Effects of the Different Orthodontic Fixed Retainers on E... | NCT04105829

Studies
Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change

NCT04105829

Sponsor

University of Gaziantep

Status

Unknown status

Last Update Posted

Sep 26, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Tooth Color

Interventions

Bond-a braid
EverStick-Ortho
Ribbond

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2019Actual

Primary Completion Date

Aug 10, 2019Actual

Completion Date

Feb 20, 2020Estimated

First Submitted Date

Sep 19, 2019

First Submission Date that Met QC Criteria

Sep 25, 2019

First Posted Date

Sep 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2019

Last Update Posted Date

Sep 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 braid Other: EverStick-Ortho Other: Ribbond

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bond-a braid	Other	Stainless steel lingual retainer application	Tooth color measurement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merve Goymen, PhD	University of Gaziantep	Study Chair
Derya Sürmelioğlu	University of Gaziantep	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziantep University		Gaziantep	Şehitkamil	27310	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C084063	RIBBOND

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided