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.
Subject willing to participate in the clinical investigation, able to understand the intent risks and benefits of the clinical investigation as well as associated time commitment and follow-ups visits.
Subject has signed and dated the informed consent form (ICF) .
Subject aged 18 years or above at time of informed consent.
Subject has permanent dentition (i.e., all 2nd molars).
Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
Subject that presents a dental malocclusion classified as level 3 case complexity, as defined in the SureSmile Case Selection Guide.
Subjects who have completed aligner therapy within the last 12 months or who are in active orthodontic treatment.
Subjects with active periodontal disease or other unresolved dental conditions such as active cavities, active periodontal disease.
Parallel
SureSmile® Clear Aligners
DeviceSureSmile® 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.
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.
Perceived comfort/pain
Perceived comfort/pain experienced by subjects will be assessed using a Visual Analogue Scale (VAS) with a Wong Baker face.
SureSmile Clear Aligner Refinement rates.
SureSmile Clear Aligner Refinement rates aim to measure the number of refinements required among three different trimline groups.
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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