Actively Recruiting
A Prospective, Multicenter, Randomized Clinical Investigation to Assess Tooth Movement Accuracy Using SureSmile Clear Aligners With Three Different Trimline Designs
Led by Dentsply Sirona Implants and Consumables · Updated on 2026-03-09
90
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the SureSmile clear aligner medical device in a multicenter clinical study. The study's main goal is to confirm the safety and assess the accuracy of different tooth movements when using these aligners. Additionally, the study compares three different trimline designs: Scalloped, Straight, and Straight Extended, to see how they perform during treatment for dental malocclusion. Participants will receive SureSmile clear aligners customized to fit their mouths, with each group using a different trimline design. The three groups include scalloped trimline, straight trimline, and straight extended trimline (2 mm). All other treatment protocols and materials remain the same across groups. Treatment typically lasts between 6 and 18 months, depending on the predetermined plan. During the study, participants' tooth movement accuracy will be measured at the start and end of aligner treatment. Comfort and pain levels will be recorded every 8 weeks throughout treatment and during a refinement period lasting about 8 to 12 weeks. The study also monitors any adverse events or device issues from the start until around 18 months later, when retainers are delivered. This careful follow-up helps assess safety and treatment outcomes.
CONDITIONS
Brief Title
A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to participate and understand the study risks, benefits, and time commitments
- Signed informed consent form
- Aged 18 years or older at consent
- Permanent dentition including all second molars
- Dental malocclusion consistent with Levels 1 and 2 case complexity as defined by SureSmile Case Selection Guide
- Crowding or spacing of 6 mm or less in one or both arches
- Midline deviation of 3 mm or less
- Overjet of 4 mm or less
- Overbite of 3 mm or less
- Anterior open bite of 1 mm or less
- Intermaxillary elastics allowed within treatment plan under defined limits
You will not qualify if you...
- Unlikely to comply with procedures or follow-up visits
- Dental malocclusion classified as Level 3 case complexity
- Completed aligner therapy within last 12 months or currently in orthodontic treatment
- Active periodontal disease or unresolved dental conditions such as cavities
- Treatment plans requiring transverse expansion greater than 4 mm per arch or 2 mm per quadrant
- Need for skeletal transverse correction
- Sagittal correction exceeding half-cusp discrepancy in molar or canine relationships
- Vertical correction beyond Level 1 and 2 thresholds or vertical elastics exceeding 3 mm
- TMJ disorders or history of headaches or migraines
- Known plastic allergies
- Skeletal discrepancies requiring surgery or orthopedic intervention
- Use of TADs, plates, fixed anchorage, functional appliances, hybrid fixed appliances
- Uncontrolled para-functional habits like bruxism
- Unstable psychiatric illness
- Recent myocardial infarction, cerebrovascular accident, or cardiac-valvular prosthesis placement within 3 months
- Hemorrhagic diathesis
- Severe liver dysfunction
- Current or suspected malignancy
- Known pregnancy at enrollment
- Previous enrollment in this study
- Involvement in study planning or conduct
- Participation in other clinical trials that may interfere with this one
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 18 months
Participants receive SureSmile® Clear Aligners with one of three different trimline designs as part of their orthodontic treatment.
Visits every 8 weeks for aligner adjustments and assessments
Duration - Up to 18 months from treatment start
Participants are monitored for adverse events, device effects, and device deficiencies up to the retainer delivery visit.
Visits as needed up to retainer delivery
Trial Site Locations
Total: 6 locations
1
Costanzo Orthodontics
Fresno, California, United States, 93720
Actively Recruiting
2
Center for Orthodontic Excellence
Princeton Junction, New Jersey, United States, 08550
Not Yet Recruiting
3
J Chichetti PLLC 2
Huntersville, North Carolina, United States, 28078
Actively Recruiting
4
Brush 365 Dental
Frisco, Texas, United States, 75035
Actively Recruiting
5
Clinica Dental Ortiz Puigpelat
Barcelona, Spain, 08028
Not Yet Recruiting
6
The Sanford
Bexleyheath, United Kingdom, DA6 8AA
Not Yet Recruiting
Research Team
F
Freja Freedman
U
Ulrika Bonander
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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