This is a three-armed, multicenter clinical study evaluating the SureSmile clear aligner medical device. The primary objective is to confirm the safety and assess the accuracy of different tooth movements. In addition, the study will investigate and compare three different trimline designs: Scalloped, Straight, and Straight Extended.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
SureSmile® Clear Aligners are Custom-made (EU)/patient matched (US) medical devices made to fit appliance with different diameters and lengths to accommodate subjects with different mouth shapes and sizes. This clinical investigation consists of three different trimline designs groups: * SureSmile aligner Scallop trimline design * SureSmile aligner Straight trimline design * SureSmile aligner Straight extended trimline design All pre-treatment, treatment, and post-treatment protocols and materials used in all groups are identical, except for the type of trimline design.
Costanzo Orthodontics
Fresno, California, United States
Center for Orthodontic Excellence
Princeton Junction, New Jersey, United States
Brush 365 Dental
Frisco, Texas, United States
Clinica dental Francesc Batlle
Barcelona, Spain
Tooth movement accuracy at subject level across different movement types
The primary objective of this clinical investigation is to provide a detailed assessment of tooth movement accuracy at subject level across different movement types. For each patient, all teeth will be evaluated in five dimensions of movement: 1. Mesiodistal translation \[mm\] 2. Buccolingual translation \[mm\] 3. Intrusive/extrusive movement \[mm\] 4. Mesiodistal angulation \[degrees\] 5. Buccolingual torque \[degrees\] Accuracy will be determined by comparing the predicted versus achieved tooth positions for 16 teeth in each subject using the formula: "Percentage of accuracy" =100 - \[(\|predicted-achieved\| / \|predicted\|) \*100\]" Subject effectiveness is the overall mean of all the collected "Percentage of accuracy" values.
Time frame: At start of aligner treatment and at end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).
Perceived comfort/pain
Perceived comfort/pain experienced by subjects will be assessed using a Visual Analogue Scale (VAS) with a Wong Baker face.
Time frame: Every 8 weeks from start of aligner treatment up to to end of aligner treatment according to predetermined treatment plan (on average 6-18 months). Plus every 8 weeks during refinement period, on average 8-12 weeks.
SureSmile Clear Aligner Refinement rates.
SureSmile Clear Aligner Refinement rates aim to measure the number of refinements required among three different trimline groups.
Time frame: At end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.
Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.
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The Sanford
Bexleyheath, United Kingdom
Time frame: From Day 0 up to Retainer Delivery Visit, on average 18 months post Day 0.