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

NCT07290790 | Recruiting FDA Device

• 1 other identifier: C-OR-25-002
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At start of aligner treatment and at end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).

Secondary Outcomes (3)

• Perceived comfort/pain

  Every 8 weeks from start of aligner treatment up to to end of aligner treatment according to predetermined treatment plan (on average 6-18 months). Plus every 8 weeks during refinement period, on average 8-12 weeks.

• SureSmile Clear Aligner Refinement rates.

  At end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).

• Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.

  From Day 0 up to Retainer Delivery Visit, on average 18 months post Day 0.

Study Arms (3)

Scalloped trimline design

EXPERIMENTAL

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

Device: SureSmile® Clear Aligners

Straight trimline design

EXPERIMENTAL

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

Device: SureSmile® Clear Aligners

Extended trimline design

EXPERIMENTAL

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

Device: SureSmile® Clear Aligners

Interventions

SureSmile® Clear Aligners 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.

Extended trimline design; Scalloped trimline design; Straight trimline design

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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\*).

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (6)

Costanzo Orthodontics

Fresno, California, 93720, United States

RECRUITING

Center for Orthodontic Excellence

Princeton Junction, New Jersey, 08550, United States

NOT YET RECRUITING

J Chichetti PLLC 2

Huntersville, North Carolina, 28078, United States

RECRUITING

Brush 365 Dental

Frisco, Texas, 75035, United States

RECRUITING

Clinica Dental Ortiz Puigpelat

Barcelona, 08028, Spain

NOT YET RECRUITING

The Sanford

Bexleyheath, DA6 8AA, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Freja Freedman

CONTACT

+46 702107415; freja.freedman@dentsplysirona.com

Ulrika Bonander

CONTACT

+46 706440844; ulrika.bonander@dentsplysirona.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 18, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); ES (1); GB (1)