Digital vs. Conventional Indirect Bonding.

NCT07692880 | Recruiting

• 1 other identifier: LF17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bracket failure rate within the first month of orthodontic treatment assessed by clinical examination

  1 month after placement of the fixed orthodontic appliance

Study Arms (2)

Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch

EXPERIMENTAL

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; Device: conventional indirect bonding technique

Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch

ACTIVE COMPARATOR

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; Device: conventional indirect bonding technique

Interventions

digital indirect bonding technique DEVICE

Fixed orthodontic appliance will be bonded using a digital indirect bonding technique

Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch; Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch

conventional indirect bonding technique DEVICE

Fixed orthodontic appliance will be bonded using a conventional indirect bonding technique

Conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch; Digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Orthodontic Clinic, Division of Dentistry, Careggi University Hospital

Florence, Italy

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Lorenzo Franchi

CONTACT

+390557945602; lorenzo.franchi@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized split-mouth design. Each participant will receive both digital and conventional indirect bonding techniques. Participants will be randomized to one of two allocation sequences: digital indirect bonding in the upper arch and conventional indirect bonding in the lower arch, or conventional indirect bonding in the upper arch and digital indirect bonding in the lower arch.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: July 9, 2026
• Study Start: September 3, 2025
• Primary Completion: July 20, 2026
• Study Completion (Estimated): August 24, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)