NCT03363607

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

December 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

November 26, 2017

Last Update Submit

November 30, 2017

Conditions

Orthodontic Indirect Bonding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Bonding failure of the brackets.

    three months

  • Chair side time

    during the bonding procedure

Study Arms (2)

3D printed transfer tray group

EXPERIMENTAL

Indirect bonding using digital 3D printed transfer tray

Procedure: Digital indirect bondingProcedure: Intraoral scanningProcedure: Superimposition and evaluation

Thermoformed transfer tray group

ACTIVE COMPARATOR

Indirect bonding using Thermoformed transfer tray

Procedure: Conventional indirect bondingProcedure: Intraoral scanningProcedure: Superimposition and evaluation

Interventions

Digital indirect bondingPROCEDURE

Indirect bonding of orthodontic attachments using digital 3D printed transfer tray

3D printed transfer tray group
Conventional indirect bondingPROCEDURE

Indirect bonding of orthodontic attachments using thermoformed transfer tray

Thermoformed transfer tray group
Intraoral scanningPROCEDURE

Intraoral Scanning of the bonded brackets

3D printed transfer tray groupThermoformed transfer tray group
Superimposition and evaluationPROCEDURE

superimposition of the brackets' positions before and after bonding and evaluation of the transfer accuracy

3D printed transfer tray groupThermoformed transfer tray group

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident , MS candidate

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 6, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

December 6, 2017

Record last verified: 2017-11