Performance of CAD/CAM Milled and 3D-printed Full-arch Implant-supported Provisionals Restorations

Summary

This clinical trial aims to compare the performance of CAD/CAM-milled and 3D-printed full-arch implant-supported provisional restorations in patients at the Advanced Implant Prosthetics Clinic of the Complutense University of Madrid, of both sexes, over 18 years of age, edentulous upper, lower or both, whose treatment plan is at least a fixed implant-supported rehabilitation of the complete arch. The main question it aims to answer is if there are differences in the mechanical behavior and optical properties of the materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology through machining or 3D printing.

Participants will:

\- Receive milled (control material: PMMA; Multilayer PMMA block, HUGE; Shandong Huge Dental Material Corporation) or printed (test material: 3D impression resin; VarseoSmile Temp, Bego Bremer Goldschägerei Wilh. Herbst GmbH \& Co. KG, Bremen) and they will be in provisional phase for 3 months doing daily life.

Researchers will compare PMMA (Multilayer PMMA block, HUGE; Shandong Huge Dental Material Corporation) and the printed-resin (3D impression resin; VarseoSmile Temp, Bego Bremer Goldschägerei Wilh. Herbst GmbH \& Co. KG, Bremen) to see:

* Mechanical behavior and the absence of complications, fracture of the structure, material jumping or wear, loosening, or detachment.
* Optical properties, initial color, and degradation of the materials used

Conditions

• Edentulous Jaw
• Dental Prosthesis Complication
• Dental Prosthesis Failure

Interventions

DEVICE

3D- printed Full-arch Implant-supported Provisionals Restorations

The full-arch provisional restorations will be placed on dental implants that should be positioned to allow for the fabrication of a prosthesis that spans at least 12 units (from the right first molar to the left first molar, accepting distal extensions). Before completing the essential clinical data registration to produce an individual patient-oriented prosthesis, trans-epithelial abutments will be put at the torque the manufacturer recommends (30-35 Ncm typically), according to the appropriate gingival height. At visit three, the full-arch provisional will be screwed in using the manufacturer's specified torque (15 Ncm typically). For 12 to 15 weeks (about three months), the patient will be in the preliminary phase, during which time data will be gathered. Once the stipulated time has elapsed, the definitive prosthesis in monolithic zirconia prosthesis will be placed.

DEVICE

CAD/CAM-milled Full-arch Implant-supported Provisionals Restorations

The full-arch provisional restorations will be placed on dental implants that should be positioned to allow for the fabrication of a prosthesis that spans at least 12 units (from the right first molar to the left first molar, accepting distal extensions). Before completing the essential clinical data registration to produce an individual patient-oriented prosthesis, trans-epithelial abutments will be put at the torque the manufacturer recommends (30-35 Ncm typically), according to the appropriate gingival height. At visit three, the full-arch provisional will be screwed in using the manufacturer's specified torque (15 Ncm typically). For 12 to 15 weeks (about three months), the patient will be in the preliminary phase, during which time data will be gathered. Once the stipulated time has elapsed, the definitive prosthesis in monolithic zirconia prosthesis will be placed.

Sponsors & Collaborators

• Universidad Complutense de Madrid

  lead OTHER

Principal Investigators

• Miguel Gómez Polo, DDS, PhD · Universidad Complutense de Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2025-05-01

Completion

2025-07-30

Countries

• Spain

Study Locations