NCT03754283

Brief Summary

The aim of this study is to comparatively investigate the performances of two different and widely used transfer trays during indirect bonding of the orthodontic braces.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

November 19, 2018

Last Update Submit

November 22, 2018

Conditions

Malocclusion

Keywords

Indirect bondingAccuracy

Outcome Measures

Primary Outcomes (1)

  • Transfer accuracy (composite outcome) in milimetres and degrees. Which is measured on computer software.

    The positional deviations between the attachments on the models and the mouth

    Day 0 - Day 2

Study Arms (2)

Silicone

EXPERIMENTAL

Indirect bonding performed with the silicone trays

Device: Indirect bonding

Vacuum formed

ACTIVE COMPARATOR

Indirect bonding performed with the vacuum formed trays

Device: Indirect bonding

Interventions

Indirect bondingDEVICE

Indirect bonding is the technique where orthodontic appliances are first placed on a model of the patient and then transferred to the patient using some kinf of trays

SiliconeVacuum formed

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The presence of indication for both arches to be bonded in the same appointment

You may not qualify if:

  • Presence of restorations, hypoplasia or decalcification on vestibular tooth surfaces
  • Abnormal crown morphology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cihan Aydoğan

Van, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant prof

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 27, 2018

Study Start

June 1, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)