NCT05620277

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 2, 2022

Last Update Submit

November 16, 2022

Conditions

Tooth Discoloration

Keywords

DehydrationRehydrationTooth ColorDental PhotographyColor Measurement

Outcome Measures

Primary Outcomes (1)

  • Tooth color measurement

    tooth color changes after 15 seconds (dehydration) will be evaluated using Mobile Dental Photography, Digital Camera, Vita Easyshade and Rayplicker

    15 seconds

Secondary Outcomes (1)

  • Tooth color measurement

    1 minute

Other Outcomes (6)

  • Tooth color measurement

    2 minutes

  • Tooth color measurement

    3 minutes

  • Tooth color measurement

    5 minutes

  • +3 more other outcomes

Study Arms (1)

Group 1

OTHER

30 patients will be examined for changes in tooth color.

Diagnostic Test: Mobile Dental PhotographyDiagnostic Test: Mobile Dental Photography with cross-polarization filterDiagnostic Test: Mobile Dental Photography with gray reference cardDiagnostic Test: Mobile Dental Photography with cross-polarization filter and gray reference cardDiagnostic Test: Digital CameraDiagnostic Test: Digital Camera with cross-polarization filterDiagnostic Test: Digital Camera with cross-polarization filter and gray reference cardDiagnostic Test: Digital Camera with gray reference cardDiagnostic Test: RayplickerDiagnostic Test: Rayplicker with gray reference cardDiagnostic Test: Vita EasyshadeDiagnostic Test: Vita Easyshade with gray reference card

Interventions

Mobile Dental PhotographyDIAGNOSTIC_TEST

Tooth color changes of 30 patients will be evaluated using Mobile Dental Photography

Group 1
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

Group 1
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

Group 1
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

Group 1
Digital CameraDIAGNOSTIC_TEST

Tooth color changes of 30 patients will be evaluated using a Digital Camera

Group 1
Digital Camera with cross-polarization filterDIAGNOSTIC_TEST

Tooth color changes of 30 patients will be evaluated using a Digital Camera with cross-polarization filter

Group 1
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

Group 1
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

Group 1
RayplickerDIAGNOSTIC_TEST

Tooth color changes of 30 patients will be evaluated using Rayplicker

Group 1
Rayplicker with gray reference cardDIAGNOSTIC_TEST

Tooth color changes of 30 patients will be evaluated using Rayplicker with gray reference card

Group 1
Vita EasyshadeDIAGNOSTIC_TEST

Tooth color changes of 30 patients will be evaluated using Vita Easyshade

Group 1
Vita Easyshade with gray reference cardDIAGNOSTIC_TEST

Tooth color changes of 30 patients will be evaluated using Vita Easyshade with a gray reference card

Group 1

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy periodontal tissue
  • tooth color in A1, A2, or A3

You may not qualify if:

  • any systemic diseases
  • smoking
  • restoration or caries in anterior teeth
  • vital and devital bleaching application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth DiscolorationDehydration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Çiğdem Haciali, DDS

    Marmara University Faculty of Dentistry Department of Restorative Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 30 patients will be examined for changes in tooth color after dehydration and rehydration stages.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 17, 2022

Study Start

June 5, 2022

Primary Completion

June 5, 2023

Study Completion

June 5, 2024

Last Updated

November 17, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Data will be shared after the publication of the article.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
data will be available in 2 years.
Access Criteria
all researchers may access the data of this study

Locations

TU(1)