Digital Dental ModelsAI-DSDNCT07863895
AI-Assisted vs. Conventional Digital Smile Design for Laminate Veneers: A Prospective Crossover Study
A study testing mockup for laminate veneers using AI-assisted CAD software and mockup using conventional CAD software in people with Digital Dental Models, run by King Salman International university at 1 site in Egypt.
Trial summary
Background: Digital Smile Design (DSD) has become an important component of contemporary esthetic dentistry, allowing clinicians to visualize proposed treatment outcomes and improve communication with patients and dental technicians. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Digital Dental Models
- What is being tested?
- mockup for laminate veneers using AI-assisted CAD software and mockup using conventional CAD software
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2026to 25 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients aged ≥18 years old.
- Patients with teeth problems indicated for laminate veneers (e.g. discoloration, defect does not involve more than 60% enamel loss, mild malposition, spacing,
- ….).
- Patients with vital teeth with no periodontal diseases.
- Patients with good oral hygiene.
- Patients capable of understanding and giving informed consent.
Who cannot join
- Patients with severe malocclusion
- Patients with history of bruxism or parafunctional habits
- Patients with previous prosthodontic treatment in the anterior maxilla
- Patients who are Allergic to mock-up materials
- Pregnant women.
- Patients having no opposing dentition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AI-assisted Versus Conventional CAD Workflows in Digital Smile Design for Laminate Veneers: A Prospective Crossover Study of Esthetic and Patient-related Outcomes
Background:
Digital Smile Design (DSD) has become an important component of contemporary esthetic dentistry, allowing clinicians to visualize proposed treatment outcomes and improve communication with patients and dental technicians. Conventional computer-aided design (CAD) workflows, such as Exocad, provide individualized designs but require considerable operator expertise and time and may be influenced by operator-related variability. Artificial intelligence (AI)-assisted CAD systems have recently been introduced to automate parts of the design process and potentially improve efficiency, consistency, and esthetic predictability. However, direct clinical comparisons between AI-assisted and conventional CAD workflows for laminate veneer smile design remain limited.
Read more
Aim:
This prospective randomized crossover study aims to compare AI-assisted and conventional manual CAD workflows for digital smile design in patients indicated for maxillary anterior laminate veneers, focusing on patient-reported satisfaction, esthetic and functional design outcomes, and software efficiency.
Methods:
A total of 44 adult participants indicated for laminate veneer treatment were recruited from the Oral and Dental Diagnostic Center, Faculty of Dentistry, King Salman International University. The sample size includes allowance for an anticipated 20% attrition. Participants will be randomly allocated in a 1:1 ratio to one of two crossover sequences: AI-assisted CAD followed by conventional CAD, or conventional CAD followed by AI-assisted CAD. A washout period of at least 48 hours will separate the two mock-up evaluations.
Standardized DSD photographs and intraoral scans will be obtained for each participant. Two digital smile designs will then be produced: one using AI-assisted software and the other using the conventional manual Exocad Smile Creator workflow. Both designs for each case will be completed under standardized conditions to minimize operator-related variability. The resulting virtual designs will be 3D printed to fabricate silicone indices for intraoral mock-up trials. Participants will evaluate both mock-ups while remaining blinded to the design method.
Outcomes:
The primary outcome will be patient esthetic satisfaction with each mock-up, assessed using a Visual Analog Scale (VAS; 0-10). Secondary outcomes will include objective design-based esthetic parameters, including facial landmark and plane accuracy, tooth proportions, symmetry, gingival zenith symmetry, incisal edge position, midline alignment, and contour accuracy. Functional outcomes will include occlusal contacts, incisal guidance, and interproximal contact length. Software efficiency will also be assessed through design time and operator-rated ease of use. Three blinded prosthodontists will evaluate the esthetic and functional characteristics of the virtual designs.
Statistical Analysis and Ethics:
Data normality will be evaluated using the Shapiro-Wilk test, followed by appropriate parametric or non-parametric statistical analyses. The protocol reviewed by the Research Ethics Committee of the Faculty of Dentistry, King Salman International University. Written informed consent obtained from all participants, and collected data will be coded, securely stored, and treated confidentially.
Expected Significance:
The study is designed to provide evidence on whether AI-assisted CAD workflows differ from conventional CAD workflows in patient satisfaction, esthetic and functional design outcomes, and workflow efficiency. By integrating patient-centered intraoral mock-up evaluation with objective virtual-model assessment in a crossover design, the study may help inform the evidence-based incorporation of AI into digital workflows for laminate veneer treatment.
