Optimization of Orthodontic Bracket Placement by Using Two Different Protocols of Digitally Aided Bonding

May 8, 2026 updated by: Sarah Alaaeldin Ahmed Fathy Elsaied, Alexandria University

Optimization of Orthodontic Bracket Placement by Using Two Different Protocols of Digitally Aided Bonding (Split-Mouth Randomized Controlled Clinical Trial)

The aim of this study is to compare the accuracy of orthodontic bracket positioning using two different protocols of digitally aided bonding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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

  • Egypt
      • Alexandria, Egypt
        • Alexandria 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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with permanent dentition starting orthodontic treatment requiring vestibular fixed orthodontic appliance according to treatment needs.
  • Fully erupted set of teeth (except for the second and third molars).
  • Mild to moderate crowding.
  • Good oral hygiene.

Exclusion Criteria:

  • Any medical or dental conditions that may impede orthodontic treatment.
  • Patients with severe crowded or rotated teeth, or partially erupted teeth that will hinder the proper positioning of the brackets or bonding trays.
  • Patients with any enamel abnormalities, hypoplastic enamel, white spot lesions.
  • Presence of large restorations or carious teeth.
  • Presence of supernumerary or impacted teeth or tooth agenesis.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indirect bonding group
Other: 3D printed indirect bonding trays
Intraoral scan of participants' upper dentition will be obtained. Digital stereolithography models will be used for virtual bracket positioning on software. The digital setup of the brackets will be used for designing the customized indirect bonding transferring tray for one quadrant of the upper arch of each patient.
Experimental: Guided direct bonding group
Other: 3D printed guiding direct bonding trays
Intraoral scan of participants' upper dentition will be obtained. Digital stereolithography models will be used for virtual bracket positioning on software. The digital setup of the brackets will be used for designing the customized guiding direct bonding tray for the other quadrant of the upper arch of each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bracket Placement Accuracy
Time Frame: Immediately after bonding
Measured as the linear and angular deviation between the virtually planned and actual bracket positions using 3D superimposition technique of the digital setup model and intraoral scan after bonding.
Immediately after bonding

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate Bracket Failure
Time Frame: Immediately after bonding
Immediate bracket failure will be assessed for each quadrant during the removal of the bonding trays at the bonding appointment.
Immediately after bonding

Collaborators and Investigators

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

Sponsor

Alexandria 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)

March 31, 2026

Primary Completion (Actual)

April 15, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1129-08/2025

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

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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