3-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal Adaptation
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Marginal and Internal adaptation assessed by SEM.Micro-tensile bond strength (μTBS) in MPa.Clinical performance using modified FDI criteria.
研究概览
简要总结
Study Protocol Background The use of partial coverage restorations had increased significantly as a conservative alternative to full-coverage crowns, particularly in cases where the coronal tooth structure was extensively damaged and insufficient dentin remained to support direct restorations. These restorations were designed to preserve sound tooth structure while reinforcing weakened teeth affected by caries or fracture. Depending on the extent of cuspal coverage, partial coverage restorations were classified into inlays, onlays, and overlays.
With the advancement of digital dentistry, computer-aided design and computer-aided manufacturing (CAD/CAM) technologies had become widely adopted, enabling the fabrication of restorations with improved precision, mechanical performance, and esthetics. Various restorative materials were introduced, including glass ceramics, polycrystalline ceramics, and resin-matrix ceramics (hybrid ceramics). Hybrid ceramics, such as Vita Enamic, combined a ceramic network reinforced by a polymer phase, providing enhanced mechanical properties and favorable clinical behavior.
More recently, additive manufacturing technologies such as 3D printing had been introduced for the fabrication of definitive single-tooth restorations. However, limited evidence was available regarding their long-term performance, particularly in comparison with subtractive CAD/CAM materials. Additionally, marginal adaptation and bond strength were critical factors influencing clinical success, as failures were often initiated at the tooth-restoration interface.
Therefore, this study was designed to evaluate and compare the clinical and laboratory performance of 3D printed restorations, milled CAD/CAM hybrid ceramics, and indirect resin composite onlays.
- Aim of the Study
The study aimed to evaluate and compare the following:
- The 2-year clinical performance of 3D printed, milled CAD/CAM hybrid ceramic, and indirect resin composite onlays.
- The marginal and internal adaptation of the tested restorative materials.
- The micro-tensile bond strength to dentin. - Clinical Part Summary A randomized controlled clinical trial was conducted following CONSORT guidelines. Patients were selected from the outpatient clinic of the Faculty of Dentistry, Mansoura University. Inclusion criteria required the presence of at least three posterior teeth with weakened cusps indicated for indirect onlay or overlay restorations, good oral hygiene, and healthy vital teeth with no symptoms. Patients with severe bruxism, systemic instability, or allergies to study materials were excluded.
Each patient provided informed consent prior to participation, and ethical approval was obtained from the institutional review board. A split-mouth design was used, and teeth were randomly assigned into three groups according to the restorative material.
Standardized tooth preparations were performed under local anesthesia using adhesive onlay preparation principles. Impressions were taken, and provisional restorations were placed. Final restorations were fabricated using either milling or 3D printing techniques depending on the material type. All restorations were cemented using resin cement following manufacturer instructions under rubber dam isolation.
Clinical evaluation was performed at baseline, 1 month, 6 months, 12 months, 18 months, and 24 months using modified FDI criteria, assessing aesthetic, functional, and biological properties.
- Laboratory Part Summary For the in vitro component, 60 freshly extracted human molars were collected from patients attending the Faculty of Dentistry, Mansoura University. Teeth were cleaned, disinfected, and stored appropriately until use. Teeth with cracks, caries, or structural defects were excluded under stereomicroscopic examination.
Standardized Class II onlay preparations were performed on all specimens using a uniform protocol. Impressions were taken, and restorations were fabricated indirectly in a dental laboratory according to manufacturers' guidelines. Specimens were randomly assigned into three groups corresponding to the tested materials.
Marginal and Internal Adaptation Marginal adaptation was evaluated using epoxy resin replicas examined under scanning electron microscopy (SEM). Internal adaptation was assessed after sectioning the specimens longitudinally through the restoration axis. Gold sputter-coated samples were analyzed under SEM to measure internal gaps and adaptation quality.
Micro-tensile Bond Strength Test Restored teeth were sectioned into small beams with a cross-sectional area of approximately 1 mm². Each specimen was tested using a universal testing machine at a crosshead speed of 0.5 mm/min until failure occurred. Micro-tensile bond strength values were calculated by dividing the failure load by the bonded surface area.
