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

Study Overview
=================
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.

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

Conditions
-----------------
Dental Bonding, Orthodontic Brackets, Indirect Bonding

Intervention / Treatment
-----------------
* Device: Windowed Bonding
* Device: Digital Indirect bonding tray


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
digital indirect, windowed bonding tray