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Идёт набор NCT07465978

Clinical Performance of Printed Hybrid Resin in Indirect Restorations

Без фазы С лечением Endodontically Treated Teeth Indirect Restoration

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: Indirect adhesive overlay restoration, Enamel Plus HRi, RelyX Universal, VarseoSmile TriniQ (3D-printed hybrid resin).
Кому может быть актуально
Состояния в реестре: Endodontically Treated Teeth, Indirect Restoration. Базовые параметры: от 18 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Clinical Behavior of 3D-Printed VarseoSmile TriniQ Resin Versus CAD/CAM Cerasmart in Indirect Restorations for Endodontically Treated Teeth: A Randomized Clinical Trial

Обзор

This randomized clinical trial aims to evaluate the clinical performance of a 3D-printed hybrid resin (VarseoSmile TriniQ) used for indirect restorations in endodontically treated teeth, compared with a CAD/CAM composite block (Cerasmart). In addition, two different luting protocols will be compared: a preheated microhybrid composite (Enamel Plus HRi) and a resin cement (RelyX Universal). Sixty patients requiring restoration of an endodontically treated molar with an indirect adhesive overlay will be recruited at the University Dental Clinic of the Universitat Internacional de Catalunya (Barcelona, Spain). Participants will be randomly assigned to receive restorations fabricated either using the printed hybrid resin or the CAD/CAM composite material. Each material group will be further divided according to the cementation technique used. All restorations will be fabricated following a digital workflow that includes intraoral scanning, CAD design, and either additive manufacturing (3D printing) or subtractive milling. Adhesive luting procedures will be performed according to standardized clinical protocols. Clinical evaluations will be performed at baseline, 3 months, 6 months, and 12 months, and annually thereafter. The clinical performance of the restorations will be assessed using modified United States Public Health Service (USPHS) criteria, including parameters such as marginal adaptation, contact points, color stability, wear, fracture occurrence, secondary caries, and patient comfort. The results of this study will provide clinical evidence regarding the behavior of 3D-printed hybrid resin restorations and their potential use as an alternative to conventional CAD/CAM composite materials for indirect restorations in endodontically treated teeth.

Подробное описание

Digital dentistry has significantly evolved over recent decades with the development of computer-aided design and computer-aided manufacturing (CAD/CAM) technologies. These digital workflows allow the design and fabrication of indirect restorations with high precision and efficiency. Traditionally, most CAD/CAM restorations have been produced using subtractive manufacturing techniques such as milling. However, additive manufacturing through three-dimensional printing is increasingly being introduced in dentistry and may offer advantages such as reduced material waste, lower manufacturing costs, and the ability to fabricate complex geometries.

Recently, a hybrid ceramic-filled resin specifically designed for additive manufacturing of definitive restorations has been introduced (VarseoSmile TriniQ, BEGO, Bremen, Germany). This material consists of a resin matrix filled with ceramic particles and is indicated for permanent restorations including crowns, inlays, onlays, and veneers. Although promising, clinical evidence regarding the performance of this printed hybrid material is still limited.

Composite CAD/CAM blocks such as Cerasmart (GC, Tokyo, Japan) are widely used for indirect restorations due to their favorable mechanical properties, wear resistance, and reparability. These materials combine characteristics of ceramics and composites and have demonstrated good clinical performance in previous studies. However, it remains unclear whether the newer printed hybrid materials provide comparable clinical outcomes.

Another important factor influencing the longevity of indirect restorations is the luting procedure. Preheated restorative composite resins have been proposed as an alternative to traditional resin cements for adhesive luting of indirect restorations. This technique may improve mechanical properties and reduce marginal gaps, but clinical evidence comparing these approaches remains limited.

The aim of this randomized clinical trial is therefore to evaluate the clinical behavior of indirect overlay restorations fabricated with a 3D-printed hybrid resin (VarseoSmile TriniQ) compared with restorations fabricated from a CAD/CAM composite block (Cerasmart). Additionally, two cementation strategies will be evaluated: a preheated microhybrid composite resin (Enamel Plus HRi) and a resin cement (RelyX Universal).

A total of 60 patients requiring restoration of an endodontically treated molar with an indirect overlay will be recruited at the University Dental Clinic of the Universitat Internacional de Catalunya (Barcelona, Spain). Participants will be randomly allocated into four groups according to the restorative material and cementation protocol used.

