Permanent Resin Restorations Fabricated by Three Dimension Printer

Evaluation of Clinical Performance of Permanent Resin Restorations Fabricated by 3D Printer

Additive manufacturing (AM) and 3D printing (3DP) technologies have advanced significantly in many different areas. With the time and cost advantage it provides in low-volume production, 3D printing technologies also come to the fore in the field of digital dentistry. A tooth-coloured, ceramic-filled permanent resin has been introduced by the manufacturer for the 3D fabrication of permanent single crowns, veneers, inlays and onlays. The aim of this clinical study was to clinically evaluate the long-term survival and intraoral performance of 3D-printed permanent resin. to the ICDAS caries classification system, 20 volunteers between the ages of 18-65 with class II caries lesion at D1 or D2 level were included in this study. Restorations were checked 1 week (baseline) and 6 months after completion and scored using the Modified Ryge Criteria (USPHS2(United States Public Health Service)). Statistical analysis was done by Kaplan-Meier survival analysis.

Study Overview

• Status: Recruiting
• Conditions: Three-Dimensional Printing, Computer-Aided Design, Dental
• Intervention / Treatment: Other: Formlabs Permanent CB Resin

Detailed Description

The design and manufacture of 3D printed restorations relies on the exchange of digital information (data) between 3D imaging, 3D virtual planning and/or 3D printing technologies. One of the key points in the widespread use of 3D printers is the emergence of these systems that allow data from different sources to be used in a personal computer with various design and production technologies. It saves Digital Imaging and Communication in Medicine (DICOM) files in STL format. STL files can be printed and processed with various CAD/CAM systems in local manufacturing or remote labs. This is an important advantage of using open source. With these systems, it is possible to produce restorations with clearer anatomical features thanks to current 3D printing technologies. In other words, low-cost restorations with more useful properties can be produced.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sarıcam
    • Adana, Sarıcam, Turkey, 01120
      • Recruiting
      • Cukurova University, Faculty of Dentistry, Department of Restorative Dentistry
      • Contact: zeliha G bek kurklu, PhD; Phone Number: 05334500892; Email: goncabek@mynet.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• premolar and/or molar tooth has class II caries lesion at D1 or D2 level according to ICDAS caries classification system.

Exclusion Criteria:

• bad oral hygiene
• bruxism,
• malocclusion,
• dry mouth,
• periodontal disease,
• teeth with restoration,
• periodontal or periapical pathology non-opposite and/or non-contact teeth will not be included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Permanent Resin 1 week; 1st week control	Other: Formlabs Permanent CB Resin; Tooth-colored, ceramic-filled permanent resin that can be fabricated with a 3D printer
Experimental: Permanent Resin 6 mouth; 6th month control	Other: Formlabs Permanent CB Resin; Tooth-colored, ceramic-filled permanent resin that can be fabricated with a 3D printer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 week follow up	Restorations will be scored 1 week after it is cemented onto the tooth using the Modified Ryge Criteria (USPHS2(United States Public Health Services))	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 mouths follow up	Restorations will be scored 6 mouths after it is cemented onto the tooth using the Modified Ryge Criteria (USPHS2(United States Public Health Services))	6 mouths

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: cu scientific research unit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No