Actively Recruiting
A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.
Led by Dentsply Sirona Implants and Consumables · Updated on 2026-03-09
90
Participants Needed
6
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Willing to participate and understand study risks, benefits, and time commitments
- Signed informed consent form
- Aged 18 years or older at consent
- Have permanent dentition including all second molars
- Dental malocclusion with Level 1 or 2 case complexity, including:
- Crowding or spacing 646 mm in one or both arches
- Midline deviation 643 mm
- Overjet 644 mm
- Overbite 643 mm
- Anterior open bite 641 mm
- Treatment plan may include intermaxillary elastics within defined limits
You will not qualify if you...
- Unlikely to comply with study procedures or follow-up visits
- Dental malocclusion classified as Level 3 case complexity
- Completed aligner therapy in last 12 months or currently in active orthodontic treatment
- Active periodontal disease or unresolved dental conditions such as cavities
- Treatment plans requiring transverse expansion >4 mm per arch or >2 mm per quadrant, or skeletal transverse correction
- Sagittal correction exceeding half-cusp discrepancy in molar or canine relationships
- Vertical correction beyond Level 1 and 2 thresholds (overbite >3 mm, open bite >1 mm), or vertical elastics >3 mm
- Temporo-Mandibular Joint disorders or history of headaches or migraines
- Known plastic allergies
- Skeletal discrepancies requiring orthognathic surgery, rapid palatal expansion, orthopedic interventions, cross-bites, or mandibular deviations
- Use of Temporary Anchor Devices, plates, fixed anchorage devices, functional appliances, orthopedic or skeletal sagittal correction, or hybrid fixed appliances
- Uncontrolled para-functional habits such as bruxism
- Unstable psychiatric illness
- Recent myocardial infarction, cerebrovascular accident, or cardiac-valvular prosthesis placement (within 3 months)
- Hemorrhagic diathesis
- Severe liver dysfunction
- Known or suspected current malignancy
- Known pregnancy at enrollment
- Previous enrollment in this clinical investigation
- Involvement in the planning or conduct of this study
- Participation in another clinical study that may interfere with this investigation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
U
Ulrika Bonander
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here