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NCT Number: NCT07692880

Digital vs. Conventional Indirect Bonding.

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontic Clinic, Division of Dentistry, Careggi University Hospital

Florence, Italy

Location status: Recruiting

Location contact

Lorenzo Franchi

CONTACT

[email protected]

+390557945602

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

digital indirect bonding technique

Device

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

conventional indirect bonding technique

Device

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

Primary outcomes

  1. Time required to complete bracket bonding procedures, measured in minutes

    Time frame: During procedure (from the beginning of bracket bonding to completion of bracket placement)

    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.

Secondary outcomes

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

    Time frame: 1 month after placement of the fixed orthodontic appliance

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Franchi

CONTACT

[email protected]

+390557945602

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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