Digital Bonding vs. Direct Bonding Study

Conditions

• Orthodontic Brackets

Eligibility Criteria

Sex

ALL

Age

11 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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.
• Control Group Direct Bonding — DEVICE
  The orthodontic brackets will be applied to Subject's teeth individually with direct bonding method.

Study Details

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.

Key Dates

Start date

Mar 25, 2024

Status verified

Apr 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2028

Study Design

Enrollment

178 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Other: Treatment Group
  Digital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray.
• Active Comparator: Control Group
  Direct bonding method. Brackets will be bonded to each subject's teeth by direct placement.

Primary Outcome Measure

Prep-and-bonding time [ Time Frame: From the start of teeth preparation to the completion of bonding procedures. ]

Locations (5)

Find similar trials in Glendale, CA