Indirect Bonding Accuracy of 3D Printed Digital Transfer Trays

NCT06167278 | Unknown

• 1 other identifier: Marmaraortho1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

3D printed indirect bonding transfer tray

Outcome Measures

Primary Outcomes (1)

• Accuracy of bracket position

  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).

  15 days

Study Arms (2)

Shell tray group

EXPERIMENTAL

Other: Indirect bonding with two different digital bracket bonding transfer tray

Bar tray group

EXPERIMENTAL

Other: Indirect bonding with two different digital bracket bonding transfer tray

Interventions

Indirect bonding with two different digital bracket bonding transfer tray 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; Shell tray group

Eligibility Criteria

• Age: 17 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: June 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: February 15, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)