Scan Time and Prosthetic Complications of Intraoral Scanning Versus Intraoral Photogrammetry for Full-Arch Titanium Framework With Zirconia Overlay Implant Screw-Retained Prostheses

Официальное название

Scan Time and Prosthetic Complications of Intraoral Scanning Versus Intraoral Photogrammetry for Full-Arch Titanium Framework With Zirconia Overlay Implant Screw-Retained Prostheses: A Randomized Clinical Trial

Обзор

This study aims to evaluate the effect of intra-oral scanning and intra-oral photogrammetry on scan time and prosthetic complications in patients receiving full-arch titanium framework with zirconium overlay implant screw-retained prostheses. Participants will: Receive a full arch implant prosthesis and scan time will be recorded. Prosthetic complications (e.g., screw loosening, framework fracture, zirconia chipping) will be recorded at 3 and 6-month follow-up period post-delivery and we will manage complications at the time of prosthetic complication occurrence.

Вмешательства

• Устройство Intraoral photogrammetry (IOP)
  IOP will be used in the study to take a digital impression for the implants. The scanner will be used to record the soft tissue anatomy and trans-mucosal abutments. 3D Scan bodies will be fitted on the trans-mucosal abutments that are screwed on the implants to capture their position and scanning will be done. A scan of the soft tissue and scan bodies will finally be conducted.
• Устройство Intraoral scanner (IOS)
  Intra-oral scanner will be used in the study to take a digital impression for the implants. 3D printed generic Scan bodies with unified shape and length replacing the traditional transfer copings will be press fitted on the trans-mucosal abutments and pickup cylinders that are screwed on the implants to capture their position and intra-oral scanning will be done.

Первичные конечные точки

• Scan time [Срок оценки: At week 1 during the clinical visit of scanning the arch and bite registration.]

Вторичные конечные точки (1)

• Prosthetic complications [Срок оценки: At 3, 6 months of delivery of final prosthesis.]

Критерии участия

Критерии включения

• Patients requiring maxillary and/or mandibular full arch screw-retained implant-supported prosthesis.
• Number of implants placed per arch ranging from 4-6 implants per arch.
• Completely edentulous patients with sufficient inter-arch space to receive fixed prosthesis (Crown height space 9-15 mm per arch).
• Adequate zone of keratinized mucosa (> 2mm width).
• Both genders.
• Acceptable oral hygiene.
• Cooperative patients.
• Controlled systemic diseases (Diabetes, hypertension).

Критерии исключения

• Completely edentulous patients with insufficient inter-arch space to receive fixed prosthesis (Crown height space lesser than 9mm per arch).
• Completely edentulous patients with in-adequate zone of keratinized mucosa (< 2mm).
• Un cooperative patients.
• Poor oral hygiene.
• Uncontrolled systemic diseases (Diabetes, hypertension).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University — Cairo

Идентификаторы

NCT: NCT07446790 · 30725

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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