Orthodontic BracketsNCT06266130
Digital Bonding vs. Direct Bonding Study
A study testing Treatment Group Digital Bonding Tray in people with Orthodontic Brackets, run by Solventum Orthodontics Corporation at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Brackets
- What is being tested?
- Treatment Group Digital Bonding Tray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Mar 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject is 11 years of age or older.
- 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
- Subject is able and willing to be available for all scheduled study visits.
- The Subject is treatment-planned for required comprehensive orthodontic treatment for both arches using brackets.
- 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.
- 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).
Show all 11Show fewer
- Subject has an Angle Class I or Class II 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 bracket placement.
- The Subject is anticipated to complete treatment within 18 to 24 months.
Who cannot join
- 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 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.
- Subject will have more than 25% of the total number of brackets bonded to a non-enamel surface (e.g., restoration).
Show all 9Show fewer
- Subject has developmental abnormalities of the enamel (e.g., hypoplasia, moderate to severe fluorosis).
- Subject has erupted 3rd molars in the opinion of the investigator have impact on the treatment duration.
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Larson Orthodontics
Altoona, Wisconsin, 54720
The Orthodontic Studio
Glendale, California, 91208
Northwell Health Physician Partners Dental Medicine at Great Neck
Great Neck, New York, 11023
Nadeau Orthodontics
Kennebunk, Maine, 04043
Broadbent Orthodontics
Ogden, Utah, 84414
About this study
Official title: A Randomized, Controlled, Two-arm Clinical Study to Evaluate Clinical Efficiency of 3MTM Digital Bonding Versus Direct Bonding
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.
Read the 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.
- Conditions
- Orthodontic Brackets
- Being tested
- Treatment Group Digital Bonding Tray, Control Group Direct Bonding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Group Digital Bonding TrayDevice
Also called 3M 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 BondingDevice
Also called Direct Bonding method
The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Other | Digital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray. Receives: Device: Treatment Group Digital Bonding Tray |
| Control Group | Active comparator | Direct bonding method. Brackets will be bonded to each subject's teeth by direct placement. Receives: Device: Control Group Direct Bonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prep-and-bonding time
The duration (in minutes) for preparation of teeth, bracket positioning and bonding onto teeth
Measured: From the start of teeth preparation to the completion of bonding procedures.
Secondary outcomes (2)
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).
Measured: Treatment duration from the completion of bonding visit to the bracket removal visit (18-24 months)
Overall chair time
Sum of chair time for the initial application, necessary follow-up visits, and removal of treatment (in minutes).
Measured: From initial bonding visit to the end of bracket removal visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start25 Mar 2024
- Primary completion23 Jun 2026
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic BracketsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum Orthodontics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lori Leitheiser, Study chair, Solventum Orthodontics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266130
- Sponsor's protocol ID
- EM-11-050087
- Status last verified
- Jul 2026
- First submitted
- 12 Feb 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Two-arm Clinical Study to Evaluate Clinical Efficiency of 3MTM Digital Bonding Versus Direct Bonding
- ClinicalTrials.gov ID
- NCT06266130
- Acronym / sponsor ID
- EM-11-050087
- Conditions
- Orthodontic Brackets
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Solventum Orthodontics CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Other | Device: Treatment Group Digital Bonding TrayDigital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray. |
| Control Group | Active comparator | Device: Control Group Direct BondingDirect bonding method. Brackets will be bonded to each subject's teeth by direct placement. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is 11 years of age or older.
- 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
- Subject is able and willing to be available for all scheduled study visits.
- The Subject is treatment-planned for required comprehensive orthodontic treatment for both arches using brackets.
- 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.
Key exclusion criteria (9 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment Group Digital Bonding TrayAlso: 3M Digital Bonding TrayThe 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. | Device | Treatment Group |
| Control Group Direct BondingAlso: Direct Bonding methodThe orthodontic brackets will be applied to Subject's teeth individually with direct bonding method. | Device | Control Group |
Primary outcome
Prep-and-bonding time
Time frame: 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
2 secondary outcomes
Number of adjustment visits to complete treatment
Time frame: Treatment duration from the completion of bonding visit to the bracket removal visit (18-24 months)
Overall chair time
Time frame: From initial bonding visit to the end of bracket removal visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. No plan to share IPD to other researchers.
Related trials for Orthodontic Brackets
Active, not recruiting
Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin
Bracket Failure, Bracket Bonding
Enrolling by invitation
Comparison of Orthodontic Bracket Bond Failure Using Acid Etching With or Without Sandblasting
Dental Etching, Dental Bonding
Not yet recruiting
Effect of BG Versus RI on the Depth of WSL
White Spot Lesions
Recruiting
Digital vs. Conventional Indirect Bonding.
Malocclusion
Not yet recruiting
A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding
White Spot Lesions, Enamel Demineralization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Leitheiser study chair
Solventum Orthodontics Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Group Digital Bonding Tray in people with Orthodontic Brackets, run by Solventum Orthodontics Corporation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prep-and-bonding time (time frame: From the start of teeth preparation to the completion of bonding procedures.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.