NCT07213453

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 5, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
Last Updated

October 8, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

September 22, 2025

Last Update Submit

October 1, 2025

Conditions

Keywords

Digital dentistryLaminate veneer restorationsEstheticsAccuracyDigital Smile Design

Outcome Measures

Primary Outcomes (1)

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

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Incisogingival lengths of central and lateral incisors - Comparison between digital designs and fabricated restorations.

    through study completion, an average of 1 year

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

    through study completion, an average of 1 year

Study Arms (2)

Smilecloud Workflow

EXPERIMENTAL

Six laminate veneer restorations (canine-to-canine) designed via SmileCloud, beginning with 2D photographs and converted into 3D models before fabrication.

Device: Digital Smile Design

Smile Creator Workflow

EXPERIMENTAL

Six laminate veneer restorations (canine-to-canine) designed directly in 3D using Smile Creator with integration of intraoral scans and extraoral photographs.

Device: Digital Smile Design

Interventions

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

Smile Creator WorkflowSmilecloud Workflow

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

October 8, 2025

Study Start

June 5, 2024

Primary Completion

September 5, 2025

Study Completion

September 5, 2025

Last Updated

October 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations