MalocclusionNCT06123585

Artificial Intelligence (AI) Empowered Smile Simulations: Do They Accurately Predict Actual Post Treatment Outcomes

A study testing Invisalign® SmileView™ and Invisalign aligners in people with Malocclusion, run by Nourhan M.Aly at 1 site in United Arab Emirates.

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

The aim of the present study is to assess the predictability of Invisalign® SmileView™ for digital AI smile simulation in comparison to actual smile treatment outcomes, using various smile assessment parameters. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Malocclusion
What is being tested?: Invisalign® SmileView™ and Invisalign aligners
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited Arab Emirates
Study dates: 1 Jan 2018to 5 Jul 2020
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

healthy systemic condition with no chronic diseases
no previous orthodontic treatment
adequate oral hygiene
a healthy periodontium.

Who cannot join

chronic diseases
previous orthodontic treatment
poor oral hygiene
periodontal diseases

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

Private orthodontic offices of Invisalign Diamond Plus Elite
Dubai

Other trials in United Arab Emirates

About this study

Conditions: Malocclusion
Being tested: Invisalign® SmileView™, Invisalign aligners
Medical subject headings: Malocclusion

What participants receive

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

Invisalign® SmileView™Other
Pretreatment smiles were captured using the Invisalign® SmileView™ to simulate their new smiles before treatment was started.
Invisalign alignersOther
Patients were then treated using upper and lower Invisalign aligners with average treatment time of 12±3 months.

Study groups in NCT06123585
Study group	Role	What they receive
Invisalign® SmileView™	Experimental	Not described Receives: Other: Invisalign® SmileView™
Invisalign aligners	Active comparator	Not described Receives: Other: Invisalign aligners

What is being measured

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

Smile line
The extent of the vertical tooth display on smiling or the elevation of the upper lip in relation to the maxillary incisors. Three types of smile lines have been described- high, average, and low. A high smile shows the maxillary anterior teeth along with a significant amount of gingiva, an average smile shows maxillary anterior teeth with only interproximal gingiva, and a low smile typically shows less than two-thirds of the maxillary anterior teeth
Measured: through study completion, an average of 1 year
Smile arc
The relationship between the curvature of the maxillary anterior teeth and upper border of the lower lip. It is defined by drawing a line along the maxillary central incisal edges to the cusp tips of maxillary canines, which is related to another line drawn across the superior border of the lower lip. In subjects whose maxillary teeth are covered by lower lip, smile arc is designated as "not available". Three types of smile arcs have been described- "parallel to the teeth" (when the two lines follow the same curvature) also called a consonant smile, and a non-consonant smile, if the two lines are not parallel. A non-consonant smile can either be "straight" (with flatter curvature of the maxillary anterior teeth in relation to the lower lip) or "reverse" (when the maxillary anterior teeth form a reverse curve in relation to lower lip).
Measured: through study completion, an average of 1 year
The most posterior teeth displayed
Smiles are categorized as displaying teeth up to the canines, first premolars, second premolars, or the first molars. A tooth is counted when more than half of its surface is visible.
Measured: through study completion, an average of 1 year
The philtrum height
Distance measured in millimeters from subspinale (the base of the nose at the midline) to the most inferior portion of the upper lip on the vermilion tip beneath the philtral columns
Measured: through study completion, an average of 1 year
Commissure height
Distance measured in millimeters from a line constructed from the alar bases through subspinale and then from the commissures perpendicular to this line. The differential lip growth exhibits the difference in height in philtrum and commissural height in adolescents.
Measured: through study completion, an average of 1 year
Smile width/Inter-commissure width
The distance (mm) from outer commissure to outer commissure on smile in millimeters.
Measured: through study completion, an average of 1 year
Smile index
The ratio between the horizontal smile width and the vertical smile height during smiling (smile width/smile height).
Measured: through study completion, an average of 1 year
Maxillary inter-canine width
distance from the distal aspect of the right canine to the distal aspect of the left canine in millimeters
Measured: through study completion, an average of 1 year
Buccal corridor
It is the space created between the buccal surface of the posterior teeth and the lip corners when the patient smiles. Orthodontists often refer to buccal corridors as "negative spaces". The buccal corridor is measured from the mesial line angle of the maxillary first premolars to the interior portion of the commissure of the lips. Moore et al [16]. have previously quantified a buccal corridor of 28% as medium-narrow, 15% as medium, 10% as medium-broad, and 2% as broad smile fullness
Measured: through study completion, an average of 1 year
Amount of lower incisor show
The amount of lower incisor display which can be categorized into either 1) No show of lower incisors during smiling, 2) partial lower incisor exposure or 3) full length lower incisor exposure.
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 Jan 20185 Jul 2020

First posted9 Nov 2023
Study start1 Jan 2018
Primary completion1 Jul 2020
Study completion5 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MalocclusionStudies 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: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06123585
Sponsor's protocol ID: SRB/SDC/ORTHO-2119/23/019
Status last verified: Nov 2023
First submitted: 1 Nov 2023
Last updated: 9 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Adel SM, Bichu YM, Pandian SM, Sabouni W, Shah C, Vaiid N. Clinical audit of an artificial intelligence (AI) empowered smile simulation system: a prospective clinical trial. Sci Rep. 2024 Aug 21;14(1):19385. doi: 10.1038/s41598-024-69314-6.
PubMed 39169095

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
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Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
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Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
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Evaluation of Corticotomy-Assisted Canine Retraction Rate
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Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery
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All Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Artificial Intelligence (AI) Empowered Smile Simulations: Do They Accurately Predict Actual Post Treatment Outcomes
ClinicalTrials.gov ID: NCT06123585
Acronym / sponsor ID: SRB/SDC/ORTHO-2119/23/019
Conditions: Malocclusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Nourhan M.AlyUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 1 Jul 2020 (actual)
Study completion: 5 Jul 2020 (actual)
First posted: 9 Nov 2023 (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.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Invisalign® SmileView™	Experimental	Other: Invisalign® SmileView™
Invisalign aligners	Active comparator	Other: Invisalign aligners

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

healthy systemic condition with no chronic diseases
no previous orthodontic treatment
adequate oral hygiene
a healthy periodontium.

Key exclusion criteria (4 listed)

chronic diseases
previous orthodontic treatment
poor oral hygiene
periodontal diseases

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
Invisalign® SmileView™Pretreatment smiles were captured using the Invisalign® SmileView™ to simulate their new smiles before treatment was started.	Other	Invisalign® SmileView™
Invisalign alignersPatients were then treated using upper and lower Invisalign aligners with average treatment time of 12±3 months.	Other	Invisalign aligners

Primary outcome

Smile line
Time frame: through study completion, an average of 1 year
The extent of the vertical tooth display on smiling or the elevation of the upper lip in relation to the maxillary incisors. Three types of smile lines have been described- high, average, and low. A high smile shows the maxillary anterior teeth along with a significant amount of gingiva, an average smile shows maxillary anterior teeth with only interproximal gingiva, and a low smile typically shows less than two-thirds of the maxillary anterior teeth
Smile arc
Time frame: through study completion, an average of 1 year
The relationship between the curvature of the maxillary anterior teeth and upper border of the lower lip. It is defined by drawing a line along the maxillary central incisal edges to the cusp tips of maxillary canines, which is related to another line drawn across the superior border of the lower lip. In subjects whose maxillary teeth are covered by lower lip, smile arc is designated as "not available". Three types of smile arcs have been described- "parallel to the teeth" (when the two lines follow the same curvature) also called a consonant smile, and a non-consonant smile, if the two lines are not parallel. A non-consonant smile can either be "straight" (with flatter curvature of the maxillary anterior teeth in relation to the lower lip) or "reverse" (when the maxillary anterior teeth form a reverse curve in relation to lower lip).
The most posterior teeth displayed
Time frame: through study completion, an average of 1 year
Smiles are categorized as displaying teeth up to the canines, first premolars, second premolars, or the first molars. A tooth is counted when more than half of its surface is visible.
The philtrum height
Time frame: through study completion, an average of 1 year
Distance measured in millimeters from subspinale (the base of the nose at the midline) to the most inferior portion of the upper lip on the vermilion tip beneath the philtral columns
Commissure height
Time frame: through study completion, an average of 1 year
Distance measured in millimeters from a line constructed from the alar bases through subspinale and then from the commissures perpendicular to this line. The differential lip growth exhibits the difference in height in philtrum and commissural height in adolescents.
Smile width/Inter-commissure width
Time frame: through study completion, an average of 1 year
The distance (mm) from outer commissure to outer commissure on smile in millimeters.
Smile index
Time frame: through study completion, an average of 1 year
The ratio between the horizontal smile width and the vertical smile height during smiling (smile width/smile height).
Maxillary inter-canine width
Time frame: through study completion, an average of 1 year
distance from the distal aspect of the right canine to the distal aspect of the left canine in millimeters
Buccal corridor
Time frame: through study completion, an average of 1 year
It is the space created between the buccal surface of the posterior teeth and the lip corners when the patient smiles. Orthodontists often refer to buccal corridors as "negative spaces". The buccal corridor is measured from the mesial line angle of the maxillary first premolars to the interior portion of the commissure of the lips. Moore et al [16]. have previously quantified a buccal corridor of 28% as medium-narrow, 15% as medium, 10% as medium-broad, and 2% as broad smile fullness
Amount of lower incisor show
Time frame: through study completion, an average of 1 year
The amount of lower incisor display which can be categorized into either 1) No show of lower incisors during smiling, 2) partial lower incisor exposure or 3) full length lower incisor exposure.

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 9 Nov 2023.
Derived from this study: PubMed 39169095Adel SM, Bichu YM, Pandian SM, Sabouni W, Shah C, Vaiid N. Clinical audit of an artificial intelligence (AI) empowered smile simulation system: a prospective clinical trial. Sci Rep. 2024 Aug 21;14(1):19385. doi: 10.1038/s41598-024-69314-6.

Related trials for Malocclusion

Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Enrolling by invitation
Evaluation of Corticotomy-Assisted Canine Retraction Rate
Malocclusion, Corticotomy
Not yet recruiting
Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery
Malocclusion

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.

Samar M Adel, PhD principal investigator

Alexandria University

Yashodhan M Bichu, DSATP study chair

Faculty of Dentistry, University of British Columbia, Vancouver, Canada

Srirengalakshmi Muthuswamy Pandian, PhD study chair

Saveetha Dental College, Saveetha Insitute of Medical and Technical Sciences, Chennai, India.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Invisalign® SmileView™ and Invisalign aligners in people with Malocclusion, run by Nourhan M.Aly at 1 site in United Arab Emirates.

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 4 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 9 Nov 2023. 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 United Arab Emirates. 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?

Smile line (time frame: through study completion, an average of 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06123585, which also lists 1 linked publication.

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 9 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.