- Conditions
- Digital Dental Models
- Being tested
- mockup for laminate veneers using AI-assisted CAD software, mockup using conventional CAD software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mockup for laminate veneers using AI-assisted CAD softwareProcedure or surgery
It specifically evaluates whether AI-assisted design can provide comparable or different outcomes in terms of patient esthetic satisfaction, objective esthetic and functional design parameters, and workflow efficiency.
mockup using conventional CAD softwareProcedure or surgery
It specifically evaluates whether conventional exocad design can provide comparable or different outcomes in terms of patient esthetic satisfaction, objective esthetic and functional design parameters, and workflow efficiency.
| Study group | Role | What they receive |
|---|---|---|
| Digital smile design for laminate veneers using AI-assisted CAD software | Experimental | Not described Receives: Procedure: mockup for laminate veneers using AI-assisted CAD software |
| Digital smile design for laminate veneers using conventional CAD software | Experimental | Not described Receives: Procedure: mockup using conventional CAD software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic satisfaction for each mock up
Two virtual smile designs, one from each tested software will be 3D printed to create corresponding silicone indices for intraoral mock-up trials.
Each participant will test both mock-ups in a randomized sequence, with a brief washout period between trials.
After evaluating each mock-up, participants will complete a validated satisfaction questionnaire (using VAS) from 0 to 10 scores where 0 is the minimum score which represents totally dissatisfied while 10 is the maximum score which represents totally satisfied assessing:
Esthetic appeal Perceived naturalness of the smile Overall smile preference
Measured: 5 minutes
Secondary outcomes (3)
Esthetic Outcomes(Design-based Evaluation)
Esthetic outcomes will be assessed through design-based evaluation of facial analysis, tooth proportions, bilateral symmetry, gingival zenith symmetry, incisal edge position, midline alignment, and contour accuracy. Facial landmark and reference-plane deviations will be measured in millimeters (mm). Tooth proportions will be evaluated using width-to-length ratios. Bilateral and gingival zenith symmetry will be assessed from horizontal and/or vertical deviations between corresponding right and left landmarks and expressed as RMS discrepancies (mm). Incisal edge position will be measured relative to the incisal reference plane in mm. Midline alignment will be quantified as dental-to-facial midline deviation (mm). Finally, contour accuracy will be measured by superimposing the two digital designs and quantifying the three-dimensional discrepancy between their corresponding surfaces, with the overall deviation expressed as an RMS value in millimeters.
Measured: 1 hour
Functional outcomes (Design-based Evaluation)
Functional outcomes will be assessed through a design-based evaluation of interproximal contact length. Proximal contacts between adjacent teeth will be compared to determine differences in contact length between the evaluated designs, with discrepancies expressed in millimeters (mm).
Measured: 1 hour
Software efficiency
Software efficiency will be evaluated based on design time and ease of use. Design time will be recorded using a stopwatch from the start to the completion of the design process and expressed in minutes. Ease of use will be assessed by the operator using a 5-point Likert-scale survey, with scores ranging from 1 to 5 where 0 is the most difficult and 5 is the easiest.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start10 Jul 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Dental ModelsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Salman International university
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elgendi, King Salman International university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863895
- Sponsor's protocol ID
- maielgendi3092026
- Acronym
- AI-DSD
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-assisted Versus Conventional CAD Workflows in Digital Smile Design for Laminate Veneers: A Prospective Crossover Study of Esthetic and Patient-related Outcomes
- ClinicalTrials.gov ID
- NCT07863895
- Acronym / sponsor ID
- AI-DSD / maielgendi3092026
- Conditions
- Digital Dental Models
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- King Salman International universityUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
Background:
Digital Smile Design (DSD) has become an important component of contemporary esthetic dentistry, allowing clinicians to visualize proposed treatment outcomes and improve communication with patients and dental technicians. Conventional computer-aided design (CAD) workflows, such as Exocad, provide individualized designs but require considerable operator expertise and time and may be influenced by operator-related variability. Artificial intelligence (AI)-assisted CAD systems have recently been introduced to automate parts of the design process and potentially improve efficiency, consistency, and esthetic predictability. However, direct clinical comparisons between AI-assisted and conventional CAD workflows for laminate veneer smile design remain limited.
Aim:
This prospective randomized crossover study aims to compare AI-assisted and conventional manual CAD workflows for digital smile design in patients indicated for maxillary anterior laminate veneers, focusing on patient-reported satisfaction, esthetic and functional design outcomes, and software efficiency.
