Clinical Performance of CAD/CAM-Milled Versus 3D-Printed Composite Resin Partial-Coverage Restorations for Endodontically Treated Molars: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Clinical performance of onlay and overlay restorations according to revised World Dental Federation (FDI) criteria.
研究概览
简要总结
The goal of this clinical trial is to compare the clinical performance of Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM)-milled and 3D-printed composite resin partial-coverage restorations in endodontically treated molars.
The main questions it aims to answer are:
- Do 3D-printed composite resin partial-coverage restorations show similar clinical performance compared with CAD/CAM-milled composite resin restorations?
- Are there differences in survival, success rates, and complications between the two types of restorations over a 3-year follow-up period?
Researchers will compare CAD/CAM-milled composite resin restorations with 3D-printed composite resin restorations to evaluate their clinical performance.
Participants will:
- Receive a partial-coverage restoration (onlay or overlay) in an endodontically treated molar.
- Be randomly assigned to receive either a CAD/CAM-milled or a 3D-printed composite resin restoration.
- Attend follow-up visits at 12, 24, and 36 months.
- Undergo clinical evaluations by two blinded evaluators using the revised FDI criteria and standardized photographic documentation.
详细描述
This randomized controlled clinical trial evaluates the clinical performance of indirect composite resin partial-coverage restorations fabricated using subtractive and additive manufacturing technologies in endodontically treated molars.
The study investigates whether 3D-printed composite resin restorations can achieve clinical outcomes comparable to CAD/CAM-milled composite resin restorations when used for cuspal coverage of structurally compromised posterior teeth.
All restorations will be fabricated using a fully digital workflow. Tooth preparation, immediate dentin sealing, digital intraoral scanning, restoration fabrication, and adhesive cementation procedures will be standardized and performed according to a predefined clinical protocol.
The trial will be conducted at Hospital San José, Santiago, Chile, using commercially available restorative materials manufactured by subtractive and additive technologies. Clinical performance will be evaluated according to internationally accepted restorative assessment criteria.
The study aims to generate medium-term clinical evidence regarding the use of 3D-printed composite resin restorations as a potential alternative to conventional CAD/CAM-milled restorations in restorative dentistry.
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
Participants and outcome assessors are blinded to treatment allocation. Two independent calibrated evaluators assess the restorations during follow-up visits. The treating clinician is not blinded because of the nature of the interventions. Allocation concealment is maintained through stratified block randomization using sequentially numbered opaque sealed envelopes.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70 years
- •Absence of active periodontal disease
- •Good oral hygiene (O'Leary plaque index <20%)
- •Absence of parafunctional habits (e.g., bruxism, onychophagia)
- •Endodontically treated first molars (maxillary or mandibular) with extensive Class II cavities and loss of at least one cusp, requiring onlay or overlay restoration
- •Tooth with functional occlusal contact and at least one proximal contact
- •Referred from the Endodontics Department of Hospital San José, with endodontic treatment completed at the same institution
- •Ability to provide written informed consent
- •Ability to attend follow-up visits at 12, 24, and 36 months
排除标准
- •Untreated active periodontal disease
- •Poor oral hygiene (O'Leary plaque index ≥20%)
- •Generalized active caries
- •Active parafunctional habits
- •Teeth with complete circumferential structural destruction or insufficient coronal tooth structure for onlay/overlay restoration
- •Subgingival margins compromising the biologic width
- •Known allergy to study materials
- •Pregnancy or breastfeeding
研究组 & 干预措施
Milled Composite Resin Onlay/Overlay
Participants receive indirect onlay or overlay restorations fabricated from milled composite resin blocks (HC Block, Shofu, Japan) for the rehabilitation of endodontically treated molars with extensive loss of tooth structure. Tooth preparation, immediate dentin sealing, digital impression, and adhesive cementation procedures are standardized for all participants
干预措施: Milled Composite Resin Onlay/Overlay Restoration (Device)
3D-Printed Composite Resin Onlay/Overlay
Participants receive indirect onlay or overlay restorations fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) for the rehabilitation of endodontically treated molars with extensive loss of tooth structure. Tooth preparation, immediate dentin sealing, digital impression, and adhesive cementation procedures are standardized for all participants.
干预措施: 3D-Printed Composite Resin Onlay/Overlay Restoration (Device)
结局指标
主要结局
Clinical performance of onlay and overlay restorations according to revised World Dental Federation (FDI) criteria.
时间窗: Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)
Clinical performance of milled and 3D-printed composite resin onlay and overlay restorations assessed using the revised FDI criteria. An overall FDI evaluation score will be assigned to each restoration by two blinded evaluators.
次要结局
- Restoration survival rate(36 months)
- Restoration success rate(36 months)
- Restoration failure rate(36 months)
- Clinical complications(Baseline to 36 months)
研究者
Tomás Yoma Galleguillos
Principal Investigator, Department of Dentistry, Hospital San Jose
Hospital San Jose