Quantitative Evaluation of the Effect of Dehydration and Rehydration Levels on Tooth Color
Primary Purpose
Tooth Discoloration
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
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
Digital Camera with cross-polarization filter
Digital Camera with cross-polarization filter and gray reference card
Digital Camera with gray reference card
Rayplicker
Rayplicker with gray reference card
Vita Easyshade
Vita Easyshade with gray reference card
Sponsored by
About this trial
This is an interventional other trial for Tooth Discoloration focused on measuring Dehydration, Rehydration, Tooth Color, Dental Photography, Color Measurement
Eligibility Criteria
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
Sites / Locations
- Marmara University Faculty of Dentistry
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Group 1
Arm Description
30 patients will be examined for changes in tooth color.
Outcomes
Primary Outcome Measures
Tooth color measurement
tooth color changes after 15 seconds (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Secondary Outcome Measures
Tooth color measurement
tooth color changes after 1 minute (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05620277
Brief Title
Quantitative Evaluation of the Effect of Dehydration and Rehydration Levels on Tooth Color
Official Title
Quantitative Evaluation of the Effect of Dehydration and Rehydration Levels on Tooth Color Using Various Measurement Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
June 5, 2023 (Anticipated)
Study Completion Date
June 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
Keywords
Dehydration, Rehydration, Tooth Color, Dental Photography, Color Measurement
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
30 patients will be examined for changes in tooth color after dehydration and rehydration stages.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
30 patients will be examined for changes in tooth color.
Intervention Type
Diagnostic Test
Intervention Name(s)
Mobile Dental Photography
Intervention Description
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography
Intervention Type
Diagnostic Test
Intervention Name(s)
Mobile Dental Photography with cross-polarization filter
Intervention Description
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a cross-polarization filter
Intervention Type
Diagnostic Test
Intervention Name(s)
Mobile Dental Photography with gray reference card
Intervention Description
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a gray reference card
Intervention Type
Diagnostic Test
Intervention Name(s)
Mobile Dental Photography with cross-polarization filter and gray reference card
Intervention Description
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a cross-polarization filter and gray reference card
Intervention Type
Diagnostic Test
Intervention Name(s)
Digital Camera
Intervention Description
Tooth color changes of 30 patients will be evaluated using a Digital Camera
Intervention Type
Diagnostic Test
Intervention Name(s)
Digital Camera with cross-polarization filter
Intervention Description
Tooth color changes of 30 patients will be evaluated using a Digital Camera with cross-polarization filter
Intervention Type
Diagnostic Test
Intervention Name(s)
Digital Camera with cross-polarization filter and gray reference card
Intervention Description
Tooth color changes of 30 patients will be evaluated using a Digital Camera with a cross-polarization filter and gray reference card
Intervention Type
Diagnostic Test
Intervention Name(s)
Digital Camera with gray reference card
Intervention Description
Tooth color changes of 30 patients will be evaluated using a Digital Camera with a gray reference card
Intervention Type
Diagnostic Test
Intervention Name(s)
Rayplicker
Intervention Description
Tooth color changes of 30 patients will be evaluated using Rayplicker
Intervention Type
Diagnostic Test
Intervention Name(s)
Rayplicker with gray reference card
Intervention Description
Tooth color changes of 30 patients will be evaluated using Rayplicker with gray reference card
Intervention Type
Diagnostic Test
Intervention Name(s)
Vita Easyshade
Intervention Description
Tooth color changes of 30 patients will be evaluated using Vita Easyshade
Intervention Type
Diagnostic Test
Intervention Name(s)
Vita Easyshade with gray reference card
Intervention Description
Tooth color changes of 30 patients will be evaluated using Vita Easyshade with a gray reference card
Primary Outcome Measure Information:
Title
Tooth color measurement
Description
tooth color changes after 15 seconds (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Time Frame
15 seconds
Secondary Outcome Measure Information:
Title
Tooth color measurement
Description
tooth color changes after 1 minute (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Time Frame
1 minute
Other Pre-specified Outcome Measures:
Title
Tooth color measurement
Description
tooth color changes after 2 minutes (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Time Frame
2 minutes
Title
Tooth color measurement
Description
tooth color changes after 3 minutes (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Time Frame
3 minutes
Title
Tooth color measurement
Description
tooth color changes after 5 minutes (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Time Frame
5 minutes
Title
Tooth color measurement
Description
tooth color changes after 30 minutes (rehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Time Frame
30 minutes
Title
Tooth color measurement
Description
tooth color changes after 60 minutes (rehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Time Frame
60 minutes
Title
Tooth color measurement
Description
tooth color changes after 24 hours (rehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Çiğdem Haciali, DDS
Organizational Affiliation
Marmara University Faculty of Dentistry Department of Restorative Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University Faculty of Dentistry
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Quantitative Evaluation of the Effect of Dehydration and Rehydration Levels on Tooth Color
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