NCT03187483

Brief Summary

This study aimed to compare flash-free bracket system with conventional adhesive-coated bracket system in patients with maxillary crowding.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

June 10, 2017

Last Update Submit

June 12, 2017

Conditions

Orthodontic Treatment

Outcome Measures

Primary Outcomes (1)

  • development of white spot lesion (WSL)

    WSL is the first sign of caries

    1 month

Secondary Outcomes (2)

  • plaque accumulation around the brackets

    1 month

  • microbial composition around the brackets

    1 month

Study Arms (2)

Flash-free bracket group

ACTIVE COMPARATOR

Orthodontic treatment with flash-free bracket system

Procedure: orthodontic treatment

Control

ACTIVE COMPARATOR

Orthodontic treatment with conventional adhesive-coated brackets

Procedure: orthodontic treatment

Interventions

orthodontic treatmentPROCEDURE

orthodontic treatment in maxillary crowding

ControlFlash-free bracket group

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • being systemically healthy
  • having 4-7 mm maxillary crowding with a maximum of 2 mm linear displacement of contact points and non-extraction treatment planning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Orthodontics

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2017

First Posted

June 15, 2017

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

June 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share