Accuracy of 3DPrinted Windowed Bracket- Positioning Guide Compared To Thermoformed Indirect Bonding Tray

Evaluation of Accuracy of 3DPrinted Windowed Bracket- Positioning Guide Compared To Thermoformed Transfer Tray For Orthodontic Indirect Bonding A Randomized Controlled Trial

this study was aimed to evaluate of accuracy of 3DPrinted windowed Bracket- Positioning Guide in compare to Thermoformed Transfer Tray For Orthodontic Indirect Bonding

Study Overview

• Status: Unknown
• Conditions: Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray; Accuracy of Bracket Transfer and Bond Failure Rate of Digitally Printed Transfer Tray With Windows and Conventional Thermoformed Transfer Tray
• Intervention / Treatment: Device: 3DPrinted Windowed Bracket- Positioning tray

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: above 13 years.
2. Complete set of permanent teeth including second molar.
3. No sex predilection.
4. Class I Mild to moderate crowding (4-6 mm).

Exclusion Criteria:

1. Surface enamel defect that compromise bonding
2. No or poor patient's compliance.
3. Psychological problems.
4. Pathology at the site of intervention.
5. Insufficient crown height that contradicts bonding of brackets.
6. Labial and buccal Restorations.
7. Poor oral hygiene.
8. Severely rotated teeth

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: window bracket positioning tray	Device: 3DPrinted Windowed Bracket- Positioning tray; 3 D printed tray with windows for accurate positioning of brackets
No Intervention: conventional indirect boning tray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of 3D printed transfer tray with windows& conventional thermoformed transfer tray	using digital measurements on 3 shape software in mm degrees	immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chairside time	digital stopwatch in seconds	immediate
immediate bond failure	counting after bonding number of brackets or tubes failed immediately	immediate

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: July 1, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 1, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2018-04-18

Drug and device information, study documents

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