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Digital Bonding vs. Direct Bonding Study

NCT06266130 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-04-28

No results posted yet for this 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.

Conditions

  • Orthodontic Brackets

Interventions

DEVICE

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.

DEVICE

Control Group Direct Bonding

The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method.

Sponsors & Collaborators

  • Solventum Orthodontics Corporation

    lead INDUSTRY

Principal Investigators

  • Lori Leitheiser · Solventum Orthodontics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2026-08-31
Completion
2028-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266130 on ClinicalTrials.gov