prosthodont. 2023 Sep 12;36(4):486-497. doi: 10.11607/ijp.7483. PMID 37699190
Идентификаторы
NCT: NCT07377890 · MBRU IRB-2024-107