Digital vs. Conventional Indirect Bonding.

Comparison of Indirect Bonding of Orthodontic Brackets Using Digital Versus Conventional Technology: A Randomized Controlled Trial on Bonding Time and Bracket Failure

This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques for fixed orthodontic bracket placement in adolescent patients requiring treatment in both dental arches.

Each participant will receive both bonding techniques, with allocation of the digital and conventional indirect bonding procedures to the upper or lower arch determined by randomization. The study will evaluate the time required to complete bracket bonding procedures and the early clinical performance of the two techniques, assessed by bracket failure within the first month after appliance placement.

Study Overview

• Status: Recruiting
• Conditions: Malocclusion
• Intervention / Treatment: Device: digital indirect bonding technique; Device: conventional indirect bonding technique

Detailed Description

Indirect bonding has been proposed as an alternative to direct bonding for the placement of orthodontic brackets, with potential advantages in terms of clinical efficiency, bracket positioning, and patient comfort. In recent years, computer-aided three-dimensional design and manufacturing methods have enabled the production of digital transfer trays for indirect bonding, offering a potentially more standardized workflow compared with conventional laboratory-based procedures.

This randomized split-mouth clinical trial will compare digital and conventional indirect bonding techniques in patients undergoing fixed orthodontic treatment in both the upper and lower arches. Each participant will receive both techniques, with the allocation of the digital and conventional bonding procedures to the upper or lower arch determined by randomization.

In the digital indirect bonding procedure, transfer trays will be produced using a digital workflow and brackets will be bonded using a pre-coated adhesive system. In the conventional indirect bonding procedure, transfer trays will be produced using a standard laboratory workflow and brackets will be bonded using a conventional orthodontic adhesive system.

The study will assess the procedural efficiency of the two techniques by recording the time required to complete the bracket bonding procedure. Early clinical performance will be evaluated by recording bracket failures during the first month of orthodontic treatment. All procedures and follow-up assessments will be performed in a clinical orthodontic setting.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorenzo Franchi; Phone Number: +390557945602; Email: lorenzo.franchi@unifi.it

Study Locations

• Italy
  • Florence, Italy
    • Recruiting
    • Orthodontic Clinic, Division of Dentistry, Careggi University Hospital
    • Contact: Lorenzo Franchi; Phone Number: +390557945602; Email: lorenzo.franchi@unifi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 12 to 18 years requiring fixed orthodontic treatment on both upper and lower arches
• Presence of full permanent dentition, including erupted second molars

Exclusion Criteria:

• Presence of dental anomalies in number (supernumerary or missing teeth) in either arch
• Orthodontic treatment plans involving tooth extractions in either arch
• Nickel allergy
• History of cleft lip and/or palate
• Craniofacial syndromes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch; Participants assigned to this arm will receive digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch.	Device: digital indirect bonding technique; Fixed orthodontic appliance will be bonded using a digital indirect bonding technique; Device: conventional indirect bonding technique; Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique
Active Comparator: Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch; Participants assigned to this arm will receive conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch.	Device: digital indirect bonding technique; Fixed orthodontic appliance will be bonded using a digital indirect bonding technique; Device: conventional indirect bonding technique; Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required to complete bracket bonding procedures, measured in minutes	The time required to complete the bracket bonding procedure will be measured in minutes for each participant, from the beginning of the bonding procedure to completion of bracket placement, using the assigned adhesive system.	During procedure (from the beginning of bracket bonding to completion of bracket placement)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bracket failure rate within the first month of orthodontic treatment assessed by clinical examination	Bracket failure will be assessed by clinical examination and recorded as the number of brackets detached from the tooth surface within the first month after placement of the fixed orthodontic appliance.	1 month after placement of the fixed orthodontic appliance

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2025
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): August 24, 2026

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: LF17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No