Clinical trial NCT06167278: Indirect Bonding Accuracy of 3D Printed Digital Transfer Trays
Official title: INDIRECT BONDING ACCURACY OF TWO DIFFERENT 3D PRINTED DIGITAL TRANSFER TRAYS: A RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontics
Bracket Bonding
Indirect Bonding
Digital Indirect Bonding Transfer Tray
Accuracy of Bracket Positioning
Keywords: 3D printed indirect bonding transfer tray
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Accuracy of bracket position
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References: