Treatment Group Digital Bonding TrayControl Group Direct Bonding
Treatment Group Digital Bonding Tray: The Digital Bonding Tray is used in orthodontic treatment of misaligned teeth and provides a method to accurately position orthodontic brackets onto a patient's teeth simultaneously during a single procedure.
Control Group Direct Bonding: The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method.
Study summary
This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets.
Eligibility
Sex
ALL
Min age
11 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Prep-and-bonding time — From the start of teeth preparation to the completion of bonding procedures. The duration (in minutes) for preparation of teeth, bracket positioning and bonding onto teeth
Trial sites (5)
Facility
City
Region
Status
The Orthodontic Studio
Glendale
California
Nadeau Orthodontics
Kennebunk
Maine
Northwell Health Physician Partners Dental Medicine at Great Neck
Great Neck
New York
Broadbent Orthodontics
Ogden
Utah
Larson Orthodontics
Altoona
Wisconsin
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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