Truness of Full Arch Impressions in All on x Cases

Официальное название

Trueness of Full-Arch Impressions Using Photogrammetry, Splinted Digital Scan Bodies Versus Conventional Open-Tray Techniques in the All-on-x Prosthesis

Обзор

This study aims to compare the trueness and precision of three impression methodologies photogrammetry, digital intraoral scanning with splinted scan bodies, and conventional open tray impressions in the context of the All-on-X treatment concept. This will provide valuable evidence for clinicians considering digital workflows for implant-supported prostheses. Does the use of photogrammetry and digital impression techniques with splinted scan bodies result in improved accuracy in implant position transfer in the All-on-X concept compared to conventional open tray impressions?

Вмешательства

• Устройство photogrammetry based full arch impression
  use of photogrammetry system to capture the positions of All on X implants digitally without physical impression material. This technique aims to achieve precise measurements and increase patient satisfaction
• Устройство Digital Impression Using Splinted Scan Bodies
  Digital full-arch impression using splinted scan bodies connected with resin to enhance stability. An intraoral scanner captures the splinted assembly for framework fabrication. Accuracy and patient satisfaction will be evaluated.
• Процедура Conventional Open-Tray Implant Impression
  Traditional full-arch open-tray impression using polyether or VPS material with splinted impression copings. This serves as the standard comparator for evaluating accuracy and patient satisfaction.

Первичные конечные точки

• Accuracy measured using 3D inspection software (Geomagic Control X). [Срок оценки: Immediately after measurements taking]

Вторичные конечные точки (1)

• Oral health-related quality of life (OHRQoL), assessed using standardized questionnaires. [Срок оценки: immediately after measurements taking]

Критерии участия

Критерии включения

• Adults aged 45-65 years.
• Fully edentulous or partially edentulous maxilla requiring full-arch rehabilitation.
• Sufficient maxillary bone volume to support at least four implants according to the All-on-X protocol.
• Systemically healthy patients with no contraindications to dental implant surgery (ASA I-II classification).
• Demonstrated ability to maintain adequate oral hygiene
• Willingness to participate in the study and comply with follow-up visits and required maintenance protocols.
• Patients seeking a fixed, implant-supported prosthesis for the maxilla due to missing teeth and inability to use removable prostheses effectively.
• Acceptable radiographic findings with no signs of pathology, infection, or significant anatomical limitations.

Критерии исключения

• Uncontrolled systemic diseases (e.g., uncontrolled diabetes, osteoporosis, immunosuppressive disorders)
• History of radiation therapy to the head and neck region
• Active periodontal disease or untreated caries
• Maxillary cysts, tumors, or pathologies
• Poor oral hygiene or inability to maintain postoperative care
• Insufficient bone volume for All-on-X without extensive grafting
• Maxillary sinus pathology or oroantral fistula
• Psychiatric illness or cognitive impairment affecting compliance
• Bruxism or parafunctional habits
• Pregnant or lactating women
• History of implant failure or titanium allergy
• Use of bisphosphonates or antiresorptive medications
• Heavy smoking (>10 cigarettes/day)
• Inability or unwillingness to attend follow-up visits
• Diagnosed or symptomatic temporomandibular joint disorders (pain, clicking, locking, limited opening)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Египет · 1 центр

• October 6 University — Giza

Публикации

• Drancourt N, Auduc C, Mouget A, Mouminoux J, Auroy P, Veyrune JL, El Osta N, Nicolas E. Accuracy of Conventional and Digital Impressions for Full-Arch Implant-Supported Prostheses: An In Vitro Study. J Pers Med. 2023 May 15;13(5):832. doi: 10.3390/jpm13050832. PMID 37241002

Идентификаторы

NCT: NCT07550725 · RECO6u/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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