Additive Versus Subtractive Manufacturing for Endocrown Fabrication: A Clinical Comparison of 3D-Printed Ceramic-Filled Photopolymer Resin and CAD/CAM Milled Resin Nano-Ceramics Endocrowns in Posterior Teeth - A 24-Month Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Restoration Fracture Resistance
研究概览
简要总结
This randomized controlled trial (RCT) compares the 24-month clinical performance of endocrown restorations fabricated by two digital manufacturing pathways: additive manufacturing using 3D-printed ceramic-filled photopolymer resin (VarseoSmile TriniQ, BEGO) versus subtractive computer-aided design/computer-aided manufacturing (CAD/CAM) milling from hybrid nano-ceramic blocks (HC Hard Block, Shofu). Sixty endocrowns will be placed in endodontically treated posterior molars and evaluated using modified United States Public Health Service (USPHS) criteria at 6, 12, and 24 months. The trial is conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
详细描述
Post-endodontic rehabilitation of extensively damaged posterior molars using endocrowns represents a minimally invasive alternative to conventional crown-plus-post-and-core approaches. Digital fabrication has advanced both the precision and reproducibility of endocrown manufacture. While computer-aided design/computer-aided manufacturing (CAD/CAM) milled hybrid ceramic endocrowns are well-validated clinically, prospective clinical data comparing 3D-printed definitive restorations to milled counterparts are absent. This trial employs a parallel-group, 1:1 randomized design with triple blinding of participants, outcome assessors, and statistician. All restorations are delivered using Beautilink SA self-adhesive dual-cure resin cement. The primary outcome is fracture resistance at 24 months; secondary outcomes include retention, marginal adaptation, marginal discoloration, surface texture, anatomic form, color match, secondary caries, fabrication time, and patient satisfaction assessed by Visual Analogue Scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The treating clinician cannot be blinded due to visible differences between manufacturing workflows. Participants and outcome assessors are blinded to group allocation. The trial statistician is blinded to group assignment throughout analysis.
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25-45 years, male or female
- •Endodontically treated molar tooth with radiographically confirmed treatment success and no clinical signs of failure
- •Sufficient remaining coronal structure for endocrown preparation: minimum three walls, wall thickness 1.5 mm or greater, pulp chamber depth 3 mm or greater, supragingival preparation margins
- •Completely erupted tooth with intact periodontal support
- •Minimum of 20 occluding teeth
- •Satisfactory oral hygiene status
- •Capable of providing written informed consent and committed to scheduled follow-up visits
排除标准
- •Diagnosed parafunctional habit or nocturnal bruxism
- •Uncontrolled systemic illness or physical disability precluding safe participation
- •Heavy tobacco use
- •Current or suspected pregnancy
- •Periapical disease or radiographic signs of endodontic failure
- •Evidence of pathological tooth wear or occlusal erosion
- •Moderate-to-severe periodontitis or tooth with hopeless prognosis
- •Radiographic or clinical evidence of vertical root fracture
- •Impaired decision-making capacity or anticipated non-compliance
研究组 & 干预措施
CAD/CAM Milled Endocrown
Endocrown restoration fabricated by subtractive CAD/CAM milling from HC Hard Block hybrid nano-ceramic (Shofu Inc., Japan), designed using ExoCAD software and milled on a five-axis wet-milling unit. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan).
干预措施: CAD/CAM Milled HC Hard Block Endocrown (Device)
3D-Printed Endocrown
Endocrown restoration fabricated by additive manufacturing using VarseoSmile TriniQ ceramic-filled photopolymer resin (BEGO GmbH & Co. KG, Germany), printed on a 4K LCD printer at 30-45 degree build angle, post-cured under nitrogen atmosphere. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan).
干预措施: 3D-Printed VarseoSmile TriniQ Endocrown (Device)
结局指标
主要结局
Restoration Fracture Resistance
时间窗: 24 months
Assessed using modified USPHS criteria: Alpha = absence of fracture; Bravo = minor chip amenable to repair; Charlie = catastrophic fracture, unrestorable
次要结局
- Retention(6, 12, and 24 months)
- Marginal Discoloration(6, 12, and 24 months)
- Surface Texture(6, 12, and 24 months)
- Anatomic Form(6, 12, and 24 months)
- Color Match(6, 12, and 24 months)
- Secondary Caries(6, 12, and 24 months)
- Fabrication Time(Periprocedural)
- Patient Satisfaction(6, 12, and 24 months)
研究者
Dina Ezz
Associate Professor of Conservative Dentistry
Cairo University