Chairside Time and Accuracy of Indirect Bonding of Orthodontic Attachments Using Double Versus Single Transfer Tray

Chairside Time and Accuracy of Indirect Bonding of Orthodontic Attachments Using Double Versus Single Transfer Tray: A Randomized Controlled Trial

compare the chairside time and the accuracy of transferring attachments between single and double sheets vacuum tray techniques during indirect bonding of orthodontic attachments using superimposition on computer software

Study Overview

• Status: Unknown
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Device: single transfer tray; Device: double transfer trays

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient with maxillary full set of teeth and undergoing fixed orthodontic treatment.
2. Good oral hygiene.
3. Mild to moderate crowding.

Exclusion Criteria:

1. Patients with partially erupted teeth in the maxillary arch.
2. Signs of caries, large restorations or abnormalities of crown morphology.
3. The need of banding.
4. Bad oral hygiene measures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: single transfer tray	Device: single transfer tray; single soft tray
Experimental: double transfer trays	Device: double transfer trays; double trays one soft and one hard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chairside time of brackets bonding	using Stop watch	an average of 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of orthodontic attachments transfer	linear (mm) scale using geomagic software	one day after bonding
Accuracy of orthodontic attachments transfer	angular (degrees) scale using geomagic software	one day after bonding

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
immediate Bond failure	number of debonded attachments using hand instrument pressure	immediately after bonding

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: December 2, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CEBC-CU-2017-11-14

Drug and device information, study documents

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