Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars
Clinical Performance of CAD/CAM-Milled Versus 3D-Printed Composite Resin Partial-Coverage Restorations for Endodontically Treated Molars: A Randomized Controlled Clinical Trial
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Tomás Yoma Galleguillos, DDS
- 电话号码：+56985768407
- 邮箱：tomasyoma@gmail.com
学习地点
-
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Santiago Metropolitan
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Santiago、Santiago Metropolitan、智利
- 招聘中
- Hospital San Jose
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接触：
- Tomás Yoma Galleguillos, DDS
- 电话号码：+56985768407
- 邮箱：tomasyoma@gmail.com
-
首席研究员：
- Tomás Yoma Galleguillos, DDS
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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
|
Indirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars.
|
|
实验性的：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.
|
Indirect partial coverage restoration fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical performance of onlay and overlay restorations according to revised World Dental Federation (FDI) criteria.
大体时间：Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)
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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.
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Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Restoration survival rate
大体时间：36 months
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Survival of milled and 3D-printed composite resin onlay and overlay restorations.
A restoration will be considered surviving if it remains in function at follow-up, regardless of the need for minor repair.
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36 months
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Restoration success rate
大体时间：36 months
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Success of restorations according to revised FDI criteria.
Restorations receiving clinically acceptable ratings and not requiring corrective intervention will be considered successful.
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36 months
|
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Restoration failure rate
大体时间：36 months
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Proportion of restorations requiring replacement during the 36-month follow-up period.
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36 months
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Clinical complications
大体时间：Baseline to 36 months
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Frequency and type of clinical complications observed during the 36-month follow-up period, including mechanical, biological, and esthetic complications associated with the restorations.
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Baseline to 36 months
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合作者和调查者
调查人员
- 首席研究员：Tomás Yoma Galleguillos, DDS、Hospital San José, Santiago, Chile
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- HSJ-RCT-3DPRINT-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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