New digital tray aims to speed up braces placement
NCT ID NCT06266130
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
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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
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138 people
The number who actually took part.
- Started
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Mar 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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11 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Broadbent Orthodontics
Ogden, Utah, 84414, United States
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Larson Orthodontics
Altoona, Wisconsin, 54720, United States
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Nadeau Orthodontics
Kennebunk, Maine, 04043, United States
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Northwell Health Physician Partners Dental Medicine at Great Neck
Great Neck, New York, 11023, United States
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The Orthodontic Studio
Glendale, California, 91208, United States
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