Prosthetic Complications in Full-arch Screw-retained Implant Restorations Using Monolithic Zirconia Versus Titanium Frameworks: A Randomized Clinical Trial

Обзор

The goal of this clinical trial is to to compare the prosthetic complication rate and Oral Health-Related Quality of Life (OHRQoL) between screw-retained monolithic zirconia frameworks and CNC-milled titanium frameworks with zirconia superstructures in completely edentulous patients restored with full-arch implant-supported prostheses over a follow-up period of 12 months.

Вмешательства

• Другое Monolithic Zirconia Prosthesis
  Intervention: Screw-Retained Monolithic Zirconia Prosthesis * Components: The prosthesis is a one-piece, full-arch framework milled from a single, monolithic zirconia blank. It includes the infrastructure, prosthetic teeth, and gingival contours. The prosthesis is screw-retained directly to multi-unit abutments. The prosthesis is delivered on the day of final insertion and is intended to be a definitive, long-term restoration. * Procedure for Tailoring: The prosthesis is fully customized for ea
• Другое CNC-milled titanium framework and zirconia superstructure
  The prosthesis consists of two parts: A CNC-milled titanium framework, and a CNC-milled zirconia superstructure that is cemented onto the framework. The titanium framework is screw-retained directly to multi-unit abutments. The zirconia superstructure is permanently cemented to the framework with resin cement.

Первичные конечные точки

• Prosthetic complications [Срок оценки: 1 year]

Вторичные конечные точки (1)

• Oral Health-Related Quality of Life (OHRQoL) [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Aged 18 years or older.
• Able to understand the study procedures and provide written informed consent.
• In good general health, classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.
• Completely edentulous in the arch to be treated (maxilla and/or mandible).
• A candidate for a full-arch, screw-retained implant-supported prosthesis, requiring 4 to 6 implants in the treatment arch.
• Sufficient bone volume at planned implant sites to place implants of at least 3.5mm in diameter and 8mm in length.
• Adequate crown height space (15-22 mm) for a fixed prosthesis.
• A zone of keratinized mucosa at the crest of the ridge measuring at least 2 mm in width.
• Opposing arch is fixed full-arch implant-supported prosthesis.
• Demonstrates acceptable oral hygiene and the motivation to maintain it.

Критерии исключения

• Medical contraindications:

• Uncontrolled diabetes (HbA1c > 7.0%).
• History of radiotherapy in the head and neck region.
• History of intravenous bisphosphonate therapy.
• Immunosuppressed or immunocompromised status.
• Any other uncontrolled systemic disease that constitutes a contraindication for oral surgery.
• Behavioral Factors:

• Heavy smoking, defined as consumption of more than 10 cigarettes per day.
• Presence of parafunctional habits (e.g., bruxism, clenching) as diagnosed by clinical examination.
• Local Oral Factors:

• Active, untreated periodontal disease in any remaining dentition.
• Presence of acute oral infection or pathology at the intended surgical site.
• Crown height space less than 15 mm or more than 22 mm.
• Insufficient keratinized mucosa (< 2 mm width) that cannot be corrected with a simple surgical procedure prior to implant placement.
• General:

• Pregnancy or lactation.
• Participation in another interventional clinical trial.
• Perceived inability to comply with the study protocol and follow-up schedule.

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

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry - Cairo University — Cairo

Идентификаторы

NCT: NCT07657364 · 09062026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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