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

NCT05193708 | Completed DMC

• 1 other identifier: 777
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Bonding; Orthodontic Brackets; Indirect Bonding

Keywords

digital indirect; windowed bonding tray

Outcome Measures

Primary Outcomes (1)

• Bonding accuracy

  Deterring the accuracy of bracket position

  After bonding immediately

Secondary Outcomes (1)

• Bonding time

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

Study Arms (2)

Digital Indirect bonding

ACTIVE COMPARATOR

An indirect bonding tray will be fabricated from a 3D printed model

Device: Windowed Bonding

Windowed Bonding technique

EXPERIMENTAL

3D printed guide with windows for positioning the bracket

Device: Digital Indirect bonding tray

Interventions

Windowed Bonding DEVICE

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

Digital Indirect bonding

Digital Indirect bonding tray DEVICE

Vacuum formed on a 3d printer cast with brackets

Windowed Bonding technique

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: October 22, 2022
• Primary Completion: January 1, 2025
• Study Completion: April 22, 2025
• Last Updated: June 27, 2025

Record last verified: 2024-08

Locations

EG (1)