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

NCT ID: NCT07290790

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2028-02-01

Brief Summary

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.

Conditions

Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Extended trimline design

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

Group Type: EXPERIMENTAL

SureSmile® Clear Aligners

Intervention Type: DEVICE

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.

Scalloped trimline design

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

Group Type: EXPERIMENTAL

SureSmile® Clear Aligners

Intervention Type: DEVICE

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.

Straight trimline design

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

Group Type: EXPERIMENTAL

SureSmile® Clear Aligners

Intervention Type: DEVICE

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.

Interventions

SureSmile® Clear Aligners

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

The Sanford

Bexleyheath, , United Kingdom

Countries

United States; Spain; United Kingdom

Central Contacts

Freja Freedman

Role: CONTACT

Phone: +46 702107415

Email: freja.freedman@dentsplysirona.com

Ulrika Bonander

Role: CONTACT

Phone: +46 706440844

Email: ulrika.bonander@dentsplysirona.com

Facility Contacts

Chichetti

Role: primary

Shah

Role: primary

Mahmood

Role: primary

Salman

Role: primary

Shaffie

Role: primary

Other Identifiers

C-OR-25-002

Identifier Type: -

Identifier Source: org_study_id