Tooth DiscolorationNCT05620277
Quantitative Evaluation of the Effect of Dehydration and Rehydration Levels on Tooth Color
A study testing Mobile Dental Photography, Mobile Dental Photography with cross-polarization filter and Mobile Dental Photography with gray reference card in people with Tooth Discoloration, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the dehydration and rehydration changes in teeth over time and the quantitative effect of these changes on natural tooth color in the clinic. In addition, it is aimed to evaluate the effectiveness of different color measuring devices used in color detection in the clinic, the use of… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Mobile Dental Photography, Mobile Dental Photography with cross-polarization filter and Mobile Dental Photography with gray reference card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2022to 5 Jun 2024
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy periodontal tissue
- tooth color in A1, A2, or A3
Who cannot join
- any systemic diseases
- smoking
- restoration or caries in anterior teeth
- vital and devital bleaching application
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, 34854
About this study
Official title: Quantitative Evaluation of the Effect of Dehydration and Rehydration Levels on Tooth Color Using Various Measurement Techniques
This study aims to evaluate the dehydration and rehydration changes in teeth over time and the quantitative effect of these changes on natural tooth color in the clinic. In addition, it is aimed to evaluate the effectiveness of different color measuring devices used in color detection in the clinic, the use of cross-polarization filters, and white balance calibration in color evaluation. Clinicians will evaluate the results of the time intervals in which dehydration is effective in detectable levels of color change. Considering the quantitative changes in dehydrated and rehydrated teeth, it will be possible to prevent negative results in restorations.
Read the detailed description
According to the criteria determined in our study, 30 individuals were repeated with their mouths open for 15 seconds, 1 minute, 2 minutes, 3 minutes, and 5 minutes with a camera, MDP device, and the use of these devices with a cross-polarization filter to determine how dehydration will affect the tooth color. For white balance calibration, all the shots will be taken the same way with the gray reference card, and the color measurements of the teeth will be taken with two different spectrophotometers in the determined parameters. After these measurements, patients will be kept with their mouths closed and tooth color measurements will be taken after 30 minutes and 60 minutes of remineralization. The patients will be called again 24 hours after these procedures the final color measurement will be made and the basic color parameters will be recorded. Spectrophotometric images will be analyzed according to the manufacturer's instructions. The spectrophotometer shall be calibrated and used according to the manufacturer's instructions before each measurement set. In restorative dentistry clinical applications, color selection errors, which are irreversible errors caused by the color changes of the teeth due to dehydration, will be determined in detail in a short time due to dehydration in the teeth, as a result of this clinical study, and with the result of rehydration, the color change levels will be determined in detail. return will be determined. In this way, it is aimed to create a clearer template for physicians based on time in terms of color selection in the clinic. It is aimed to avoid the need for renewal and avoid unnecessary sessions, as color harmony can be achieved in restorations made by considering the color changes of the tooth during dehydration and rehydration periods. Different photographic techniques and colorimeters will also help measure color variations. In addition, the sensitivity of the color detection methods used in our study will be evaluated comparatively, ensuring which method gives more accurate and reproducible results in clinical applications.
- Conditions
- Tooth Discoloration
- Being tested
- Mobile Dental Photography, Mobile Dental Photography with cross-polarization filter, Mobile Dental Photography with gray reference card, Mobile Dental Photography with cross-polarization filter and gray reference card, Digital Camera
- Keywords
- Dehydration, Rehydration, Tooth Color, Dental Photography, Color Measurement
- Medical subject headings
- Tooth Discoloration, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Dental PhotographyDiagnostic test
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography
Mobile Dental Photography with cross-polarization filterDiagnostic test
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a cross-polarization filter
Mobile Dental Photography with gray reference cardDiagnostic test
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a gray reference card
Mobile Dental Photography with cross-polarization filter and gray reference cardDiagnostic test
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a cross-polarization filter and gray reference card
Digital CameraDiagnostic test
Tooth color changes of 30 patients will be evaluated using a Digital Camera
Digital Camera with cross-polarization filterDiagnostic test
Tooth color changes of 30 patients will be evaluated using a Digital Camera with cross-polarization filter
Digital Camera with cross-polarization filter and gray reference cardDiagnostic test
Tooth color changes of 30 patients will be evaluated using a Digital Camera with a cross-polarization filter and gray reference card
Digital Camera with gray reference cardDiagnostic test
Tooth color changes of 30 patients will be evaluated using a Digital Camera with a gray reference card
RayplickerDiagnostic test
Tooth color changes of 30 patients will be evaluated using Rayplicker
Rayplicker with gray reference cardDiagnostic test
Tooth color changes of 30 patients will be evaluated using Rayplicker with gray reference card
Vita EasyshadeDiagnostic test
Tooth color changes of 30 patients will be evaluated using Vita Easyshade
Vita Easyshade with gray reference cardDiagnostic test
Tooth color changes of 30 patients will be evaluated using Vita Easyshade with a gray reference card
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | 30 patients will be examined for changes in tooth color. Receives: Diagnostic Test: Mobile Dental Photography; Diagnostic Test: Mobile Dental Photography with cross-polarization filter; Diagnostic Test: Mobile Dental Photography with gray reference card; Diagnostic Test: Mobile Dental Photography with cross-polarization filter and gray reference card; Diagnostic Test: Digital Camera; Diagnostic Test: Digital Camera with cross-polarization filter; Diagnostic Test: Digital Camera with cross-polarization filter and gray reference card; Diagnostic Test: Digital Camera with gray reference card; Diagnostic Test: Rayplicker; Diagnostic Test: Rayplicker with gray reference card; Diagnostic Test: Vita Easyshade; Diagnostic Test: Vita Easyshade with gray reference card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color measurement
tooth color changes after 15 seconds (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Measured: 15 seconds
Secondary outcomes (1)
Tooth color measurement
tooth color changes after 1 minute (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start5 Jun 2022
- Primary completion5 Jun 2023 (estimated)
- Study completion5 Jun 2024 (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 Marmara 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 30 patients will be examined for changes in tooth color after dehydration and rehydration stages.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Çiğdem Haciali, DDS, Principal investigator, Marmara University Faculty of Dentistry Department of Restorative Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620277
- Sponsor's protocol ID
- 200253bK
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after the publication of the article.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Evaluation of the Effect of Dehydration and Rehydration Levels on Tooth Color Using Various Measurement Techniques
- ClinicalTrials.gov ID
- NCT05620277
- Acronym / sponsor ID
- 200253bK
- Conditions
- Tooth Discoloration
- Keywords
- Dehydration, Rehydration, Tooth Color, Dental Photography, Color Measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 5 Jun 2023 (estimated)
- Study completion
- 5 Jun 2024 (estimated)
- First posted
- 17 Nov 2022 (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 aims to evaluate the dehydration and rehydration changes in teeth over time and the quantitative effect of these changes on natural tooth color in the clinic. In addition, it is aimed to evaluate the effectiveness of different color measuring devices used in color detection in the clinic, the use of cross-polarization filters, and white balance calibration in color evaluation. Clinicians will evaluate the results of the time intervals in which dehydration is effective in detectable levels of color change. Considering the quantitative changes in dehydrated and rehydrated teeth, it will be possible to prevent negative results in restorations.
Detailed description
According to the criteria determined in our study, 30 individuals were repeated with their mouths open for 15 seconds, 1 minute, 2 minutes, 3 minutes, and 5 minutes with a camera, MDP device, and the use of these devices with a cross-polarization filter to determine how dehydration will affect the tooth color. For white balance calibration, all the shots will be taken the same way with the gray reference card, and the color measurements of the teeth will be taken with two different spectrophotometers in the determined parameters. After these measurements, patients will be kept with their mouths closed and tooth color measurements will be taken after 30 minutes and 60 minutes of remineralization. The patients will be called again 24 hours after these procedures the final color measurement will be made and the basic color parameters will be recorded. Spectrophotometric images will be analyzed according to the manufacturer's instructions. The spectrophotometer shall be calibrated and used according to the manufacturer's instructions before each measurement set. In restorative dentistry clinical applications, color selection errors, which are irreversible errors caused by the color changes of the teeth due to dehydration, will be determined in detail in a short time due to dehydration in the teeth, as a result of this clinical study, and with the result of rehydration, the color change levels will be determined in detail. return will be determined. In this way, it is aimed to create a clearer template for physicians based on time in terms of color selection in the clinic. It is aimed to avoid the need for renewal and avoid unnecessary sessions, as color harmony can be achieved in restorations made by considering the color changes of the tooth during dehydration and rehydration periods. Different photographic techniques and colorimeters will also help measure color variations. In addition, the sensitivity of the color detection methods used in our study will be evaluated comparatively, ensuring which method gives more accurate and reproducible results in clinical applications.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 30 patients will be examined for changes in tooth color after dehydration and rehydration stages.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Diagnostic Test: Mobile Dental Photography, Diagnostic Test: Mobile Dental Photography with cross-polarization filter, Diagnostic Test: Mobile Dental Photography with gray reference card, Diagnostic Test: Mobile Dental Photography with cross-polarization filter and gray reference card, Diagnostic Test: Digital Camera, Diagnostic Test: Digital Camera with cross-polarization filter, Diagnostic Test: Digital Camera with cross-polarization filter and gray reference card, Diagnostic Test: Digital Camera with gray reference card, Diagnostic Test: Rayplicker, Diagnostic Test: Rayplicker with gray reference card, Diagnostic Test: Vita Easyshade, Diagnostic Test: Vita Easyshade with gray reference card30 patients will be examined for changes in tooth color. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy periodontal tissue
- tooth color in A1, A2, or A3
Key exclusion criteria (4 listed)
- any systemic diseases
- smoking
- restoration or caries in anterior teeth
- vital and devital bleaching application
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 |
|---|---|---|
| Mobile Dental PhotographyTooth color changes of 30 patients will be evaluated using Mobile Dental Photography | Diagnostic test | Group 1 |
| Mobile Dental Photography with cross-polarization filterTooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a cross-polarization filter | Diagnostic test | Group 1 |
| Mobile Dental Photography with gray reference cardTooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a gray reference card | Diagnostic test | Group 1 |
| Mobile Dental Photography with cross-polarization filter and gray reference cardTooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a cross-polarization filter and gray reference card | Diagnostic test | Group 1 |
| Digital CameraTooth color changes of 30 patients will be evaluated using a Digital Camera | Diagnostic test | Group 1 |
| Digital Camera with cross-polarization filterTooth color changes of 30 patients will be evaluated using a Digital Camera with cross-polarization filter | Diagnostic test | Group 1 |
| Digital Camera with cross-polarization filter and gray reference cardTooth color changes of 30 patients will be evaluated using a Digital Camera with a cross-polarization filter and gray reference card | Diagnostic test | Group 1 |
| Digital Camera with gray reference cardTooth color changes of 30 patients will be evaluated using a Digital Camera with a gray reference card | Diagnostic test | Group 1 |
| RayplickerTooth color changes of 30 patients will be evaluated using Rayplicker | Diagnostic test | Group 1 |
| Rayplicker with gray reference cardTooth color changes of 30 patients will be evaluated using Rayplicker with gray reference card | Diagnostic test | Group 1 |
| Vita EasyshadeTooth color changes of 30 patients will be evaluated using Vita Easyshade | Diagnostic test | Group 1 |
| Vita Easyshade with gray reference cardTooth color changes of 30 patients will be evaluated using Vita Easyshade with a gray reference card | Diagnostic test | Group 1 |
Primary outcome
Tooth color measurement
Time frame: 15 seconds
tooth color changes after 15 seconds (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
1 secondary outcome
Tooth color measurement
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: Yes. Data will be shared after the publication of the article.
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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.
Çiğdem Haciali, DDS principal investigator
Marmara University Faculty of Dentistry Department of Restorative Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Dental Photography, Mobile Dental Photography with cross-polarization filter and Mobile Dental Photography with gray reference card in people with Tooth Discoloration, run by Marmara 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 2 inclusion and 4 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 17 Nov 2022. 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 measurement (time frame: 15 seconds). 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 17 Nov 2022.