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Esthetics, DentalNCT07213453

Accuracy of Temporary Laminate Restorations With Digital Workflows

A study testing Digital Smile Design in people with Esthetics, Dental, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot clinical study investigates the dimensional accuracy of temporary laminate veneer restorations designed using two distinct digital smile design (DSD) workflows. Five healthy volunteers with intact maxillary anterior dentition and good oral hygiene were enrolled at Marmara University, Faculty of Dentistry. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Esthetics, Dental
What is being tested?
Digital Smile Design
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Jun 2024to 5 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age between 18 and 45 years
  • Good general health
  • Satisfactory periodontal condition
  • Proper oral hygiene
  • Dissatisfaction with anterior maxillary esthetics
  • Presence of complete maxillary anterior dentition without extensive restorations or severe discoloration

Who cannot join

  • Active caries
  • Untreated periodontal disease
  • Missing teeth in the maxillary anterior region
  • Severe malocclusion
  • Poor oral hygiene

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Accuracy of Temporary Laminate Restorations Designed Using Two Different Digital Smile Design Workflows: A Pilot Study

This pilot clinical study investigates the dimensional accuracy of temporary laminate veneer restorations designed using two distinct digital smile design (DSD) workflows. Five healthy volunteers with intact maxillary anterior dentition and good oral hygiene were enrolled at Marmara University, Faculty of Dentistry. Two digital workflows were compared: (1) a 2D-to-3D transformation approach using SmileCloud, where extraoral photographs are initially used for two-dimensional planning before conversion to 3D models, and (2) a direct three-dimensional design workflow using Exocad Smile Creator, which integrates intraoral scans and extraoral photographs at the initial stage. A total of 60 provisional laminate veneers were virtually designed and fabricated using stereolithography (SLA) 3D printing technology with ceramic-based resin. Dimensional measurements of mesiodistal tooth widths, inciso-gingival lengths, and intercanine distances were obtained from both digital designs and printed restorations. Statistical analysis compared the accuracy of virtual-to-physical transfer in both workflows. The findings aim to provide preliminary evidence on the reliability of digital smile design approaches for esthetic treatment planning and fabrication of temporary restorations.

Read the detailed description

Aesthetic dentistry increasingly emphasizes minimally invasive procedures that integrate objective clinical standards with patients' esthetic expectations. Porcelain laminate veneers are one of the most widely accepted restorative approaches for enhancing smiles while preserving tooth structure. Provisional restorations play a central role in this process by offering a tangible preview of the anticipated outcome before irreversible treatment is performed. With the advancement of digital technologies, diagnostic mock-ups can now be generated virtually, converted into STL files, and fabricated with high precision using 3D printing. Within this context, digital smile design (DSD) has become a systematic tool that enhances communication, improves diagnostic accuracy, and supports predictable esthetic outcomes.

The present pilot study evaluates two distinct DSD workflows with the goal of assessing their dimensional accuracy in translating virtual designs into physical provisional restorations. Smilecloud initiates the planning process with two-dimensional photographic data. It automatically generates a smile frame based on facial references and provides a curated library of esthetic tooth shapes that can be customized. Once finalized, the 2D design is converted into a 3D model, which is later superimposed onto intraoral scans using dental CAD software. This workflow offers advantages for rapid case visualization and patient communication; however, its reliance on 2D projections may introduce errors in representing transverse dental relationships.

In contrast, Exocad Smile Creator employs a direct 3D workflow, integrating intraoral scans and extraoral photographs from the beginning. This enables precise alignment of dental arches with facial reference lines, allowing clinicians to make real-time adjustments. By eliminating intermediate data conversions, this approach is expected to minimize error propagation and provide greater dimensional fidelity.

Five volunteers aged 18-45 years with intact anterior dentition and good periodontal health were recruited. Standardized photographic records were obtained, and intraoral digital impressions were recorded with the 3Shape TRIOS 3 scanner. For each participant, six laminate veneer restorations were digitally designed in both workflows, resulting in a total of 60 provisional veneers.

All virtual designs were exported as STL files and fabricated with a stereolithography (SLA) 3D printer using a ceramic-based resin. Post-processing included rinsing in isopropyl alcohol, UV curing, and polishing. Dimensional measurements were performed both digitally and on fabricated restorations using a high-precision digital caliper. Parameters included mesiodistal tooth widths, inciso-gingival lengths, and intercanine arch width.

Statistical analysis assessed differences between virtual designs and physical restorations. Results indicated that vertical parameters showed no significant discrepancies across workflows. However, intercanine width was significantly underestimated in the 2D-based Smilecloud designs. Direct 3D workflows demonstrated close agreement between digital and physical outcomes.

This study demonstrates that both Smilecloud and Smile Creator can produce clinically acceptable provisional restorations, but dimensional fidelity is enhanced when a direct 3D workflow is used. The findings emphasize the importance of integrating intraoral scans early in the design stage to avoid errors in transverse dimensions. While limited by small sample size, this investigation provides foundational evidence for digital workflows and supports further research in larger populations.

Being tested
Digital Smile Design
Keywords
Digital dentistry, Laminate veneer restorations, Esthetics, Accuracy, Digital Smile Design

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Smile DesignDevice

    Digital Smile Design workflows used for virtual planning and fabrication of laminate veneer restorations.

Study groups in NCT07213453
Study groupRoleWhat they receive
Smilecloud WorkflowExperimentalSix laminate veneer restorations (canine-to-canine) designed via SmileCloud, beginning with 2D photographs and converted into 3D models before fabrication.
Receives: Device: Digital Smile Design
Smile Creator WorkflowExperimentalSix laminate veneer restorations (canine-to-canine) designed directly in 3D using Smile Creator with integration of intraoral scans and extraoral photographs.
Receives: Device: Digital Smile Design

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mesiodistal widths of anterior teeth - Comparison between digital designs and fabricated restorations.

    Measured: through study completion, an average of 1 year

Secondary outcomes (2)
  1. Incisogingival lengths of central and lateral incisors - Comparison between digital designs and fabricated restorations.

    Measured: through study completion, an average of 1 year

  2. Intercanine distance - Comparison between digital designs and fabricated restorations.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start5 Jun 2024
  3. Primary completion5 Sep 2025
  4. Study completion5 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07213453
Sponsor's protocol ID
Marmara Prostho Murat Feriz
Status last verified
Sep 2025
First submitted
22 Sep 2025
Last updated
8 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital Smile Design in people with Esthetics, Dental, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mesiodistal widths of anterior teeth - Comparison between digital designs and fabricated restorations. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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