NCT03365232

Brief Summary

compare the chair side time, clinical orthodontic attachment bond failure and accuracy of transfer between non custom attachment base and custom attachment base indirect techniques.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

November 25, 2017

Last Update Submit

December 2, 2017

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

  • chair side time

    using stopwatch

    an average of 30 minutes

Secondary Outcomes (1)

  • immediate bond failure

    immediately after bonding

Other Outcomes (2)

  • accuracy of orthodontic attachments transfer

    one day after bonding

  • accuracy of orthodontic attachments transfer

    one day after bonding

Study Arms (2)

non custom base attachment

EXPERIMENTAL
Device: non custom base attachment

custom base attachment

ACTIVE COMPARATOR
Device: custom base attachment

Interventions

non custom base attachmentDEVICE

non custom base attachment

non custom base attachment
custom base attachmentDEVICE

custom base attachment

custom base attachment

Eligibility Criteria

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

You may qualify if:

  • \- Patients should have
  • Maxillary sound teeth and undergoing fixed orthodontic treatment.
  • Space problems ranging from spacing to mild crowding.
  • Good oral hygiene.

You may not qualify if:

  • Patients with partially erupted teeth in the maxillary arch .
  • Signs of caries, large restorations fluorosis, hypoplasia or abnormalities of crown morphology.
  • The need of banding.
  • Bad oral hygiene measures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2017

First Posted

December 7, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

December 7, 2017

Record last verified: 2017-12