Clinical trial NCT06266130: Digital Bonding vs. Direct Bonding Study
Official title: A Randomized, Controlled, Two-arm Clinical Study to Evaluate Clinical Efficiency of 3MTM Digital Bonding Versus Direct Bonding
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Orthodontic Brackets
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 178
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject is 12 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).
7. Subject has an Angle Class I or Class II (up to 3mm) molar and canine 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)
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.
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 outcomes:
measure: Prep-and-bonding time
timeFrame: From the start of teeth preparation to the completion of bonding procedures.
Secondary outcomes:
measure: Number of adjustment visits to complete treatment
timeFrame: Treatment duration from the completion of bonding visit to the bracket removal visit (18-24 months)
measure: Overall chair time
timeFrame: From initial bonding visit to the end of bracket removal visit.
Other outcomes:
Locations:
city: Glendale
country: United States
facility: The Orthodontic Studio
state: California
city: Kennebunk
country: United States
facility: Nadeau Orthodontics
state: Maine
city: Great Neck
country: United States
facility: Northwell Health Physician Partners Dental Medicine at Great Neck
state: New York
city: Ogden
country: United States
facility: Broadbent Orthodontics
state: Utah
city: Altoona
country: United States
facility: Larson Orthodontics
state: Wisconsin
Study officials:
affiliation: Solventum Orthodontics Corporation
name: Lori Leitheiser
role: STUDY_CHAIR
References: