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

NCT06123585 | Completed

• 1 other identifier: SRB/SDC/ORTHO-2119/23/019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Invisalign® SmileView™

EXPERIMENTAL

Other: Invisalign® SmileView™

Invisalign aligners

ACTIVE COMPARATOR

Other: Invisalign aligners

Interventions

Invisalign® SmileView™ OTHER

Pretreatment smiles were captured using the Invisalign® SmileView™ to simulate their new smiles before treatment was started.

Invisalign® SmileView™

Invisalign aligners OTHER

Patients were then treated using upper and lower Invisalign aligners with average treatment time of 12±3 months.

Invisalign aligners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nourhan M.Aly: lead

Study Sites (1)

Private orthodontic offices of Invisalign Diamond Plus Elite

Dubai, United Arab Emirates

Location

Related Publications (1)

• 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.

  PMID: 39169095 DERIVED

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Samar M Adel, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 9, 2023
• Study Start: January 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 5, 2020
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

AE (1)