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

Part of paid clinical trials in Fresno, California.

Sponsor
Dentsply Sirona Implants and Consumables
Study ID
NCT07290790
Status
Recruiting
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Conditions

  • Malocclusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 29, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

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

Locations (4)

FacilityCityStateZIPSite coordinators
Costanzo OrthodonticsFresnoCalifornia93720
Chichetti
[email protected]
336-970-1350
Center for Orthodontic ExcellencePrinceton JunctionNew Jersey08550
Shah
[email protected]
609-799-4628
J Chichetti PLLC 2HuntersvilleNorth Carolina28078
Chichetti
[email protected]
336-970-1350
Brush 365 DentalFriscoTexas75035
Mahmood
[email protected]
214-534-1915

Find similar trials in Fresno, CA

By research site
Costanzo Orthodontics· Fresno, CACenter for Orthodontic Excellence· Princeton Junction, NJJ Chichetti PLLC 2· Huntersville, NCBrush 365 Dental· Frisco, TX

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