Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05193708
Enrollment
14
Registered
2022-01-18
Start date
2022-10-22
Completion date
2025-04-22
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Bonding, Indirect Bonding, Orthodontic Brackets

Keywords

digital indirect, windowed bonding tray

Brief summary

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.

Detailed description

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.

Interventions

DEVICEWindowed Bonding

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

DEVICEDigital Indirect bonding tray

Vacuum formed on a 3d printer cast with brackets

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bonding accuracyAfter bonding immediatelyDeterring the accuracy of bracket position

Secondary

MeasureTime frameDescription
Bonding timeTime begins starting from etching procedure till the final bracket cured, this will be measured in minutes (~ 20 minutes)Calculating the time of bonding

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026