- Statistical Analysis Data were recorded and analyzed using statistical software.
详细描述
The study was conducted as a combined clinical and laboratory investigation to evaluate and compare the performance of three restorative materials: 3D printed CAD/CAM hybrid resin, milled CAD/CAM hybrid ceramic, and indirect resin composite onlays. The clinical component followed a randomized controlled split-mouth design in accordance with CONSORT guidelines, while the laboratory component was designed as an in vitro experimental study.
- Clinical Part Patient Selection Patients were recruited from the Outpatient Clinic of the Faculty of Dentistry, Mansoura University. Eligible patients were selected based on predefined inclusion and exclusion criteria. Inclusion criteria required the presence of at least three posterior teeth with weakened cusps indicated for indirect onlay or overlay restorations, a stable occlusal relationship, permanent dentition, age above 18 years, good oral hygiene, and vital asymptomatic teeth with no sensitivity to percussion. The presence of antagonist teeth was also required.
Patients were excluded if they exhibited severe bruxism, uncontrolled systemic conditions, pregnancy or lactation, known allergies to restorative materials, or inability to attend recall visits.
All patients were informed about the purpose, procedures, and potential risks of the study, and written informed consent was obtained prior to participation. Ethical approval was granted by the Research Ethics Committee of the Faculty of Dentistry, Mansoura University.
- Randomization and Study Groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was applied due to the nature of the restorative interventions. Both the operator and the participants were aware of the type of restorative material used (3D printed CAD/CAM hybrid resin, milled CAD/CAM hybrid ceramic, and indirect resin composite onlays). Outcome assessment was performed by independent examiners.
入排标准
- 年龄范围
- 18 Months 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Patients aged 18 years or older with permanent dentition, presenting with at least three posterior teeth indicated for indirect onlay or overlay restorations, with favorable and stable occlusion. Patients should have good oral hygiene and vital, asymptomatic teeth with no sensitivity to percussion. Presence of antagonist teeth is required.
排除标准
- •Patients with severe bruxism, unstable medical conditions, or known allergy to any study materials. Patients unable to attend follow-up visits, pregnant or lactating females, and cases with pulp exposure during caries excavation are excluded.
研究组 & 干预措施
Clinical Evaluation of 3D-Printed Resin Composite, Milled Resin Composite, and Hybrid Ceramic Onlays
This study aims to clinically evaluate and compare the performance of three restorative materials: 3D-printed resin composite, milled resin composite, and hybrid ceramic used for onlays. A within-subject crossover design will be applied, where each participant receives all three materials under controlled clinical conditions. Outcomes such as clinical performance, adaptation, and survival will be assessed and compared within the same patient over the follow-up period.
干预措施: 3D printed CAD/CAM hybrid resin onlay.Milled CAD/CAM hybrid ceramic onlay (Vita Enamic)Indirect resin composite onlay. (Device)
结局指标
主要结局
Marginal and Internal adaptation assessed by SEM.Micro-tensile bond strength (μTBS) in MPa.Clinical performance using modified FDI criteria.
时间窗: 1. Marginal Adaptation Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months - 2. Micro-tensile Bond Strength Time Frame: Immediately after specimen preparation (in vitro) - 3. Clinical Performance (FDI Criteria) Time Frame: Baseline, 1 month,
Marginal and Internal adaptation was evaluated using scanning electron microscopy (SEM) by measuring the marginal gap between the restoration and tooth structure at standardized time intervals. Assessments were performed at baseline, 6, 12, 18, and 24 months. Micro-tensile bond strength was measured in megapascals (MPa) using a universal testing machine after sectioning restored teeth into beams with approximately 1 mm² cross-sectional area. Specimens were subjected to tensile loading until failure. Clinical performance was evaluated using modified FDI criteria assessing aesthetic, functional, and biological properties of restorations. Evaluations were performed at baseline, 1, 6, 12, 18, and 24 months by calibrated examiners-
次要结局
未报告次要终点
