Tooth ColorNCT04105829
Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change
A study testing Bond-a braid, EverStick-Ortho and Ribbond in people with Tooth Color, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Color
- What is being tested?
- Bond-a braid, EverStick-Ortho and Ribbond
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2019to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients with no anomalies of lower incisors and canine teeth
Who cannot join
- patients drinking more then 3 cups of coffee per day
- smoker patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Şehitkamil, 27310
About this study
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
Read the 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.
- Conditions
- Tooth Color
- Being tested
- Bond-a braid, EverStick-Ortho, Ribbond
- Keywords
- tooth color change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bond-a braidOther
Stainless steel lingual retainer application
EverStick-OrthoOther
Fiber reinforced lingual retainer
RibbondOther
Fiber reinforced lingual retainer
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Bond-a braid; Other: EverStick-Ortho; Other: Ribbond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color change
Measurement of tooth color change with spectrophotometry
Measured: before debonding, after debonding on 1st, 3rd, 6th months and 1st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start22 May 2019
- Primary completion10 Aug 2019
- Study completion20 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ColorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Gulec, University of Gaziantep
- Investigators
- Merve Goymen, PhD, Study chair, University of GaziantepDerya Sürmelioğlu, Study chair, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105829
- Sponsor's protocol ID
- 210
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change
- ClinicalTrials.gov ID
- NCT04105829
- Acronym / sponsor ID
- 210
- Conditions
- Tooth Color
- Keywords
- tooth color change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 20 Feb 2020 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tooth color measurement | Experimental | Other: Bond-a braid, Other: EverStick-Ortho, Other: RibbondTooth color changes between times (before retainer bonding, after retainer bonding, in 1 month, 3 months, 6 months and a year) |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients with no anomalies of lower incisors and canine teeth
Key exclusion criteria (2 listed)
- patients drinking more then 3 cups of coffee per day
- smoker patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bond-a braidStainless steel lingual retainer application | Other | Tooth color measurement |
| EverStick-OrthoFiber reinforced lingual retainer | Other | Tooth color measurement |
| RibbondFiber reinforced lingual retainer | Other | Tooth color measurement |
Primary outcome
Tooth color change
Time frame: before debonding, after debonding on 1st, 3rd, 6th months and 1st year
Measurement of tooth color change with spectrophotometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Goymen, PhD study chair
University of Gaziantep
Derya Sürmelioğlu study chair
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bond-a braid, EverStick-Ortho and Ribbond in people with Tooth Color, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth color change (time frame: before debonding, after debonding on 1st, 3rd, 6th months and 1st year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.