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Permanent Resin Restorations Fabricated by Three Dimension Printer

NCT ID: NCT05168852

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Three-Dimensional Printing, Computer-Aided Design, Dental

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Permanent Resin 1 week

1st week control

Group Type EXPERIMENTAL

Formlabs Permanent CB Resin

Intervention Type OTHER

Tooth-colored, ceramic-filled permanent resin that can be fabricated with a 3D printer

Permanent Resin 6 mouth

6th month control

Group Type EXPERIMENTAL

Formlabs Permanent CB Resin

Intervention Type OTHER

Tooth-colored, ceramic-filled permanent resin that can be fabricated with a 3D printer

Interventions

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Formlabs Permanent CB Resin

Tooth-colored, ceramic-filled permanent resin that can be fabricated with a 3D printer

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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zeliha gonca bek kurklu

department of dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cukurova University, Faculty of Dentistry, Department of Restorative Dentistry

Adana, Sarıcam, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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zeliha G bek kurklu, PhD

Role: primary

Other Identifiers

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cu scientific research unit

Identifier Type: -

Identifier Source: org_study_id