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New digital tray aims to speed up braces placement

NCT ID NCT06266130

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests whether a new digital bonding tray can place braces faster and more accurately than the standard method of attaching each bracket one by one. About 178 people aged 11 and older who need braces on both upper and lower teeth will take part. The main goal is to see if the digital tray reduces the time spent preparing and bonding the braces.

What this could mean

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

Active substance
Digital Bonding Tray (a device for placing braces)
What this could lead to
If successful, this could make getting braces quicker and require fewer adjustment visits, improving the orthodontic experience.
What could go wrong
This is a relatively small, early-stage study focused on efficiency, not health outcomes. The digital method may not prove faster or more accurate in all cases.

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

138 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Jun 2027

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

11 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Subject is 11 years of age or older. 2. Subject is able and willing to provide their own informed Assent AND Subject or Legal Authorized Representative (LAR) is able and willing to sign the Informed Consent Form 3. Subject is able and willing to be available for all scheduled study visits. 4. The Subject is treatment-planned for required comprehensive orthodontic treatment for both arches using brackets. 5. Subject's current orthodontic treatment plan does not include extractions, orthognathic surgery, post-orthodontic restorative treatment (with the exception of minor spaces for tooth shaping post-orthodontic treatment), or temporary anchorage devices. 6. Subject has all permanent teeth erupted (dentition including second molars or in the opinion of the investigator, the 2nd molars will have completed eruption and alignment during the treatment period). 7. Subject has an Angle Class I or Class II relationships. 8. The Subject has mild to moderate crowding (crowding less than 5 mm in each arch) 9. Subject has an overbite measuring between -1 mm (open bite) and 5 mm (deep bite). 10. The Subject's intra-oral scan must have been taken within 90 days of bracket placement. 11. The Subject is anticipated to complete treatment within 18 to 24 months. Exclusion Criteria: 1. Subject has a history of adverse reaction to any materials used in this study. 2. Subject is pregnant or breast feeding. 3. Subject has advanced periodontal disease. 4. Subject has non-movable teeth (e.g., implants, bridges, ankylosed teeth). 5. Subject has more than 1 tooth excluded from the initial bonding (not including 2nd molars), e.g., no bracket placed on tooth due to position of the tooth at that point in time (tooth turned 90 degrees). Two teeth could be excluded from the initial bonding if an expander is used. 6. Subject will have more than 25% of the total number of brackets bonded to a non-enamel surface (e.g., restoration). 7. Subject has developmental abnormalities of the enamel (e.g., hypoplasia, moderate to severe fluorosis). 8. Subject has erupted 3rd molars in the opinion of the investigator have impact on the treatment duration. 9. Subject is, in the opinion of the investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Broadbent Orthodontics

    Ogden, Utah, 84414, United States

  • Larson Orthodontics

    Altoona, Wisconsin, 54720, United States

  • Nadeau Orthodontics

    Kennebunk, Maine, 04043, United States

  • Northwell Health Physician Partners Dental Medicine at Great Neck

    Great Neck, New York, 11023, United States

  • The Orthodontic Studio

    Glendale, California, 91208, United States

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