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

October 22, 2022 updated by: Ahmed Abdelhady Nasef, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Digital Indirect bonding
An indirect bonding tray will be fabricated from a 3D printed model
Device: Windowed Bonding
A 3D printed tray/guide with open window for the orthodontic brackets
Experimental: Windowed Bonding technique
3D printed guide with windows for positioning the bracket
Device: Digital Indirect bonding tray
Vacuum formed on a 3d printer cast with brackets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bonding accuracy
Time Frame: After bonding immediately
Deterring the accuracy of bracket position
After bonding immediately

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 22, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 777

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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