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Indirect Bonding Accuracy of 3D Printed Digital Transfer Trays

NCT ID: NCT06167278

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-02-15

Brief Summary

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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

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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.

Conditions

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Orthodontics Bracket Bonding Indirect Bonding Digital Indirect Bonding Transfer Tray Accuracy of Bracket Positioning

Keywords

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3D printed indirect bonding transfer tray

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Shell tray group

Group Type EXPERIMENTAL

Indirect bonding with two different digital bracket bonding transfer tray

Intervention Type OTHER

To achieve more precise and predictable result is the common aim in contemporary treatment. Digital indirect bonding (IDB) is used for this purpose in orthodontic treatment. The aim of this study is to compare the transfer accuracy of two different IDB trays.

Digital IDB was performed on a total of 30 patients, using one of the two designs: shell and bar trays; with 15 patients in each group. Trays were designed with the Appliance Designer software (3Shape A/S, Copenhagen, Denmark) as shell and bar types.

Bar tray group

Group Type EXPERIMENTAL

Indirect bonding with two different digital bracket bonding transfer tray

Intervention Type OTHER

To achieve more precise and predictable result is the common aim in contemporary treatment. Digital indirect bonding (IDB) is used for this purpose in orthodontic treatment. The aim of this study is to compare the transfer accuracy of two different IDB trays.

Digital IDB was performed on a total of 30 patients, using one of the two designs: shell and bar trays; with 15 patients in each group. Trays were designed with the Appliance Designer software (3Shape A/S, Copenhagen, Denmark) as shell and bar types.

Interventions

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Indirect bonding with two different digital bracket bonding transfer tray

To achieve more precise and predictable result is the common aim in contemporary treatment. Digital indirect bonding (IDB) is used for this purpose in orthodontic treatment. The aim of this study is to compare the transfer accuracy of two different IDB trays.

Digital IDB was performed on a total of 30 patients, using one of the two designs: shell and bar trays; with 15 patients in each group. Trays were designed with the Appliance Designer software (3Shape A/S, Copenhagen, Denmark) as shell and bar types.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Gülden Karabiber, DDS

Role: primary

Other Identifiers

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Marmaraortho1

Identifier Type: -

Identifier Source: org_study_id