- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05620277
Quantitative Evaluation of the Effect of Dehydration and Rehydration Levels on Tooth Color
November 16, 2022 updated by: Marmara University
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
- 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
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34854
- Marmara University Faculty of Dentistry
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 36 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy periodontal tissue
- tooth color in A1, A2, or A3
Exclusion Criteria:
- any systemic diseases
- smoking
- restoration or caries in anterior teeth
- vital and devital bleaching application
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Group 1
30 patients will be examined for changes in tooth color.
|
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a cross-polarization filter
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a gray reference card
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a cross-polarization filter and gray reference card
Tooth color changes of 30 patients will be evaluated using a Digital Camera
Tooth color changes of 30 patients will be evaluated using a Digital Camera with cross-polarization filter
Tooth color changes of 30 patients will be evaluated using a Digital Camera with a cross-polarization filter and gray reference card
Tooth color changes of 30 patients will be evaluated using a Digital Camera with a gray reference card
Tooth color changes of 30 patients will be evaluated using Rayplicker
Tooth color changes of 30 patients will be evaluated using Rayplicker with gray reference card
Tooth color changes of 30 patients will be evaluated using Vita Easyshade
Tooth color changes of 30 patients will be evaluated using Vita Easyshade with a gray reference card
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
15 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tooth color measurement
Time Frame: 1 minute
|
tooth color changes after 1 minute (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
|
1 minute
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tooth color measurement
Time Frame: 2 minutes
|
tooth color changes after 2 minutes (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
|
2 minutes
|
|
Tooth color measurement
Time Frame: 3 minutes
|
tooth color changes after 3 minutes (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
|
3 minutes
|
|
Tooth color measurement
Time Frame: 5 minutes
|
tooth color changes after 5 minutes (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
|
5 minutes
|
|
Tooth color measurement
Time Frame: 30 minutes
|
tooth color changes after 30 minutes (rehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
|
30 minutes
|
|
Tooth color measurement
Time Frame: 60 minutes
|
tooth color changes after 60 minutes (rehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
|
60 minutes
|
|
Tooth color measurement
Time Frame: 24 hours
|
tooth color changes after 24 hours (rehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Çiğdem Haciali, DDS, Marmara University Faculty of Dentistry Department of Restorative Dentistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2022
Primary Completion (Anticipated)
June 5, 2023
Study Completion (Anticipated)
June 5, 2024
Study Registration Dates
First Submitted
November 2, 2022
First Submitted That Met QC Criteria
November 16, 2022
First Posted (Actual)
November 17, 2022
Study Record Updates
Last Update Posted (Actual)
November 17, 2022
Last Update Submitted That Met QC Criteria
November 16, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Stomatognathic Diseases
- Tooth Diseases
- Water-Electrolyte Imbalance
- Dehydration
- Tooth Discoloration
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin E
- Tocopherols
- alpha-Tocopherol
Other Study ID Numbers
- 200253bK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Data will be shared after the publication of the article.
IPD Sharing Time Frame
data will be available in 2 years.
IPD Sharing Access Criteria
all researchers may access the data of this study
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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