Phase
Condition
N/ATreatment
Control Group Direct Bonding
Treatment Group Digital Bonding Tray
Clinical Study ID
Ages > 12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is 12 years of age or older.
Subject is able and willing to provide their own informed Assent AND Subject orLegal Authorized Representative (LAR) is able and willing to sign the InformedConsent Form
Subject is able and willing to be available for all scheduled study visits.
The Subject is treatment-planned for required comprehensive orthodontic treatmentfor both arches using brackets.
Subject's current orthodontic treatment plan does not include extractions,orthognathic surgery, post-orthodontic restorative treatment (with the exception ofminor spaces for tooth shaping post-orthodontic treatment), or temporary anchoragedevices.
Subject has all permanent teeth erupted (dentition including second molars).
Subject has an Angle Class I or Class II (up to 3mm) molar and canine relationships.
The Subject has mild to moderate crowding (crowding less than 5 mm in each arch)
Subject has an overbite measuring between -1 mm (open bite) and 5 mm (deep bite).
The Subject's intra-oral scan must have been taken within 90 days of bracketplacement.
The Subject is anticipated to complete treatment within 18 to 24 months.
Exclusion
Exclusion Criteria:
Subject has a history of adverse reaction to any materials used in this study.
Subject is pregnant or breast feeding.
Subject has advanced periodontal disease.
Subject has non-movable teeth (e.g., implants, bridges, ankylosed teeth).
Subject has more than 1 tooth excluded from the initial bonding (not including 2ndmolars), e.g., no bracket placed on tooth due to position of the tooth at that pointin time (tooth turned 90 degrees)
Subject will have more than 25% of the total number of brackets bonded to anon-enamel surface (e.g., restoration).
Subject has developmental abnormalities of the enamel (e.g., hypoplasia, moderate tosevere fluorosis).
Subject has erupted 3rd molars.
Subject is, in the opinion of the investigator, unsuitable for enrollment in thestudy for reasons other than those specified in the above exclusion criteria.
Study Design
Study Description
Connect with a study center
The Orthodontic Studio
Glendale, California 91208
United StatesSite Not Available
Nadeau Orthodontics
Kennebunk, Maine 04043
United StatesSite Not Available
TDR Specialist in Orthodontics
Birmingham, Michigan 48009
United StatesSite Not Available
Northwell Health Physician Partners Dental Medicine at Great Neck
Great Neck, New York 11023
United StatesSite Not Available
Broadbent Orthodontics
Ogden, Utah 84414
United StatesSite Not Available
Larson Orthodontics
Altoona, Wisconsin 54720
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.