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Clinical Trials/NCT06167278
NCT06167278
Recruiting
Not Applicable

INDIRECT BONDING ACCURACY OF TWO DIFFERENT 3D PRINTED DIGITAL TRANSFER TRAYS: A RANDOMIZED CLINICAL TRIAL

Marmara University1 site in 1 country30 target enrollmentJune 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthodontics
Sponsor
Marmara University
Enrollment
30
Locations
1
Primary Endpoint
Accuracy of bracket position
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
February 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • Patients needing treatment with extraction, having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth.

Outcomes

Primary Outcomes

Accuracy of bracket position

Time Frame: 15 days

Angular (torque, tip, angulation) and linear (mesiodistal, buccolingual, occlusogingival) differences will be compared between the bonded intraoral scans taken immediately after IDB and the virtually bracketed model prepared in the Ortho Analyzer software (3Shape A/S, Copenhagen, Denmark) using the open source GOM inspect software (GOM GmbH, Braunschweig, Germany).

Study Sites (1)

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