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New study compares three aligner designs for perfect smiles

NCT ID NCT07290790

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This study tests SureSmile clear aligners in 90 adults with crooked teeth (malocclusion). It compares three different aligner edge designs to see which moves teeth most accurately. Participants wear the aligners as usual, and researchers measure tooth movement against predictions. The goal is to improve treatment precision and comfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SureSmile clear aligners (dental device)
What this could lead to
If successful, this study could help orthodontists choose the best aligner design for more predictable tooth movement, improving treatment outcomes.
What could go wrong
This is a post-market study with only 90 participants, so results may not apply to everyone. Different trimlines may not show clear advantages, and individual results vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brush 365 Dental

    RECRUITING

    Frisco, Texas, 75035, United States

  • Center for Orthodontic Excellence

    NOT_YET_RECRUITING

    Princeton Junction, New Jersey, 08550, United States

  • Clinica Dental Ortiz Puigpelat

    NOT_YET_RECRUITING

    Barcelona, 08028, Spain

  • Costanzo Orthodontics

    RECRUITING

    Fresno, California, 93720, United States

  • J Chichetti PLLC 2

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • The Sanford

    NOT_YET_RECRUITING

    Bexleyheath, DA6 8AA, United Kingdom

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