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

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Other: Invisalign® SmileView™; Other: Invisalign aligners

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Dubai, United Arab Emirates
    • Private orthodontic offices of Invisalign Diamond Plus Elite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• chronic diseases
• previous orthodontic treatment
• poor oral hygiene
• periodontal diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Invisalign® SmileView™	Other: Invisalign® SmileView™; Pretreatment smiles were captured using the Invisalign® SmileView™ to simulate their new smiles before treatment was started.
Active Comparator: Invisalign aligners	Other: Invisalign aligners; Patients were then treated using upper and lower Invisalign aligners with average treatment time of 12±3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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.	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	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.	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.	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).	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	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	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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Investigators: Principal Investigator: Samar M Adel, PhD, Alexandria University; Study Chair: Yashodhan M Bichu, DSATP, Faculty of Dentistry, University of British Columbia, Vancouver, Canada; Study Chair: Srirengalakshmi Muthuswamy Pandian, PhD, Saveetha Dental College, Saveetha Insitute of Medical and Technical Sciences, Chennai, India.; Study Chair: Waddah Sabouni, Private Practice, Invisalign Centre Dubai United Arab Emirates.; Study Chair: Chandani Shah, Private practice, Mumbai, India; Study Chair: Nikhillesh Vaid, PhD, Saveetha Dental College, Saveetha Insitute of Medical and Technical Sciences, Chennai, India.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 5, 2020

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Estimated): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: SRB/SDC/ORTHO-2119/23/019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No