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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Istanbul, Turkey, 34854
        • Marmara University Faculty of Dentistry

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group 1
30 patients will be examined for changes in tooth color.
Diagnostic test: Mobile Dental Photography
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography
Diagnostic test: Mobile Dental Photography with cross-polarization filter
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a cross-polarization filter
Diagnostic test: Mobile Dental Photography with gray reference card
Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography with a gray reference card
Diagnostic test: Mobile Dental Photography with cross-polarization filter and 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
Diagnostic test: Digital Camera
Tooth color changes of 30 patients will be evaluated using a Digital Camera
Diagnostic test: Digital Camera with cross-polarization filter
Tooth color changes of 30 patients will be evaluated using a Digital Camera with cross-polarization filter
Diagnostic test: Digital Camera with cross-polarization filter and gray reference card
Tooth color changes of 30 patients will be evaluated using a Digital Camera with a cross-polarization filter and gray reference card
Diagnostic test: Digital Camera with gray reference card
Tooth color changes of 30 patients will be evaluated using a Digital Camera with a gray reference card
Diagnostic test: Rayplicker
Tooth color changes of 30 patients will be evaluated using Rayplicker
Diagnostic test: Rayplicker with gray reference card
Tooth color changes of 30 patients will be evaluated using Rayplicker with gray reference card
Diagnostic test: Vita Easyshade
Tooth color changes of 30 patients will be evaluated using Vita Easyshade
Diagnostic test: Vita Easyshade with gray reference card
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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