Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding

Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding: A Randomized Clinical Trial

The study evaluates the accuracy of indirect bonding using 3D printed transfer tray versus thermoformed transfer tray. Half of the brackets will be bonded indirectly using the 3D printed transfer tray and the other half will be bonded indirectly using the thermoformed transfer tray.

Study Overview

• Status: Unknown
• Conditions: Orthodontic Indirect Bonding
• Intervention / Treatment: Procedure: Digital indirect bonding; Procedure: Intraoral scanning; Procedure: Superimposition and evaluation; Procedure: Conventional indirect bonding

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients seeking orthodontic treatment with fixed orthodontic appliance.
• Patients with full set of permanent teeth
• Good oral hygiene and periodontal condition.

Exclusion Criteria:

• Patients suffering from any periodontal disease.
• Patients with poor oral hygiene
• Enamel hypoplasia and hypocalcification
• Deep carious lesions / large restorations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3D printed transfer tray group; Indirect bonding using digital 3D printed transfer tray	Procedure: Digital indirect bonding; Indirect bonding of orthodontic attachments using digital 3D printed transfer tray; Procedure: Intraoral scanning; Intraoral Scanning of the bonded brackets; Procedure: Superimposition and evaluation; superimposition of the brackets' positions before and after bonding and evaluation of the transfer accuracy
ACTIVE_COMPARATOR: Thermoformed transfer tray group; Indirect bonding using Thermoformed transfer tray	Procedure: Intraoral scanning; Intraoral Scanning of the bonded brackets; Procedure: Superimposition and evaluation; superimposition of the brackets' positions before and after bonding and evaluation of the transfer accuracy; Procedure: Conventional indirect bonding; Indirect bonding of orthodontic attachments using thermoformed transfer tray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear and angular Positioning of the brackets	To evaluate the transfer accuracy of the brackets by the two transfer trays by measuring the linear and angular differences in the brackets' positions before and after bonding.	Immediately after bonding

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bonding failure of the brackets.	Evaluation of the bond failure by counting the number of detached brackets immediately and over a three months follow up period.	three months
Chair side time	To evaluate the chair side time of indirect bonding in each technique	during the bonding procedure

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: November 26, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (ACTUAL): December 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CEBC-CU-2017-11-28

Drug and device information, study documents

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