Recruiting

SureSmile

Sponsor:

Dentsply Sirona Implants and Consumables

Code:

NCT07290790

Conditions

Malocclusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SureSmile® Clear Aligners

Study Details

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 ID

NCT07290790

Start date

Jan 29, 2026

Status verified date

Aug, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Scalloped trimline design

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

experimental: Straight trimline design

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

experimental: Extended trimline design

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

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.

Primary outcome measure

  • Tooth movement accuracy at subject level across different movement types [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Freja Freedman

+46 702107415freja.freedman@dentsplysirona.com

Ulrika Bonander

+46 706440844ulrika.bonander@dentsplysirona.com

Locations

Costanzo Orthodontics

Recruiting

Fresno, California, United States, 93720

Contacts

Chichetti

+1 3369701350drc@cpdentalwellness.com

J Chichetti PLLC 2

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Chichetti

+1 3369701350drc@cpdentalwellness.com

Brush 365 Dental

Recruiting

Frisco, Texas, United States, 75035

Contacts

Mahmood

+1 2145341915drmahmood@brush365dental.com

More Information

Sponsor

Dentsply Sirona Implants and Consumables

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Dentsply Sirona Implants and Consumables on 2026-08-11.