NCT04105829

Brief Summary

The aim of this study is to compare the tooth colour changes caused by retainers made of stainless steel wires and fiber reinforced in long term

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 22, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

September 19, 2019

Last Update Submit

September 25, 2019

Conditions

Tooth Color

Keywords

tooth color change

Outcome Measures

Primary Outcomes (1)

  • Tooth color change

    Measurement of tooth color change with spectrophotometry

    before debonding, after debonding on 1st, 3rd, 6th months and 1st year

Study Arms (1)

Tooth color measurement

EXPERIMENTAL

Tooth color changes between times (before retainer bonding, after retainer bonding, in 1 month, 3 months, 6 months and a year)

Other: Bond-a braidOther: EverStick-OrthoOther: Ribbond

Interventions

Bond-a braidOTHER

Stainless steel lingual retainer application

Tooth color measurement
EverStick-OrthoOTHER

Fiber reinforced lingual retainer

Tooth color measurement
RibbondOTHER

Fiber reinforced lingual retainer

Tooth color measurement

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with no anomalies of lower incisors and canine teeth

You may not qualify if:

  • patients drinking more then 3 cups of coffee per day
  • smoker patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

Location

MeSH Terms

Interventions

RIBBOND

Study Officials

  • Merve Goymen, PhD

    University of Gaziantep

    STUDY CHAIR

  • Derya Sürmelioğlu

    University of Gaziantep

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 26, 2019

Study Start

May 22, 2019

Primary Completion

August 10, 2019

Study Completion

February 20, 2020

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)