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Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04105829
Recruitment Status : Active, not recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Information provided by (Responsible Party):
Aysegul Gulec, University of Gaziantep

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

Condition or disease Intervention/treatment Phase
Tooth Color Other: Bond-a braid Other: EverStick-Ortho Other: Ribbond Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change
Actual Study Start Date : May 22, 2019
Actual Primary Completion Date : August 10, 2019
Estimated Study Completion Date : February 20, 2020

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

Primary Outcome Measures :
  1. Tooth color change [ Time Frame: before debonding, after debonding on 1st, 3rd, 6th months and 1st year ]
    Measurement of tooth color change with spectrophotometry

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04105829

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Gaziantep University
Gaziantep, Şehitkamil, Turkey, 27310
Sponsors and Collaborators
University of Gaziantep
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Study Chair: Merve Goymen, PhD University of Gaziantep
Study Chair: Derya Sürmelioğlu University of Gaziantep

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Responsible Party: Aysegul Gulec, Principal investigator, University of Gaziantep Identifier: NCT04105829    
Other Study ID Numbers: 210
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aysegul Gulec, University of Gaziantep:
tooth color change