Clinical Behavior of 3D-Printed VarseoSmile TriniQ Resin Versus CAD/CAM Cerasmart in Indirect Restorations for Endodontically Treated Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical success of indirect overlay restorations
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical evaluator responsible for assessing the outcomes will be blinded to the restorative material and luting protocol used. Due to the nature of the interventions, operators performing the procedures cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VarseoSmile TriniQ + Enamel Plus HRi
Indirect overlay restoration fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ and adhesively luted using a preheated microhybrid composite (Enamel Plus HRi) following a standardized clinical protocol.
干预措施: Indirect adhesive overlay restoration (Procedure)
VarseoSmile TriniQ + Enamel Plus HRi
Indirect overlay restoration fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ and adhesively luted using a preheated microhybrid composite (Enamel Plus HRi) following a standardized clinical protocol.
干预措施: Enamel Plus HRi (Device)
VarseoSmile TriniQ + Enamel Plus HRi
Indirect overlay restoration fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ and adhesively luted using a preheated microhybrid composite (Enamel Plus HRi) following a standardized clinical protocol.
干预措施: VarseoSmile TriniQ (3D-printed hybrid resin) (Device)
VarseoSmile TriniQ + RelyX Universal
Indirect overlay restoration fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol.
干预措施: Indirect adhesive overlay restoration (Procedure)
VarseoSmile TriniQ + RelyX Universal
Indirect overlay restoration fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol.
干预措施: RelyX Universal (Device)
VarseoSmile TriniQ + RelyX Universal
Indirect overlay restoration fabricated using the 3D-printed hybrid resin VarseoSmile TriniQ and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol.
干预措施: VarseoSmile TriniQ (3D-printed hybrid resin) (Device)
Cerasmart + Enamel Plus HRi
Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using a preheated microhybrid composite (Enamel Plus HRi) following a standardized clinical protocol.
干预措施: Indirect adhesive overlay restoration (Procedure)
Cerasmart + Enamel Plus HRi
Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using a preheated microhybrid composite (Enamel Plus HRi) following a standardized clinical protocol.
干预措施: Enamel Plus HRi (Device)
Cerasmart + Enamel Plus HRi
Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using a preheated microhybrid composite (Enamel Plus HRi) following a standardized clinical protocol.
干预措施: Cerasmart (CAD/CAM composite block) (Device)
Cerasmart + RelyX Universal
Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol.
干预措施: Indirect adhesive overlay restoration (Procedure)
Cerasmart + RelyX Universal
Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol.
干预措施: RelyX Universal (Device)
Cerasmart + RelyX Universal
Indirect overlay restoration fabricated using the CAD/CAM composite block Cerasmart and adhesively luted using the resin cement RelyX Universal following a standardized clinical protocol.
干预措施: Cerasmart (CAD/CAM composite block) (Device)
结局指标
主要结局
Clinical success of indirect overlay restorations
时间窗: Baseline, 3 months, 6 months, and 12 months after restoration placement.
Clinical success of indirect overlay restorations placed on endodontically treated molars assessed using the modified United States Public Health Service (USPHS) criteria. Each restoration will be evaluated for marginal adaptation, contact points, color stability, wear, fracture, and secondary caries. USPHS scores are classified as Alpha (ideal clinical condition), Bravo (clinically acceptable), or Charlie (clinically unacceptable requiring replacement). Comparisons will be performed between restorative materials (3D-printed hybrid resin VarseoSmile TriniQ and CAD/CAM composite Cerasmart) and between luting protocols (preheated microhybrid composite Enamel Plus HRi and resin cement RelyX Universal).
次要结局
- Proximal contact stability(Baseline, 3 months, 6 months, and 12 months after restoration placement.)
- Color stability of the restoration(Baseline, 3 months, 6 months, and 12 months after restoration placement.)
- Wear of the restoration(Baseline, 3 months, 6 months, and 12 months after restoration placement.)
- Marginal adaptation of the restoration(Baseline, 3 months, 6 months, and 12 months after restoration placement.)
- Restoration fracture or chipping(Baseline, 3 months, 6 months, and 12 months after restoration placement.)
- Secondary caries adjacent to the restoration(Baseline, 3 months, 6 months, and 12 months after restoration placement.)
- Patient-reported comfort with the restoration(Baseline, 3 months, 6 months, and 12 months after restoration placement.)
- Restoration survival(From restoration placement to 12 months after placement.)
研究者
Marta Vallés Rodríguez
DDS, phD
Universitat Internacional de Catalunya