Evaluation of Clinical Wear and Surface Roughness of Partial Restorations Produced by Additive and Subtractive Manufacturing Methods: A Split-Mouth Randomized Controlled Clinical Trial

NCT ID: NCT07057401

Last Updated: 2025-07-09

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2027-06-20

Brief Summary

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The aim of this study is to compare the surface roughness and wear values of crowns fabricated using currently utilized 3D printing and CAD-CAM technologies.

In recent years, crown restorations produced with CAD-CAM systems have been safely used in dentistry. These types of restorative materials are expected not to undergo significant wear themselves and also not to cause wear on natural teeth. Therefore, the structural resistance and hardness of the material are clinically very important. Restorations produced using 3D printing are among the latest technological developments in dentistry.

Additive manufacturing has been defined by the American Society for Testing and Materials (ASTM) as "the process of joining materials layer upon layer to make objects from 3D model data, as opposed to subtractive manufacturing methodologies."

3D printers have started to be used in various disciplines of dentistry such as dental education, oral surgery, dental implantology, orthodontics, pedodontics, prosthodontics, and restorative dentistry. In restorative clinics, they can especially be used in intracoronal restorations. However, studies in this area are quite limited.

The objective of this study is to evaluate the wear values using a Geomagic 3X device and the surface roughness values using a profilometer device over a 12-month period on single crown restorations applied to permanent first molars fabricated by CAD-CAM and 3D printing techniques.

A total of 26 single crown restorations will be performed on first molars. Participants will be selected among individuals aged 18-50 who apply to the Department of Restorative Dentistry, Faculty of Dentistry, Çukurova University. Eligible individuals must be systemically healthy, have no periodontal attachment loss, have an indication for crown restoration, and have a natural opposing tooth in contact with the restored tooth.

Detailed Description

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In today's dentistry, where aesthetics has gained increasing importance, the use of CAD-CAM in the fabrication of fixed prostheses has become widespread.

Although restorations produced by traditional methods are of high quality, they are mechanically and aesthetically affected due to being shaped manually by the dentist (conventional method). Therefore, errors that may occur during fabrication can negatively affect the durability and marginal adaptation of composite restorations.

In a study comparing production techniques, composite crowns produced by the direct technique and single crown restorations fabricated using CAD-CAM were examined under an electron microscope. The composite restorations manufactured with the indirect technique showed more porosity, while no porosity was observed in restorations produced with the CAD-CAM method.

This result may be attributed to the fact that the prefabricated CAD-CAM blocks are homogeneous and subjected to quality control during production. As a result, internal structural defects are generally not observed in milled products. The absence of porosity is an important factor in the durability and fit of restorations.

3D Printers Restorations produced using 3D printers are among the latest technological advancements in dentistry. Additive manufacturing has been defined by the American Society for Testing and Materials (ASTM) as "the process of joining materials layer upon layer to create objects from 3D model data, as opposed to subtractive manufacturing methodologies." 3D printers have begun to be used in various dental disciplines such as dental education, oral surgery, dental implantology, orthodontics, pedodontics, prosthodontics, and restorative dentistry. In restorative clinics, they can especially be utilized for intracoronal restorations. However, studies in this area remain quite limited.

Null hypothesis of this study is that there is no statistically significant difference in clinical wear and surface roughness between single crown indirect restorations fabricated using additive and subtractive manufacturing methods.

Conditions

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CAD/CAM Space Maintainer 3D Printing Dental Treatment Dental Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Evaluation of Wear and Surface Roughness of Partial Crowns Produced by Additive and Subtractive Manufacturing: A 1-Year Randomized Controlled Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
The aim of the study is to evaluate the wear values and surface roughness of single crown restorations performed on permanent molar teeth produced by CAD-CAM and 3D printing methods over a 12-month period using the Geomagic 3X device for wear measurement and a profilometer for roughness assessment.

Participants will be systemically healthy individuals aged 18 to 50 years, with no periodontal support loss, indicated for crown restoration, and having natural antagonist teeth, who apply to the Department of Restorative Dentistry Clinic at Çukurova University Faculty of Dentistry.

A total of 15 single crown restorations will be performed on first molar teeth.

Study Groups

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CAD-CAM Group

Participants will receive single crown restorations manufactured by subtractive manufacturing (CAD-CAM milling) techniques.

Group Type EXPERIMENTAL

CAD-CAM Manufactured Crowns

Intervention Type DEVICE

Single crowns produced using computer-aided design and milling technology applied to permanent molars.

3D Printing Group

Participants will receive single crown restorations manufactured by additive manufacturing (3D printing) techniques.

Group Type EXPERIMENTAL

3D Printed Crowns

Intervention Type DEVICE

Single crowns produced using 3D printing technology applied to permanent molars.

Interventions

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CAD-CAM Manufactured Crowns

Single crowns produced using computer-aided design and milling technology applied to permanent molars.

Intervention Type DEVICE

3D Printed Crowns

Single crowns produced using 3D printing technology applied to permanent molars.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Teeth with Devital and Vital Cusp Loss

Exclusion Criteria

* Root Canal Treated Teeth with Lesions
* Symptomatic Vital Teeth
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Husna Selinay

OTHER

Sponsor Role lead

Responsible Party

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Husna Selinay

Research Assistant Dentist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ezgi sonkaya akburak, doctor lecturer

Role: STUDY_DIRECTOR

Cukurova University Restorative Dentistry

Locations

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Çukurova Üniversitesi

Adana, sarıçam, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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HÜSNA SELİNAY S dağdelen, Research Assistant

Role: CONTACT

+905453051080 ext. 05453051080

Related Links

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Other Identifiers

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Department of Restorative Dent

Identifier Type: -

Identifier Source: org_study_id

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