Comparing scalloped, straight, and straight-extended trimlines for SureSmile clear aligners

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter clinical investigation enrolls adults with permanent dentition and mild-to-moderate malocclusion (Levels 1–2) and assigns them to one of three treatment arms using SureSmile clear aligners with scalloped, straight, or straight-extended trimlines. The primary objectives are to confirm device safety and measure the accuracy of planned versus achieved tooth movements for different trimline designs. Participants will receive the assigned aligner treatment and attend scheduled follow-ups at one of three U.S. centers where clinicians will document outcomes using clinical exams and digital scans. Results will compare movement accuracy metrics and any adverse events across the three trimline groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Costanzo Orthodontics
  Fresno, California, United States Recruiting
• J Chichetti PLLC 2
  Huntersville, North Carolina, United States Recruiting
• Brush 365 Dental
  Frisco, Texas, United States Recruiting
• Center for Orthodontic Excellence
  Princeton Junction, New Jersey, United States Not yet recruiting
• Clinica Dental Ortiz Puigpelat
  Barcelona, Spain Not yet recruiting
• The Sanford
  Bexleyheath, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Freja Freedman
• Email: freja.freedman@dentsplysirona.com
• Phone: +46 702107415

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.