Clinical Investigation of the Transfer Accuracy of Semi-Digital and Fully Digital Indirect Bonding Trays

NCT07318857 | Completed

• 1 other identifier: SU-ORTO-2542
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical study compares the transfer accuracy of semi-digital and fully digital indirect bonding trays in orthodontic treatment. Thirty-two patients were randomly divided into two groups to receive brackets bonded with either semi-digital trays (thermoformed on 3D printed models) or fully digital trays (directly 3D printed). The primary outcome measures are linear and angular deviations between the virtually planned and actual clinical bracket positions, analyzed using 3D superimposition techniques.

Conditions

Indirect Bonding

Outcome Measures

Primary Outcomes (2)

• Linear Transfer Accuracy

  Linear deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software. Unit of Measure: Millimeters

  Immediately after the bonding procedure (Day 1)

• Angular Transfer Accuracy

  Angular deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software. Unit of Measure: Degrees

  Immediately after the bonding procedure (Day 1)

Study Arms (2)

Semi-Digital Transfer Tray Group

ACTIVE COMPARATOR

Indirect bonding using transfer trays prepared by thermoforming over 3D printed models

Procedure: Semi-Digital Indirect Bonding

Fully Digital Transfer Tray Group

EXPERIMENTAL

Indirect bonding using directly 3D printed transfer trays designed in CAD software

Procedure: Fully Digital Indirect Bonding

Interventions

Semi-Digital Indirect Bonding PROCEDURE

Bonding brackets using thermoformed transfer trays.

Semi-Digital Transfer Tray Group

Fully Digital Indirect Bonding PROCEDURE

Bonding brackets using 3D printed transfer trays.

Fully Digital Transfer Tray Group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 12-25 years in permanent dentition
• Had a mild irregularity (≤ 3mm)
• Requiring comprehensive fixed orthodontic treatment and had no previous orthodontic therapy
• Not having malformed, excessively rotated, large restorations or missing teeth in the upper arch

You may not qualify if:

• Inadequate oral hygiene
• Had severe crowding
• Systemic or craniofacial anomalies

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, Selcuk University

Konya, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 6, 2026
• Study Start: June 15, 2023
• Primary Completion: May 21, 2024
• Study Completion: June 24, 2024
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

TU (1)