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Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays

Primary Purpose

Malocclusion

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Indirect bonding

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Indirect bonding, Accuracy

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cihan Aydoğan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Silicone

Vacuum formed

Arm Description

Indirect bonding performed with the silicone trays

Indirect bonding performed with the vacuum formed trays

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03754283

First Posted

November 19, 2018

Last Updated

November 22, 2018

Sponsor

Yuzuncu Yıl University

1. Study Identification

Unique Protocol Identification Number

NCT03754283

Brief Title

Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

September 1, 2017 (Actual)

Study Completion Date

September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malocclusion

Keywords

Indirect bonding, Accuracy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

1:1

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Silicone

Arm Type

Experimental

Arm Description

Indirect bonding performed with the silicone trays

Arm Title

Vacuum formed

Arm Type

Active Comparator

Arm Description

Indirect bonding performed with the vacuum formed trays

Intervention Type

Device

Intervention Name(s)

Indirect bonding

Intervention Description

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

Primary Outcome Measure Information:

Title

Transfer accuracy (composite outcome) in milimetres and degrees. Which is measured on computer software.

Description

The positional deviations between the attachments on the models and the mouth

Time Frame

Day 0 - Day 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Cihan Aydoğan

City

Van

ZIP/Postal Code

65080

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays

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