Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06167278 |
| Other study ID # |
Marmaraortho1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2023 |
| Est. completion date |
February 15, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this study is to compare the bracket transfer accuracy of two frequently used 3D
printed indirect bonding trays.
This is an interventional study. Participants have 3-6mm crowding without tooth loss and
deformity. It is planned to be 2 groups in the study. Each group will include 15
participants. Indirect bonding will be applied with shell and bar designs that are frequently
used. Brackets will be bonded from second premolar to other side's second premolar of upper
and lower jaw. Bracket transfer accuracy of two different trays will be compared with planned
position and each other.
Description:
There are planned to be 2 groups in the study. Each group will include 15 participants. The
patients who apply for orthodontic treatment will be included in this study. inclusion
criteria: patients between age of 17-30, in complete permanent dentition, have mild to
moderate (3-6mm) crowding according to Little's irregularity index, good oral hygiene and
periodontal health. The exclusion criteria were patients needing treatment with extraction,
having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth. Informed and
written consent forms will be obtained from each patient for experimentation.
Intraoral scans with the 3Shape device (3Shape TRIOS, Copenhagen, Denmark) are routinely
recorded from the patients whose treatment will begin before treatment. Bracket positions
will be adjusted on the scan images using 3Shape OrthoAnalyzer 2015 software. Then, the
bracket model will be transferred to the Appliance Designer software program, 2 types of
transfer trays will be designed and produced with the 3D printer in the clinic. Patients will
be indirectly bracketed with the produced transfer trays and intraoral scan recordings will
be taken again after bracketing. This image and the images where the brackets are placed in
the software will be overlaid with the GOM Inspect software (GOM GmbH, Braunschweig, Germany)
and the deviations will be calculated for both transfer trays and the differences will be
compared.
The measurements to be performed are: linear: mesiodistal, buccolingual, incisogingival;
angular: torque, angulation, rotation. Measurements will be calculated separately for all
teeth.
None of these steps deviate from the routine treatment protocol and none of the procedures
are harmful or invasive for the patient.
