Esthetics, DentalNCT06666907
Artificial Intelligence in Smile Designing
A study testing Smilefy and EXOCAD in people with Esthetics, Dental, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to assess the accuracy and patient satisfaction of smile designs based on artificial intelligence versus conventional DSD. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Esthetics, Dental
- What is being tested?
- Smilefy and EXOCAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 May 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with esthetic problems that require digital smile design.
- Patient's age ranging from 19-30
- Good oral hygiene.
- Patients who have stable occlusion.
Who cannot join
- Poor oral hygiene.
- Patients with high caries or high plaque index.
- Patients with periodontal problems.
- Heavy bruxism habit or presence of any parafunctional habits.
- Pregnant or lactating women.
- Participating in another trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Artificial Intelligence Compared to Conventional Methods in Digital Smile Designing
The study aims to assess the accuracy and patient satisfaction of smile designs based on artificial intelligence versus conventional DSD.
Read the detailed description
Advances in digital technology are transforming dental esthetic treatments, particularly through the use of Digital Smile Design (DSD) software. These programs enable dentists to create personalized, natural-looking smile designs, improving both treatment planning and patient satisfaction. Initially, tools like PowerPoint and Photoshop were used for smile design, but modern DSD programs allow dentists to work with high-resolution 3D models to design smiles that align with facial features.
Digital smile design (DSD) technology allows dentists to create and preview new smile designs before treatment, aiding in detailed planning and clear communication with patients. This process consists of three main steps: (1) capturing digital images or videos to assess the patient's current smile, (2) analyzing these images to identify aesthetic needs, and (3) using digital tools to simulate the planned changes. Although these digital tools have greatly improved patient experience, they can be challenging to adopt in routine practice due to the required time, skill, and cost. However, this procedure could be time consuming and subjective to the dentist's skills and expertise.
To address this, artificial intelligence (AI) has been integrated into smile design software, automating tasks like facial analysis, image alignment, and smile design simulation. Accessible through apps or cloud-based platforms, AI software supports a variety of tasks, including identifying anatomical landmarks, adjusting images, and conducting live treatment simulations. DSD's integration with artificial intelligence (AI) offers further advancements, promising rapid, automated esthetic evaluations and smile designs Although AI-powered smile design tools are becoming popular in dental practices, some concerns exist that these tools may be used more for marketing purposes than for identifying genuine patient needs.
- Conditions
- Esthetics, Dental
- Being tested
- Smilefy, EXOCAD
- Keywords
- Artificial intelligence, Accuracy, Smile Design, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmilefyDevice
AI based DSD
EXOCADDevice
Conventional DSD software
| Study group | Role | What they receive |
|---|---|---|
| AI smile design | Experimental | Artificial intelligence digital smile designing software Receives: Device: Smilefy |
| Conventional smile design | Active comparator | Digital smile design software Receives: Device: EXOCAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Mean difference between the two designs measured in millimeters (mm) using geomagic control software.
Measured: immediately after the procedure
Secondary outcomes (1)
Patient satisfaction
Visual analogue scale (VAS) from 0 to 10 (0 is the least satisfaction, 10 is the maximum satisfaction)
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Dec 2024
- Primary completion1 Mar 2025
- Study completion1 May 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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Osama Shaalan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666907
- Sponsor's protocol ID
- AI
- Status last verified
- Jun 2025
- First submitted
- 27 Oct 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Artificial Intelligence Compared to Conventional Methods in Digital Smile Designing
- ClinicalTrials.gov ID
- NCT06666907
- Acronym / sponsor ID
- AI
- Conditions
- Esthetics, Dental
- Keywords
- Artificial intelligence, Accuracy, Smile Design, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 31 Oct 2024 (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.
The study aims to assess the accuracy and patient satisfaction of smile designs based on artificial intelligence versus conventional DSD.
Detailed description
Advances in digital technology are transforming dental esthetic treatments, particularly through the use of Digital Smile Design (DSD) software. These programs enable dentists to create personalized, natural-looking smile designs, improving both treatment planning and patient satisfaction. Initially, tools like PowerPoint and Photoshop were used for smile design, but modern DSD programs allow dentists to work with high-resolution 3D models to design smiles that align with facial features.
Digital smile design (DSD) technology allows dentists to create and preview new smile designs before treatment, aiding in detailed planning and clear communication with patients. This process consists of three main steps: (1) capturing digital images or videos to assess the patient's current smile, (2) analyzing these images to identify aesthetic needs, and (3) using digital tools to simulate the planned changes. Although these digital tools have greatly improved patient experience, they can be challenging to adopt in routine practice due to the required time, skill, and cost. However, this procedure could be time consuming and subjective to the dentist's skills and expertise.
To address this, artificial intelligence (AI) has been integrated into smile design software, automating tasks like facial analysis, image alignment, and smile design simulation. Accessible through apps or cloud-based platforms, AI software supports a variety of tasks, including identifying anatomical landmarks, adjusting images, and conducting live treatment simulations. DSD's integration with artificial intelligence (AI) offers further advancements, promising rapid, automated esthetic evaluations and smile designs Although AI-powered smile design tools are becoming popular in dental practices, some concerns exist that these tools may be used more for marketing purposes than for identifying genuine patient needs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI smile design | Experimental | Device: SmilefyArtificial intelligence digital smile designing software |
| Conventional smile design | Active comparator | Device: EXOCADDigital smile design software |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with esthetic problems that require digital smile design.
- Patient's age ranging from 19-30
- Good oral hygiene.
- Patients who have stable occlusion.
Key exclusion criteria (6 listed)
- Poor oral hygiene.
- Patients with high caries or high plaque index.
- Patients with periodontal problems.
- Heavy bruxism habit or presence of any parafunctional habits.
- Pregnant or lactating 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 |
|---|---|---|
| SmilefyAI based DSD | Device | AI smile design |
| EXOCADConventional DSD software | Device | Conventional smile design |
Primary outcome
Accuracy
Time frame: immediately after the procedure
Mean difference between the two designs measured in millimeters (mm) using geomagic control software.
1 secondary outcome
Patient satisfaction
Time frame: immediately after the procedure
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 11 Jun 2025.
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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 Smilefy and EXOCAD in people with Esthetics, Dental, run by Cairo 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 4 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: finished, as of the sponsor's last update on 11 Jun 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 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?
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?
Accuracy (time frame: immediately after the procedure). 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 11 Jun 2025.