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OpenTrials
Completed

NCT Number: NCT05193708

Comparison of Bracket Bonding Variables Using 3D Printed Bonding Guide Versus Digital Indirect Bonding

The windowed direct-indirect bonding is a new bonding technique that could provide a simple and cheap method for fast and precise brackets bonding. There are still not enough studies to evaluate the effectiveness of this method in terms of accuracy, bonding time, bonding failure and cost.

This study is designed to answer these questions and compare the forementioned bonding technique with digital indirect bonding and finally provide the clinician a recommendation on the best bonding technique. This study introduces as well a new method of fabrication of the windowed template using Fusion Deposition Modeling (FDM) 3D printing technology.

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Key information

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

About this study

This study will compare two bonding techniques, the windowed bonding technique and digital indirect bonding. They will be compared regarding accuracy, bonding time, bonding failure and cost. Patients will be selected according to the eligibility criteria, random sequence generation and blind allocation will be performed. ( A randomized clinical trial). Patients will be allocated to one of the groups either the windowed bonding or the digital indirect bonding.

Both groups will undergo similar steps initially. First, the patient's teeth will be digitized using an intraoral scanner. Then using 3 shape software, the model will be prepared and brackets will be positioned virtually on the 3D models. Then, in the windowed bonding technique, the windowed tray will be designed and later 3D printed, while in the digital indirect technique the model with the brackets will be 3D printed and a tray will be fabricated on the model manually.

After the fabrication of the tray, the brackets will be transferred to the patient using the tray or directly bonded using the windowed tray guide.

The patient's teeth will be scanned after bonding and this 3D model will be compared with the initial brackets setup that was made previously on the software.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - Patients who need Orthodontic treatment with full dentition excluding 3rd molars.
  • Fully erupted 5-5 with normal anatomy.
  • The patient's age range is from 12 to 60 years of age.
  • Both extraction and non-extraction cases are included.

Exclusion criteria

  • - Patients with caries, fluorosis, enamel hypoplasia, restorations, or fractures.
  • Patients with severe rotations.

Treatment and study plan

Windowed Bonding

Device

A 3D printed tray/guide with open window for the orthodontic brackets

Digital Indirect bonding tray

Device

Vacuum formed on a 3d printer cast with brackets

Primary outcomes

  1. Bonding accuracy

    Time frame: After bonding immediately

    Deterring the accuracy of bracket position

Secondary outcomes

  1. Bonding time

    Time frame: Time begins starting from etching procedure till the final bracket cured, this will be measured in minutes (~ 20 minutes)

    Calculating the time of bonding

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison of Bracket Bonding Variables Using Bonding Guide 3D Printed With Fusion Deposition Modeling Versus Digital Indirect Bonding. A Randomized Controlled Trial.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2022
Registry last updated
Jun 27, 2025

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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