NCT07057401

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

June 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2027

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

June 3, 2025

Last Update Submit

July 4, 2025

Conditions

Keywords

subtractive manufacturing, additive manufacturing, roughness, wear

Outcome Measures

Primary Outcomes (2)

  • Wear

    Measuring wear value using the Geomagic 3X device

    12 months

  • Surface roughness

    Measuring surface roughness values using a profilometer device

    12 months

Study Arms (2)

CAD-CAM Group

EXPERIMENTAL

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

Device: CAD-CAM Manufactured Crowns

3D Printing Group

EXPERIMENTAL

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

Device: 3D Printed Crowns

Interventions

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

CAD-CAM Group

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

3D Printing Group

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teeth with Devital and Vital Cusp Loss

You may not qualify if:

  • Root Canal Treated Teeth with Lesions
  • Symptomatic Vital Teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova Üniversitesi

Adana, sarıçam, 01250, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

  • ezgi sonkaya akburak, doctor lecturer

    Cukurova University Restorative Dentistry

    STUDY DIRECTOR

Central Study Contacts

HÜSNA SELİNAY S dağdelen, Research Assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Evaluation of Wear and Surface Roughness of Partial Crowns Produced by Additive and Subtractive Manufacturing: A 1-Year Randomized Controlled Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant Dentist

Study Record Dates

First Submitted

June 3, 2025

First Posted

July 9, 2025

Study Start

September 20, 2025

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

June 20, 2027

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations