Tooth DiscolorationColorNCT06791694
Comparison of Color Measurements of Postgraduate Dental Students Using Different Color Determination Methods
An observational study of Tooth Discoloration, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the accuracy of tooth color identification skills in the anterior region using a new technique, the button technique, in comparison with other methods. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Resins, Composite
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2025to 1 Mar 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Being healthy individuals, not having any systemic diseases, being young individuals (18-40 age range)
Who may be able to join
- Being healthy individuals,
- Not having any systemic diseases,
- Being young individuals (18-40 age range)
- Vital, decay-free and healthy upper central teeth,
- Absence of caries-free hard tissue abrasions, any restoration, fracture, crack, intrinsic or extrinsic discoloration in the upper central teeth
- Lack of removable prosthesis feet for central teeth
Who cannot join
- Tetracycline, fluorosis staining of upper central teeth
- Patients with dentin exposure or loss of bine in the upper central teeth for any reason
- Pregnant and lactating patients will not be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Color Measurements of Postgraduate Dental Students in the Maxillary Anterior Region Using Different Color Determination Methods
This study evaluates the accuracy of tooth color identification skills in the anterior region using a new technique, the button technique, in comparison with other methods.
Read the detailed description
The human eye is effective in detecting subtle differences in tooth color. However, variations in the shade, translucency, opacity, and characterization of a tooth may not be accurately identified. Visual color matching is subject to physiological variables that may lead to inconsistencies, such as age, gender, experience, the type of scale used, varying degrees of light exposure, eye fatigue, and color vision deficiency.
Studies comparing visual and instrumental methods have demonstrated that spectrophotometers yield better results compared to visual color scales. Therefore, it is expected that color measurement devices improve the accuracy of tooth color determination, thereby enhancing the interpretation and aesthetic execution of restorations.
In recent years, the button technique has been described for shade selection in direct aesthetic restorations in the anterior region. In this technique, small composite samples in the form of dots are polymerized on the tooth surface using a curing light. Digital photographs are then taken, and appropriate enamel and dentin shades are selected on a computer using polarized and black-and-white images.
Very few clinical studies have investigated the use of digital color images obtained through intraoral digital scanners for shade selection, comparing them with other existing methods.
The aim of this study is to evaluate the accuracy of shade determination skills in the anterior region by comparing a new technique, the button technique, with other methods and to recommend the most suitable method for shade selection
- Conditions
- Tooth Discoloration
- Being tested
- Resins, Composite
- Keywords
- color, tooth, button
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resins, CompositeOther
Also called vita classical, Vita 3D master, spectrophotometer
Graduate students; healthy maxillary central teeth and color measurements will be performed with 4 different methods in at least 32 patients aged between 18-40 years. Firstly, students will be asked to make color measurements using the traditional method with two different color scales (Vita classical and Vita 3D master). As the third method; the enamel color of the teeth will be determined on digital photographs using the buton technique. Finally, tooth color will be measured on the buccal surface of the central teeth using a spectrophotometer.
What is being measured
The primary outcome is the main question the study is designed to answer.
To have compared the inter-observer reliability of 4 different methods used in tooth color selection
To have compared the inter-observer reliability of 4 different methods used in tooth color selection
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start27 Jan 2025
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal Işıklı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791694
- Sponsor's protocol ID
- KA-21049
- Acronym
- Color
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Color Measurements of Postgraduate Dental Students in the Maxillary Anterior Region Using Different Color Determination Methods
- ClinicalTrials.gov ID
- NCT06791694
- Acronym / sponsor ID
- Color / KA-21049
- Conditions
- Tooth Discoloration
- Keywords
- color, tooth, button
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 24 Jan 2025 (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.
This study evaluates the accuracy of tooth color identification skills in the anterior region using a new technique, the button technique, in comparison with other methods.
Detailed description
The human eye is effective in detecting subtle differences in tooth color. However, variations in the shade, translucency, opacity, and characterization of a tooth may not be accurately identified. Visual color matching is subject to physiological variables that may lead to inconsistencies, such as age, gender, experience, the type of scale used, varying degrees of light exposure, eye fatigue, and color vision deficiency.
Studies comparing visual and instrumental methods have demonstrated that spectrophotometers yield better results compared to visual color scales. Therefore, it is expected that color measurement devices improve the accuracy of tooth color determination, thereby enhancing the interpretation and aesthetic execution of restorations.
In recent years, the button technique has been described for shade selection in direct aesthetic restorations in the anterior region. In this technique, small composite samples in the form of dots are polymerized on the tooth surface using a curing light. Digital photographs are then taken, and appropriate enamel and dentin shades are selected on a computer using polarized and black-and-white images.
Very few clinical studies have investigated the use of digital color images obtained through intraoral digital scanners for shade selection, comparing them with other existing methods.
The aim of this study is to evaluate the accuracy of shade determination skills in the anterior region by comparing a new technique, the button technique, with other methods and to recommend the most suitable method for shade selection
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Being healthy individuals, not having any systemic diseases, being young individuals (18-40 age range)
Key inclusion criteria (6 listed)
- Being healthy individuals,
- Not having any systemic diseases,
- Being young individuals (18-40 age range)
- Vital, decay-free and healthy upper central teeth,
- Absence of caries-free hard tissue abrasions, any restoration, fracture, crack, intrinsic or extrinsic discoloration in the upper central teeth
Key exclusion criteria (3 listed)
- Tetracycline, fluorosis staining of upper central teeth
- Patients with dentin exposure or loss of bine in the upper central teeth for any reason
- Pregnant and lactating patients will not be included.
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 |
|---|---|---|
| Resins, CompositeAlso: vita classical, Vita 3D master, spectrophotometerGraduate students; healthy maxillary central teeth and color measurements will be performed with 4 different methods in at least 32 patients aged between 18-40 years. Firstly, students will be asked to make color measurements using the traditional method with two different color scales (Vita classical and Vita 3D master). As the third method; the enamel color of the teeth will be determined on digital photographs using the buton technique. Finally, tooth color will be measured on the buccal surface of the central teeth using a spectrophotometer. | Other | – |
Primary outcome
To have compared the inter-observer reliability of 4 different methods used in tooth color selection
Time frame: 1 month
To have compared the inter-observer reliability of 4 different methods used in tooth color selection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Discoloration, run by Hacettepe University 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 6 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 30 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
To have compared the inter-observer reliability of 4 different methods used in tooth color selection (time frame: 1 month). 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 30 Jan 2025.