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

NCT ID: NCT05193708

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-22

Study Completion Date

2025-04-22

Brief Summary

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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

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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.

Conditions

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Dental Bonding Orthodontic Brackets Indirect Bonding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Digital Indirect bonding

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

Group Type ACTIVE_COMPARATOR

Windowed Bonding

Intervention Type DEVICE

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

Windowed Bonding technique

3D printed guide with windows for positioning the bracket

Group Type EXPERIMENTAL

Digital Indirect bonding tray

Intervention Type DEVICE

Vacuum formed on a 3d printer cast with brackets

Interventions

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Windowed Bonding

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

Intervention Type DEVICE

Digital Indirect bonding tray

Vacuum formed on a 3d printer cast with brackets

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelhady Nasef

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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777

Identifier Type: -

Identifier Source: org_study_id

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