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).
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.
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.
- Conditions
- Esthetics, Dental
- 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 group | Role | What they receive |
|---|---|---|
| Smilecloud Workflow | Experimental | Six 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 Workflow | Experimental | Six 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.
Mesiodistal widths of anterior teeth - Comparison between digital designs and fabricated restorations.
Measured: 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.
Measured: through study completion, an average of 1 year
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.
- First posted8 Oct 2025
- Study start5 Jun 2024
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esthetics, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Temporary Laminate Restorations Designed Using Two Different Digital Smile Design Workflows: A Pilot Study
- ClinicalTrials.gov ID
- NCT07213453
- Acronym / sponsor ID
- Marmara Prostho Murat Feriz
- Conditions
- Esthetics, Dental
- Keywords
- Digital dentistry, Laminate veneer restorations, Esthetics, Accuracy, Digital Smile Design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smilecloud Workflow | Experimental | Device: Digital Smile DesignSix laminate veneer restorations (canine-to-canine) designed via SmileCloud, beginning with 2D photographs and converted into 3D models before fabrication. |
| Smile Creator Workflow | Experimental | Device: Digital Smile DesignSix laminate veneer restorations (canine-to-canine) designed directly in 3D using Smile Creator with integration of intraoral scans and extraoral photographs. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 45 years
- Good general health
- Satisfactory periodontal condition
- Proper oral hygiene
- Dissatisfaction with anterior maxillary esthetics
Key exclusion criteria (5 listed)
- Active caries
- Untreated periodontal disease
- Missing teeth in the maxillary anterior region
- Severe malocclusion
- Poor oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Smile DesignDigital Smile Design workflows used for virtual planning and fabrication of laminate veneer restorations. | Device | Smile Creator Workflow, Smilecloud Workflow |
Primary outcome
Mesiodistal widths of anterior teeth - Comparison between digital designs and fabricated restorations.
Time frame: through study completion, an average of 1 year
2 secondary outcomes
Incisogingival lengths of central and lateral incisors - Comparison between digital designs and fabricated restorations.
Time frame: through study completion, an average of 1 year
Intercanine distance - Comparison between digital designs and fabricated restorations.
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Esthetics, Dental
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
AI-Assisted vs. Conventional Digital Smile Design for Laminate Veneers: A Prospective Crossover Study
Digital Dental Models
Not yet recruiting
Multicenter Clinical Study on the Efficacy and Esthetic Outcomes of Immediate Implant Placement Using the Socket-Shield Technique Versus Conventional Immediate Implantation in the Anterior Maxillary Esthetic Zone
Teeth Absent, Teeth Missing
Active, not recruiting
Enhancing Soft Tissues Around Inserted Implants by Two Different Methods
Missing Teeth
Not yet recruiting
Predictable Method for Restoring Endodontically Treated Teeth, Comparing Indirect and Direct Methods and Materials in Aesthetic Dentistry.
Endodontically Treated Teeth Requiring Indirect Restorative Treatment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.