Evaluation of Segmented Versus Full Arch Three Dimensionally Printed Transfer Tray for Orthodontic Indirect Bonding

Evaluation of Segmented Versus Full Arch Three Dimensionally Printed Transfer Tray for Orthodontic Indirect Bonding: Randomized Controlled Trial

This study is conducted to overcome the problems of conventional indirect bonding technique, through investigating accuracy of two novel three dimensionally digitally printed indirect bonding transfer trays (full arch & segmented) in terms of accuracy of transferring brackets, rate of immediate bond failure and chair side time.

Study Overview

• Status: Unknown
• Conditions: Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray; Accuracy of Bracket Transfer and Bond Failure Rate of Full Arch and Segmented Digitally Printed Trays
• Intervention / Treatment: Other: Segmented three dimensionally printed transfer tray

Detailed Description

Fourteen patients (7 in each group) with mild to moderate crowding, requiring orthodontic treatment with full set of permanent teeth including second molars, will be selected for this study. A total of 196 brackets will be used (98 Full Arch Tray and 98 Segment Arch Tray). The same bracket type and bonding material will used in both groups. The accuracy of bracket transfer will be measured by 3 Shape Ortho planner software (Bracket Placement Module), rate of bond failure by counting number of debonded brackets upon tray removal & chair side time by using digital watch.

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients seeking fixed orthodontic treatment with full set of permanent teeth including second molars.
2. No sex predilection.
3. Mild to moderate crowding cases (4-6 mm).

Exclusion Criteria:

1. Severely rotated teeth
2. Enamel hypoplasia or hypocalcification.
3. Systemic disease that contraindicates orthodontic treatment.
4. Presence of deep carious lesions or large restorations.
5. No or poor patient's compliance & bad oral hygiene.
6. Psychological problems.

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: Segmented Three dimensionally printed transfer tray	Other: Segmented three dimensionally printed transfer tray; Segmented indirect bonding transfer tray
No Intervention: Full arch three dimensionally printed transfer tray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of 3D printed full arch &segmented transfer tray.	Using Digital Measurements on 3shape 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 number of brackets or tubes failed immediately after bonding	immediate

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): November 30, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2018-04-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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