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

NCT07522671 | Recruiting

• 1 other identifier: ADMNF-00326
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prosthesis User

Outcome Measures

Primary Outcomes (1)

• Restoration Survival Rate

  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.

  12 months

Study Arms (2)

3D-Printed Resin Restoration

EXPERIMENTAL

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.

Device: 3D-Printed Resin Restoration (CROWNTEC)

Milled Zirconia Restorations

ACTIVE COMPARATOR

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.

Device: 3D-Printed Resin Restoration (CROWNTEC)

Interventions

3D-Printed Resin Restoration (CROWNTEC) DEVICE

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

Also known as: Milled Zirconia Restorations

3D-Printed Resin Restoration; Milled Zirconia Restorations

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Mohammed Elsawy

Shibīn al Kawm, 2266166, Egypt

RECRUITING

Central Study Contacts

Mohammed A. Elsawy, PhD

CONTACT

00201061314522; mohamed.elsawy@dent.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and principle investigator

Model Details: Parallel-group randomized clinical trial comparing 3D-printed resin and zirconia implant-supported restorations, with participants assigned to one intervention and followed over time.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

EG (1)