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

Dental Bonding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193708
• Other study ID #: 777
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2022
• Est. completion date: May 2023

Study information

• Verified date: October 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: May 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Bonding

Intervention

Device:
• Windowed Bonding
A 3D printed tray/guide with open window for the orthodontic brackets
• Digital Indirect bonding tray
Vacuum formed on a 3d printer cast with brackets

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bonding accuracy	Deterring the accuracy of bracket position	After bonding immediately
Secondary	Bonding time	Calculating the time of bonding	Time begins starting from etching procedure till the final bracket cured, this will be measured in minutes (~ 20 minutes)