Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change

September 25, 2019 updated by: Aysegul Gulec, University of Gaziantep
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

30 patients who were planned to use lower fixed retainer after fixed orthodontic treatment, were included in the study and divided into 3 groups. (n=10) (Group 1: Bond a braid retainer, Group 2: Ribbond retainer, Group 3: EverStick Ortho retainer). Colour measurements will be made with spectrophotometer (Vita easyshade) after debonding (T1), after retainer application (T2), in 1 month, 3 month, 6 month and finally 1 year from 6 lower anterior teeth. The Commission Internationale de I'Echairage L*a*b* system will be used to determine the tooth colour. ∆E values measured at different times will be compared.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Şehitkamil
      • Gaziantep, Şehitkamil, Turkey, 27310
        • Gaziantep University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with no anomalies of lower incisors and canine teeth

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tooth color measurement
Tooth color changes between times (before retainer bonding, after retainer bonding, in 1 month, 3 months, 6 months and a year)
Other: Bond-a braid
Stainless steel lingual retainer application
Other: EverStick-Ortho
Fiber reinforced lingual retainer
Other: Ribbond
Fiber reinforced lingual retainer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth color change
Time Frame: before debonding, after debonding on 1st, 3rd, 6th months and 1st year
Measurement of tooth color change with spectrophotometry
before debonding, after debonding on 1st, 3rd, 6th months and 1st year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Gaziantep

Investigators

  • Study Chair: Merve Goymen, PhD, University of Gaziantep
  • Study Chair: Derya Sürmelioğlu, University of Gaziantep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 22, 2019

Primary Completion (ACTUAL)

August 10, 2019

Study Completion (ANTICIPATED)

February 20, 2020

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (ACTUAL)

September 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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