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

A Prospective, Multicenter, Randomized, Post-market Clinical Investigation to Assess the Accuracy of Different Tooth Movements for Patients Undergoing Clear Aligner Therapy (CAT) With SureSmile® Clear Aligners With Three Different Trimlines.

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.

Study Overview

• Status: Recruiting
• Conditions: Malocclusion
• Intervention / Treatment: Device: SureSmile® Clear Aligners

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Freja Freedman; Phone Number: +46 702107415; Email: freja.freedman@dentsplysirona.com
• Study Contact Backup: Name: Ulrika Bonander; Phone Number: +46 706440844; Email: ulrika.bonander@dentsplysirona.com

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Not yet recruiting
    • Clinica Dental Ortiz Puigpelat
    • Contact: Salman; Phone Number: +34 (0)20 8303 7051; Email: ortho.admin@thesandford.com
• United Kingdom
  • Bexleyheath, United Kingdom, DA6 8AA
    • Not yet recruiting
    • The Sanford
    • Contact: Shaffie; Phone Number: +44 7702088334; Email: shaffie1@hotmail.co.uk
• United States
  • California
    • Fresno, California, United States, 93720
      • Recruiting
      • Costanzo Orthodontics
      • Contact: Chichetti; Phone Number: 336-970-1350; Email: drc@cpdentalwellness.com
  • New Jersey
    • Princeton Junction, New Jersey, United States, 08550
      • Not yet recruiting
      • Center for Orthodontic Excellence
      • Contact: Shah; Phone Number: 609-799-4628; Email: Drshah@coesmiles.com
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • J Chichetti PLLC 2
      • Contact: Chichetti; Phone Number: 336-970-1350; Email: drc@cpdentalwellness.com
  • Texas
    • Frisco, Texas, United States, 75035
      • Recruiting
      • Brush 365 Dental
      • Contact: Mahmood; Phone Number: 214-534-1915; Email: drmahmood@brush365dental.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scalloped trimline design; SureSmile® Clear Aligner (Group 1) with scalloped trimline design	Device: 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.
Experimental: Straight trimline design; SureSmile® Clear Aligner (Group 2) with straight trimline design	Device: 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.
Experimental: Extended trimline design; SureSmile® Clear Aligner (Group 3) with extended trimline design (2 mm)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Mesiodistal translation [mm]; Buccolingual translation [mm]; Intrusive/extrusive movement [mm]; Mesiodistal angulation [degrees]; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived comfort/pain	Perceived comfort/pain experienced by subjects will be assessed using a Visual Analogue Scale (VAS) with a Wong Baker face.	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.	SureSmile Clear Aligner Refinement rates aim to measure the number of refinements required among three different trimline groups.	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.	Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.	From Day 0 up to Retainer Delivery Visit, on average 18 months post Day 0.

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: C-OR-25-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No