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

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ClinicalTrials.gov Identifier: NCT03363607
Recruitment Status : Unknown
Verified November 2017 by Omar Abdelaziz, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Omar Abdelaziz, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Orthodontic Indirect Bonding Procedure: Digital indirect bonding Procedure: Conventional indirect bonding Procedure: Intraoral scanning Procedure: Superimposition and evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding: A Randomized Clinical Trial
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

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: Conventional indirect bonding
Indirect bonding of orthodontic attachments 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




Primary Outcome Measures :
  1. Linear and angular Positioning of the brackets [ Time Frame: Immediately after bonding ]
    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.


Secondary Outcome Measures :
  1. Bonding failure of the brackets. [ Time Frame: three months ]
    Evaluation of the bond failure by counting the number of detached brackets immediately and over a three months follow up period.

  2. Chair side time [ Time Frame: during the bonding procedure ]
    To evaluate the chair side time of indirect bonding in each technique



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: Omar Abdelaziz, Resident , MS candidate, Cairo University
ClinicalTrials.gov Identifier: NCT03363607    
Other Study ID Numbers: CEBC-CU-2017-11-28
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No