Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05193708 |
Other study ID # |
777 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.