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NCT03754283 Clinical Trial

Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays

Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03754283
Other study ID # 03-05.04.2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date September 1, 2017

Study information
Verified date November 2018
Source Yuzuncu Yil University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 15 Years to 20 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Cihan Aydogan Van

Sponsors (1)
Lead Sponsor Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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