Evaluation of Composite Veneers Fabricated by 3D Printing and Milling Technologies

August 10, 2026 updated by: youssef alaa

Evaluation of Composite Veneers Fabricated by 3D Printing and Milling Technologies (Randomized Controlled Clinical Trial & In-Vitro Study)

The clinical study aimed to evaluate the clinical performance, color stability, and wear of indirect composite veneers produced using 3D printing and milling technologies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of fifty-six anterior indirect veneers will be fabricated using 3D printing and milling technologies. The veneers will be divided into two groups according to the technique of fabrication. Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego), and group II: 28 veneers will be done using milling technology (Cerasmart 270, GC). Veneer restorations will be fabricated checked, and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year. Moreover, color stability and surface wear of the restorations will be evaluated in each follow-up session.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of dentistry, Alexandria university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy adult patients aged 18 to 45 years.
  • Patients requiring veneer restorations due to discoloration, misalignment, tooth malformation or having irregular tooth shape that can be treated without full coverage.
  • Patients meeting the criteria for Class I or Class II veneers according to the LeSage veneer classification system.
  • Patients requiring veneers restorations on their bilateral maxillary anterior teeth.
  • The selected teeth should be vital with absence of clinical signs and symptoms of periapical pathology.
  • Patients having a normal occlusal relationship between upper and lower teeth (class I Angle classification).
  • Patients capable of tolerating rubber dam applications.
  • Patients willing to attend regular follow-up appointments.

Exclusion Criteria:

  • Bad oral hygiene (Oral Hygiene Index Simplified >3).
  • Non-vital teeth or endodontically treated teeth.
  • Severe periodontal disease.
  • Patients with para-functional habits (e.g., bruxism, attrition, wear facets).
  • Dentin exposure more than 20% of the prepared surface for veneer.
  • Prescence of smoking/vaping habits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego)
Other: Group I (n=28): were restored with VarseoSmile TriniQ, Bego
A total of fifty-six anterior indirect veneers will be fabricated using 3D printing and milling technologies. The veneers will be divided into two groups according to the technique of fabrication. Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego), and group II: 28 veneers will be done using milling technology (Cerasmart 270, GC). Veneer restorations will be fabricated checked, and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year. Moreover, color stability and surface wear of the restorations will be evaluated in each follow-up session.
Active Comparator: group II: 28 veneers will be done using milling technology (Cerasmart 270, GC)
Other: Group II (n=28): were restored with Cerasmart 270, GC
A total of fifty-six anterior indirect veneers will be fabricated using 3D printing and milling technologies. The veneers will be divided into two groups according to the technique of fabrication. Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego), and group II: 28 veneers will be done using milling technology (Cerasmart 270, GC). Veneer restorations will be fabricated checked, and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year. Moreover, color stability and surface wear of the restorations will be evaluated in each follow-up session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The functional properties of the examined veneer restorations
Time Frame: 1 year
All veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Functional properties: (F1) Fracture of material and retention. (F2) Marginal adaptation. (F3) Proximal contact point. (F4) Form and contour. (F5) Occlusion and wear. Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), score 3: Clinically satisfactory (CS), score 4: Clinically unsatisfactory (CU), score 5: Clinically poor (PO).
1 year
The biological properties of the examined veneer restorations
Time Frame: 1 year
All Veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, and 12 months, following the revised FDI evaluation criteria and scoring system, which indicates: Biological properties (B1) Caries at restoration margins. (B2) Dental hard tissue defects at the restoration margin. (B3) Postoperative hypersensitivity and pulpal status. Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).
1 year
The aesthetic properties of the examined veneers
Time Frame: 1 year
All veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Aesthetic properties: (A1) Surface luster and surface texture. (A2) Marginal staining. (A3) Color match. Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).
1 year
The color stability of the examined veneers
Time Frame: 1 year
All Veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months using the vita easy shade spectrophotometer. The CIEDE2000 formula will be used to measure the color change.
1 year
Wear resistance of the examined veneers
Time Frame: 1 year
All Veneers were scanned clinically using an intra oral scanner at 1 week (baseline) and subsequently at 3, 6, and 12 months. The different scans were compared to baseline scan to assess the volume loss and accordingly the wear resistant.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
youssef alaa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9262109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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