A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.

Exclusion Criteria24

• 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.
• Subjects with treatment plans requiring transverse correction requiring expansion greater than 4 mm per arch or 2 mm per quadrant, or any skeletal transverse correction.
• Treatment plans requiring sagittal correction exceeding a half-cusp discrepancy (i.e., \>½ unit) in molar or canine relationships.
• Subjects with treatment plans require vertical correction beyond Level 1 and 2 thresholds (i.e., overbite \>3 mm or anterior/posterior open bite \>1 mm), or vertical elastics exceeding 3 mm.
• TMJ (Temporo-Mandibular Join) disorders or history of headaches or migraines.
• Participants with known history of plastic allergies.
• Subjects with presence of skeletal discrepancies necessitating orthognathic surgery, rapid palatal expansion, other orthopedic intervention, unilateral or bilateral cross-bites, mandibular deviations in association with the diagnosed malocclusion
• The use of TADs (Temporary Anchor Devices), plates, other fixed anchorage ancillaries or the use of functional appliances (distalizers, growth modification devices), any approach involving orthopedic or skeletal sagittal correction or the use of hybrid fixed appliances are not considered part of the scope of this clinical investigation and these subjects are not eligible.
• Uncontrolled para-functional habits, e.g., bruxism.
• Any other condition that would make the subject unsuitable for participation, including but not limited to:
• Unstable psychiatric illness.
• Recent myocardial infarction (\< 3 months\*).
• Recent cerebrovascular accident (\< 3 months\*).
• Recent cardiac-valvular prosthesis placement (\< 3 months\*).
• Hemorrhagic diathesis.
• Severe liver dysfunction.
• Known or suspected current malignancy.
• Known pregnancy at the time of enrolment.
• Previous enrolment in the present clinical investigation.
• Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).
• Participation in another clinical investigation that may interfere with the present clinical investigation.