Permanent Resin Restorations Fabricated by Three Dimension Printer

Sponsor

Cukurova University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05168852

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Three-Dimensional Printing, Computer-Aided Design, Dental	Other: Formlabs Permanent CB Resin	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

After the restorations are applied, the patients are checked in the 1st week and 6th months.After the restorations are applied, the patients are checked in the 1st week and 6th months.

Masking:

Single (Participant)

Masking Description:

Individuals aged 18-65 years with a D1 or D2 class II carious lesion

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

1 week follow up [1 week]
Restorations will be scored 1 week after it is cemented onto the tooth using the Modified Ryge Criteria (USPHS2(United States Public Health Services))

Secondary Outcome Measures

6 mouths follow up [6 mouths]
Restorations will be scored 6 mouths after it is cemented onto the tooth using the Modified Ryge Criteria (USPHS2(United States Public Health Services))

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova University, Faculty of Dentistry, Department of Restorative Dentistry	Adana	Sarıcam	Turkey	01120

Sponsors and Collaborators

Cukurova University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

zeliha gonca bek kurklu, department of dentistry, Cukurova University

ClinicalTrials.gov Identifier:

NCT05168852

Other Study ID Numbers:

cu scientific research unit

First Posted:

Dec 23, 2021

Last Update Posted:

Dec 23, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 23, 2021