An interventional study of Invisalign® SmileView™ and Invisalign aligners in Malocclusion, sponsored by Nourhan M.Aly. Completed at 1 site in United Arab Emirates. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by Nourhan M.Aly · Not applicable, Interventional, and Other
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.
469 studies on the registry are indexed under Malocclusion; 91 are open to participants now.
This study's enrollment of 24 is below the median of 36 across 383 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Nourhan M.Aly is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Other: Invisalign® SmileView™
Other: Invisalign aligners
Pretreatment smiles were captured using the Invisalign® SmileView™ to simulate their new smiles before treatment was started.
Patients were then treated using upper and lower Invisalign aligners with average treatment time of 12±3 months.
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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: through study completion, an average of 1 year
Ran from Jan 2018 to primary completion in Jul 2020, 30 months.
Of 260 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's 30 months is above that.
Counting every sponsor, half of 272 studies reached it within 15 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Nourhan M.Aly