NCT07522671

Clinical Performance of 3D-Printed Resin and Zirconia Implant Restorations

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prosthesis User

Interventions

Type	Name	Description
DEVICE	3D-Printed Resin Restoration (CROWNTEC)	Implant-supported single crowns or short-span fixed partial dentures fabricated using 3D-printed permanent resin (CROWNTEC). Restorations are produced using a standardized digital workflow, including intraoral scanning, CAD design, 3D printing at 50 µm layer thickness, post-processing (isopropyl alcohol cleaning, post-curing), finishing, and polishing. Restorations are delivered as screw- or cement-retained prostheses. In addition, Other 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 delive

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2028-11-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Egypt