About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SureSmile® Clear Aligners