Methods:
A total of 44 adult participants indicated for laminate veneer treatment were recruited from the Oral and Dental Diagnostic Center, Faculty of Dentistry, King Salman International University. The sample size includes allowance for an anticipated 20% attrition. Participants will be randomly allocated in a 1:1 ratio to one of two crossover sequences: AI-assisted CAD followed by conventional CAD, or conventional CAD followed by AI-assisted CAD. A washout period of at least 48 hours will separate the two mock-up evaluations.
Standardized DSD photographs and intraoral scans will be obtained for each participant. Two digital smile designs will then be produced: one using AI-assisted software and the other using the conventional manual Exocad Smile Creator workflow. Both designs for each case will be completed under standardized conditions to minimize operator-related variability. The resulting virtual designs will be 3D printed to fabricate silicone indices for intraoral mock-up trials. Participants will evaluate both mock-ups while remaining blinded to the design method.
Outcomes:
The primary outcome will be patient esthetic satisfaction with each mock-up, assessed using a Visual Analog Scale (VAS; 0-10). Secondary outcomes will include objective design-based esthetic parameters, including facial landmark and plane accuracy, tooth proportions, symmetry, gingival zenith symmetry, incisal edge position, midline alignment, and contour accuracy. Functional outcomes will include occlusal contacts, incisal guidance, and interproximal contact length. Software efficiency will also be assessed through design time and operator-rated ease of use. Three blinded prosthodontists will evaluate the esthetic and functional characteristics of the virtual designs.
Statistical Analysis and Ethics:
Data normality will be evaluated using the Shapiro-Wilk test, followed by appropriate parametric or non-parametric statistical analyses. The protocol reviewed by the Research Ethics Committee of the Faculty of Dentistry, King Salman International University. Written informed consent obtained from all participants, and collected data will be coded, securely stored, and treated confidentially.
Expected Significance:
The study is designed to provide evidence on whether AI-assisted CAD workflows differ from conventional CAD workflows in patient satisfaction, esthetic and functional design outcomes, and workflow efficiency. By integrating patient-centered intraoral mock-up evaluation with objective virtual-model assessment in a crossover design, the study may help inform the evidence-based incorporation of AI into digital workflows for laminate veneer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital smile design for laminate veneers using AI-assisted CAD software | Experimental | Procedure: mockup for laminate veneers using AI-assisted CAD software |
| Digital smile design for laminate veneers using conventional CAD software | Experimental | Procedure: mockup using conventional CAD software |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The patients aged ≥18 years old.
- Patients with teeth problems indicated for laminate veneers (e.g. discoloration, defect does not involve more than 60% enamel loss, mild malposition, spacing,
- ….).
- Patients with vital teeth with no periodontal diseases.
- Patients with good oral hygiene.
Key exclusion criteria (6 listed)
- Patients with severe malocclusion
- Patients with history of bruxism or parafunctional habits
- Patients with previous prosthodontic treatment in the anterior maxilla
- Patients who are Allergic to mock-up materials
- Pregnant women.
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 |
|---|---|---|
| mockup for laminate veneers using AI-assisted CAD softwareIt specifically evaluates whether AI-assisted design can provide comparable or different outcomes in terms of patient esthetic satisfaction, objective esthetic and functional design parameters, and workflow efficiency. | Procedure or surgery | Digital smile design for laminate veneers using AI-assisted CAD software |
| mockup using conventional CAD softwareIt specifically evaluates whether conventional exocad design can provide comparable or different outcomes in terms of patient esthetic satisfaction, objective esthetic and functional design parameters, and workflow efficiency. | Procedure or surgery | Digital smile design for laminate veneers using conventional CAD software |
Primary outcome
Esthetic satisfaction for each mock up
Time frame: 5 minutes
Two virtual smile designs, one from each tested software will be 3D printed to create corresponding silicone indices for intraoral mock-up trials. Each participant will test both mock-ups in a randomized sequence, with a brief washout period between trials. After evaluating each mock-up, participants will complete a validated satisfaction questionnaire (using VAS) from 0 to 10 scores where 0 is the minimum score which represents totally dissatisfied while 10 is the maximum score which represents totally satisfied assessing: Esthetic appeal Perceived naturalness of the smile Overall smile preference
3 secondary outcomes
Esthetic Outcomes(Design-based Evaluation)
Time frame: 1 hour
Functional outcomes (Design-based Evaluation)
Time frame: 1 hour
Software efficiency
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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 mockup for laminate veneers using AI-assisted CAD software and mockup using conventional CAD software in people with Digital Dental Models, run by King Salman International university at 1 site in Egypt.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Esthetic satisfaction for each mock up (time frame: 5 minutes). 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 7 Oct 2026.