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

January 5, 2026 updated by: Ramazan Emre Karakoç, Selcuk University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Konya, Turkey (Türkiye)
        • Department of Orthodontics, Faculty of Dentistry, Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Semi-Digital Transfer Tray Group
Indirect bonding using transfer trays prepared by thermoforming over 3D printed models
Procedure: Semi-Digital Indirect Bonding
Bonding brackets using thermoformed transfer trays.
Experimental: Fully Digital Transfer Tray Group
Indirect bonding using directly 3D printed transfer trays designed in CAD software
Procedure: Fully Digital Indirect Bonding
Bonding brackets using 3D printed transfer trays.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear Transfer Accuracy
Time Frame: Immediately after the bonding procedure (Day 1)

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
Time Frame: Immediately after the bonding procedure (Day 1)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Actual)

May 21, 2024

Study Completion (Actual)

June 24, 2024

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • SU-ORTO-2542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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