All teeth will receive standardized preparation procedures for adhesive indirect overlays, including immediate dentin sealing when indicated. Restorations will be designed using CAD software and fabricated either by additive manufacturing (3D printing) or subtractive milling. Adhesive luting will be performed following standardized protocols using rubber dam isolation.

Clinical evaluations will be performed at baseline, 3 months, 6 months, and 12 months, and annually thereafter. Outcomes will be assessed using modified United States Public Health Service (USPHS) criteria. The evaluated parameters will include marginal adaptation, contact points, color stability, polishability, wear, fracture occurrence, secondary caries, and patient comfort.

The results of this study are expected to provide new clinical evidence regarding the performance of 3D-printed hybrid resin restorations and the influence of different luting protocols in indirect restorations of endodontically treated teeth.

Вмешательства

  • Процедура Indirect adhesive overlay restoration
    Indirect overlay restoration performed on endodontically treated molars following a standardized digital workflow including tooth preparation, intraoral scanning, CAD design, and fabrication using either a 3D-printed hybrid resin (VarseoSmile TriniQ) or a CAD/CAM composite block (Cerasmart). Adhesive cementation is performed under rubber dam isolation.
  • Устройство Enamel Plus HRi
    Preheated microhybrid composite resin used as a luting material for indirect restorations. The composite is preheated to improve flowability and used as an adhesive luting agent following a standardized clinical protocol.
  • Устройство RelyX Universal
    Resin cement used for adhesive luting of indirect restorations according to the manufacturer's instructions and standardized clinical protocol.
  • Устройство VarseoSmile TriniQ (3D-printed hybrid resin)
    Definitive indirect overlay fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ (BEGO) following manufacturer-recommended printing and post-curing procedures.
  • Устройство Cerasmart (CAD/CAM composite block)
    Definitive indirect overlay fabricated from the CAD/CAM resin-composite block Cerasmart (GC) using a standardized milling and finishing protocol.

Первичные конечные точки

  • Clinical success of indirect overlay restorations [Срок оценки: Baseline, 3 months, 6 months, and 12 months after restoration placement.]
Вторичные конечные точки (8)
  • Marginal adaptation of the restoration [Срок оценки: Baseline, 3 months, 6 months, and 12 months after restoration placement.]
  • Proximal contact stability [Срок оценки: Baseline, 3 months, 6 months, and 12 months after restoration placement.]
  • Color stability of the restoration [Срок оценки: Baseline, 3 months, 6 months, and 12 months after restoration placement.]
  • Wear of the restoration [Срок оценки: Baseline, 3 months, 6 months, and 12 months after restoration placement.]
  • Restoration fracture or chipping [Срок оценки: Baseline, 3 months, 6 months, and 12 months after restoration placement.]
  • Secondary caries adjacent to the restoration [Срок оценки: Baseline, 3 months, 6 months, and 12 months after restoration placement.]
  • Patient-reported comfort with the restoration [Срок оценки: Baseline, 3 months, 6 months, and 12 months after restoration placement.]
  • Restoration survival [Срок оценки: From restoration placement to 12 months after placement.]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Signed informed consent
  • Need to restore an endodontically treated molar with an indirect adhesive overlay
  • Physically and psychologically able to tolerate conventional restorative procedures
  • No high caries risk
  • No active periodontal disease
  • Natural antagonist tooth present
  • Need for full cuspal coverage restoration (overlay)
  • Remaining wall thickness <3 mm in the endodontically treated tooth
  • Occlusal thickness of the restoration ≥1 mm
  • Willing and able to attend follow-up visits

Критерии исключения

  • Poor oral hygiene
  • Uncontrolled parafunctional habits (e.g., bruxism)
  • High caries risk
  • Active periodontal disease
  • Active pulpal disease
  • Absence of natural antagonist tooth
  • Need for partial cuspal coverage restoration (inlay or onlay)
  • Insufficient interarch space for restoration
  • Teeth planned as abutments for removable or fixed prostheses
  • Known allergy to any materials used in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Clínica Universitària d'Odontologia UIC Barcelona — Sant Cugat del Vallès

Идентификаторы

NCT: NCT07465978 · REST-ECL-2024-06

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