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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.
Traditional Direct bonding bonds each bracket tooth by tooth individually. 3M digital bonding tray is a custom device which can have brackets pre-loaded according to the pre-determined placement by orthodontist prior to patient's arrival to the bonding appointment. This new bonding method allows orthodontist to bond an entire arch of brackets at once, significantly reducing chair time for patients. It is anticipated that patients in digital bonding group have shorter time spent for bonding brackets, less chair time, and fewer adjustment visits than those in direct bonding group.
The treatment arm utilizes a combination of the Digital Bonding Tray and pre adhesive-coated Brackets.
The study control arm will utilize the site's standard of care brackets (pre-adhesive-coated or non-coated) directly and individually applied to teeth. Roughly half of sites will utilize pre-coated brackets and the remaining sites will use uncoated brackets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Other | Digital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray. |
|
| Control Group | Active Comparator | Direct bonding method. Brackets will be bonded to each subject's teeth by direct placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Group Digital Bonding Tray | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prep-and-bonding time | The duration (in minutes) for preparation of teeth, bracket positioning and bonding onto teeth | From the start of teeth preparation to the completion of bonding procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adjustment visits to complete treatment | Adjustment visits (visits with a bracket repositioning, arch wire compensation bend, and/or rebonding of a failed bracket). | Treatment duration from the completion of bonding visit to the bracket removal visit (18-24 months) |
| Overall chair time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Leitheiser | Solventum Orthodontics Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Orthodontic Studio | Glendale | California | 91208 | United States | ||
| Nadeau Orthodontics |
No plan to share IPD to other researchers.
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There are two groups, treatment group (digital bonding) and control group (direct bonding). Subjects will be enrolled and randomized into treatment or control group at each orthodontic practice.
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Due to the nature of the devices, Investigator blinding is not feasible for the study.
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|
| Control Group Direct Bonding | Device | The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method. |
|
|
Sum of chair time for the initial application, necessary follow-up visits, and removal of treatment (in minutes). |
| From initial bonding visit to the end of bracket removal visit. |
| Kennebunk |
| Maine |
| 04043 |
| United States |
| Northwell Health Physician Partners Dental Medicine at Great Neck | Great Neck | New York | 11023 | United States |
| Broadbent Orthodontics | Ogden | Utah | 84414 | United States |
| Larson Orthodontics | Altoona | Wisconsin | 54720 | United States |