Clinical Performance of 3D-Printed Resin Versus Milled Monolithic Zirconia in Implant-Supported Single Crowns and Short-Span Fixed Partial Dentures: A Randomized Controlled 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
- Restoration Survival Rate
研究概览
简要总结
This randomized controlled clinical trial evaluates the clinical performance of 3D-printed resin restorations compared with milled monolithic zirconia in implant-supported single crowns and short-span fixed partial dentures (FPDs). A total of patients requiring one or two implant-supported restorations in the mandibular anterior region were randomly allocated to receive either 3D-printed permanent resin restorations (CROWNTEC) or conventionally milled zirconia prostheses.
All restorations were fabricated using a standardized digital workflow and assessed over a 12-month follow-up period. The primary outcome was restoration survival rate, while secondary outcomes included technical complications, peri-implant biological parameters, marginal bone level changes, and patient-reported satisfaction.
This study aims to provide clinical evidence regarding the viability of 3D-printed definitive resin materials as an alternative to zirconia in implant prosthodontics.
详细描述
This study was designed as a parallel-arm randomized controlled clinical trial to compare the clinical performance of implant-supported restorations fabricated using a novel 3D-printed resin material (CROWNTEC) with that of conventionally milled monolithic zirconia. The investigation focused on single crowns and short-span fixed partial dentures (FPDs) in the mandibular anterior region, where functional and esthetic demands are critical.
Participants meeting predefined inclusion criteria were randomly assigned into two intervention groups: a 3D-printed resin group and a zirconia group. All restorations were produced using a fully digital workflow, including intraoral scanning, CAD design, and standardized manufacturing protocols. Prostheses were delivered as either screw-retained or cement-retained restorations, with careful control of occlusion and prosthetic design parameters.
Patients were followed at baseline, 3, 6, and 12 months, with extended follow-up planned up to 24 months. The primary outcome measure was restoration survival, defined as the absence of failure requiring replacement. Secondary outcomes included technical complications such as fracture, chipping, and screw loosening; biological parameters including plaque index, bleeding on probing, and probing depth; and radiographic assessment of marginal bone level changes. Patient-reported outcomes were also evaluated using a visual analog scale to assess satisfaction with esthetics, comfort, and masticatory function.
By directly comparing a novel additive manufacturing material with an established reference standard, this study addresses a critical gap in the literature regarding the clinical applicability of 3D-printed definitive restorations in implant dentistry. The findings are expected to contribute valuable evidence on the performance, limitations, and potential role of 3D-printed resin materials in modern prosthodontic practice.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following:
- •Age ≥18 years.
- •Have one or two osseointegrated dental implants requiring prosthetic restoration.
- •Demonstrate stable peri-implant tissues with no signs of inflammation or implant mobility.
- •Maintain good oral hygiene and controlled periodontal status.
- •Require either:
- •A single implant-supported crown, or
- •A short-span (maximum 3-unit) implant-supported fixed partial denture (FPD) supported by two implants in the mandibular anterior region.
排除标准
- •Participants are excluded if they have any of the following:
- •Severe parafunctional habits (e.g., bruxism).
- •Uncontrolled systemic diseases affecting bone metabolism or healing.
- •Peri-implantitis or compromised implant stability.
- •Requirement for cantilever prostheses or long-span restorations, or FPDs in areas other than the mandibular anterior region.
研究组 & 干预措施
3D-Printed Resin Restoration
Participants will receive implant-supported single crowns or short-span fixed partial dentures fabricated using 3D-printed permanent resin (CROWNTEC). Restorations are produced via a fully digital workflow, including intraoral scanning, CAD design, 3D printing, post-processing, and finishing, and delivered as screw- or cement-retained prostheses.
干预措施: 3D-Printed Resin Restoration (CROWNTEC) (Device)
Milled Zirconia Restorations
Participants will receive implant-supported single crowns or short-span fixed partial dentures fabricated from monolithic zirconia using CAD-CAM milling. Restorations undergo sintering, finishing, and polishing, and are delivered as screw- or cement-retained prostheses.
干预措施: 3D-Printed Resin Restoration (CROWNTEC) (Device)
结局指标
主要结局
Restoration Survival Rate
时间窗: 12 months
The proportion of implant-supported single crowns and short-span fixed partial dentures that remain functional without fracture, loss, or need for replacement over the follow-up period. Survival is defined as the restoration remaining in situ, fully functional, and free of catastrophic failure requiring intervention.
次要结局
未报告次要终点
研究者
Mohammed El-Sawy
Clinical Professor and principle investigator
Menoufia University