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

Dentsply

Status: Not yet enrolling

Conditions: Malocclusion

Treatments: Device: SureSmile® Clear Aligners

Study type: Interventional

Funder types: Industry

Identifiers

NCT07290790

C-OR-25-002

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

• Subject with a dental malocclusion, consistent with Levels 1 and 2 case complexity and within the clinical references as defined in the SureSmile Case Selection Guide.

  • Crowding or spacing must be ≤6mm present in one or both arches consistent with level 1 and 2 of case complexity.
  • Midline deviation must be ≤3 mm consistent with level 1 and 2 of case complexity.
  • Overjet must be ≤4 mm consistent with level 1 and 2 case complexity.
  • Overbite must be ≤3 mm consistent with level 1 and 2 case complexity.
  • Anterior open bite must be ≤1 mm, consistent with level 1 and 2 case complexity.

• Intermaxillary elastics may be included within the treatment plan to support sagittal, vertical, or transverse correction within the limits defined under exclusion criteria.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Scalloped trimline design

Experimental group

Description:

SureSmile® Clear Aligner (Group 1) with scalloped trimline design

Treatment:

Device: SureSmile® Clear Aligners

Straight trimline design

Experimental group

Description:

SureSmile® Clear Aligner (Group 2) with straight trimline design

Treatment:

Device: SureSmile® Clear Aligners

Extended trimline design

Experimental group

Description:

SureSmile® Clear Aligner (Group 3) with extended trimline design (2 mm)

Treatment:

Device: SureSmile® Clear Aligners