Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays

Transfer Accuracy of Indirectly Bonded Orthodontic Attachments With Vacuum Formed and Silicone Transfer Trays

The aim of this study is to comparatively investigate the performances of two different and widely used transfer trays during indirect bonding of the orthodontic braces.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Device: Indirect bonding

Detailed Description

The aim of the study is to compare the accuracy of orthodontic bracket and tube transfer between double layer silicone and double layer vacuum formed trays. The sample included 368 attachments bonded in 16 patients. Each patient received one silicone and one vacuum formed tray which were randomly allocated to provide 8 trays of each type for the upper and lower arches. 3D scan data and local best-fit alignments were used to calculate the translational and rotational movements of the orthodontic attachments. Chi-square and Mann-Whitney U tests were used to compare transfer accuracy and success between the groups.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65080
    • Cihan Aydoğan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The presence of indication for both arches to be bonded in the same appointment

Exclusion Criteria:

• Presence of restorations, hypoplasia or decalcification on vestibular tooth surfaces
• Abnormal crown morphology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silicone; Indirect bonding performed with the silicone trays	Device: Indirect bonding; Indirect bonding is the technique where orthodontic appliances are first placed on a model of the patient and then transferred to the patient using some kinf of trays
Active Comparator: Vacuum formed; Indirect bonding performed with the vacuum formed trays	Device: Indirect bonding; Indirect bonding is the technique where orthodontic appliances are first placed on a model of the patient and then transferred to the patient using some kinf of trays

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfer accuracy (composite outcome) in milimetres and degrees. Which is measured on computer software.	The positional deviations between the attachments on the models and the mouth	Day 0 - Day 2

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Accuracy; Indirect bonding
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 03-05.04.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No