NCT04600297

3 Years Clinical Evaluation of 3D Printed Resin Composite Fixed Dental Prosthesis

Clinical Evaluation of 3D Printed Resin Composite Posterior Fixed Dental Prosthesis: A Prospective Clinical Trial up to 3 Years

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Istanbul Medipol University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In recent years there is a rapid increase in the use of computer aided design and production. Two main types of materials are used in the production of indirect CAD/CAM restorations namely resin composite based and ceramic ones. Mechanical properties and esthetics of ceramic materials are superior to resin composites but the advantages of intraoral repair, easy adjustments and polish of resin materials are undeniable. Improvements of mechanical properties of resin-based materials resulted in the development of resin composite blocks. 3D printed restorations, which can be performed as chairside in one session can be manufactured in case of any broken / chipping / debonding cases, without the need for repeated impression making. This saves time for the patient and the clinician. By using these 3D resin-based composite materials in fixed partial dentures, intraoral repairs can be performed. In addition, the high costs of burs and possible damage to the CAD/CAM blocks used in ceramic milling are eliminated when restoration are manufactured in printers with the DLP technology. The objective of this study was to evaluate the clinical outcome of 3D printed posterior resin composite FDP restorations up to 3 years.

Detailed description

The study will be carried out as a prospective study, with assessment of the restorations after three year. The project includes 3-unit posterior fixed dental prosthesis (FDP) for 70 cases. Patients participating in the investigation are going to be informed by the "Clinicians" on the background and risk of the investigation. Patients have to give their written consent to participate in the investigation. The treatment procedure includes the following steps: Preparation scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing and cementation of the FDP. The control procedures: Two weeks after cementation, baseline control will be performed according to USPHS and FDI 2. The restorations will be evaluated at 3 years recall.

Conditions

• Composite Resins
• Dental Prosthesis

Interventions

Type	Name	Description
DEVICE	ELS Even Stronger (3D Printed Resin Composite)	Missing of one premolar cases will be restored using the 3D Printed resin composite (ELS Even Stronger, Saremco, Switzerland). The steps of the procedure: Preparation, scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing, cementation.

Timeline

• Start date: 2020-10-10
• Primary completion: 2021-12-01
• Completion: 2024-03-01
• First posted: 2020-10-23
• Last updated: 2021-08-13

Locations

1 site across 1 country: Turkey (Türkiye)