- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07295977
Effect of Dehydration on Dental Fluorescence
The Effect of Dehydration on Natural Dental Fluorescence: A Clinical Evaluation
Study Overview
Status
Detailed Description
According to the power analysis, the required number of teeth was 69, with 95% statistical power and a 5% alpha error level. The study will be conducted at the Clinic of the Department of Restorative Dentistry, Marmara University Faculty of Dentistry. Individuals with caries-free teeth, no enamel defects, no restorations on tooth surfaces, no visible plaque, and adequate cognitive ability to read and understand the informed consent form will be included in the study. Those with teeth exhibiting discoloration or with systemic conditions or medication use that may cause structural changes on the tooth surfaces will be excluded. Maxillary and mandibular anterior teeth will be evaluated.
A cheek retractor will be placed in the patients' mouths, and baseline, 5th-minute, and 10th-minute dehydration will be evaluated using three different techniques. Digital photographs will be taken at baseline and post-procedure under two different fluorescence light sources (Ashur plaque indicator (405 nm), and Led lights (365 nm)), and the images obtained using the QLF (Quantitative Light-Induced Fluorescence- 405 nm) device will be recorded. Analyses will be carried out digitally. Images will be captured with a Sony Alpha 7iii (Sony, Japan) digital camera equipped with a 90-mm macro lens. Camera settings will be adjusted for the LED lights (1/125, f/22, ISO 8000) and for the Ashur device (1/125, f/22, ISO 25600). To ensure standardization, the LED lights will be stabilized on the flash brackets at a 45° angle on both sides, and all images will be captured in a dark room. QLF images will be obtained with its own camera. The photographs and the QLF images will be analyzed using Adobe Photoshop software, and color changes will be determined based on ∆E values. For each method ∆E values will be calculated individually, there will be 3 different ∆E values (baseline and 5th-minute, baseline and 10th-minute, 5th-minute and 10th-minute). For ∆E calculations, the CIEDE2000 formula will be used, employing the measured L*, a*, b* and L*, c*, h* values obtained from baseline, 5th-minute and 10th-minute images. For the digital measurements, the intraobserver variability will be assessed, and after obtaining a high level of agreement, the study will be initiated. In statistical analyses, normality will be assessed using the Shapiro-Wilk test; repeated-measures ANOVA will be used if normal distribution is present, and the Friedman test will be applied if normality is not observed. A significance level of p<0.05 will be accepted.
The aim of this clinical study is to clinically evaluate the changes in the fluorescence properties of natural teeth following dehydration.
The hypotheses of the study (H1) are as follows:
- The change in the fluorescence properties of natural teeth after dehydration exceeds clinically acceptable thresholds.
- There is a significant difference among the various fluorescence evaluation methods used in clinical practice.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Marmara University Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals with caries-free teeth, no enamel defects, no restorations on tooth surfaces, no visible plaque, and adequate cognitive ability to read and understand the informed consent form.
Exclusion Criteria:
- Individuals with teeth exhibiting discoloration or with systemic conditions or medication use that may cause structural changes on the tooth surfaces.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group 1
Dehydration of teeth will be assessed at baseline, at the 5th minute, and at the 10th minute using three different evaluation techniques.
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Digital photographs will be taken at baseline and post-procedure under the fluorescence light source (Ashur plaque indicator (405 nm).
Images will be captured with a Sony Alpha 7iii (Sony, Japan) digital camera equipped with a 90-mm macro lens.
Camera settings will be adjusted for the Ashur device (1/125, f/22, ISO 25600).
To ensure standardization all images will be captured in a dark room.
Digital photographs will be taken at baseline and post-procedure under the fluorescence light source (Led lights (365 nm).
Images will be captured with a Sony Alpha 7iii (Sony, Japan) digital camera equipped with a 90-mm macro lens.
Camera settings will be adjusted for the LED lights (1/125, f/22, ISO 8000).
To ensure standardization, the LED lights will be stabilized on the flash brackets at a 45° angle on both sides, and all images will be captured in a dark room.
The images obtained using the QLF (Quantitative Light-Induced Fluorescence- 405 nm) device will be recorded.
QLF images will be obtained with its own camera.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digital photograph with Ashur plaque indicator
Time Frame: baseline
|
Digital photographs will be taken at baseline and post-procedure under the fluorescence light source (Ashur plaque indicator (405 nm).
Images will be captured with a Sony Alpha 7iii (Sony, Japan) digital camera equipped with a 90-mm macro lens.
Camera settings will be adjusted for the Ashur device (1/125, f/22, ISO 25600).
To ensure standardization all images will be captured in a dark room.
|
baseline
|
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Digital photographs with the Led lights (365 nm)
Time Frame: baseline
|
Digital photographs will be taken at baseline and post-procedure under the fluorescence light source (Led lights (365 nm).
Images will be captured with a Sony Alpha 7iii (Sony, Japan) digital camera equipped with a 90-mm macro lens.
Camera settings will be adjusted for the LED lights (1/125, f/22, ISO 8000).
To ensure standardization, the LED lights will be stabilized on the flash brackets at a 45° angle on both sides, and all images will be captured in a dark room.
|
baseline
|
|
The QLF (Quantitative Light-Induced Fluorescence- 405 nm) images
Time Frame: baseline
|
The images obtained using the QLF (Quantitative Light-Induced Fluorescence- 405 nm) device will be recorded.
QLF images will be obtained with its own camera.
All images will be captured in a dark room.
|
baseline
|
|
Digital photograph with Ashur plaque indicator
Time Frame: at 5th minute
|
Digital photographs will be taken at baseline and post-procedure under the fluorescence light source (Ashur plaque indicator (405 nm).
Images will be captured with a Sony Alpha 7iii (Sony, Japan) digital camera equipped with a 90-mm macro lens.
Camera settings will be adjusted for the Ashur device (1/125, f/22, ISO 25600).
To ensure standardization all images will be captured in a dark room.
|
at 5th minute
|
|
Digital photographs with the Led lights (365 nm)
Time Frame: at 5th minute
|
Digital photographs will be taken at baseline and post-procedure under the fluorescence light source (Led lights (365 nm).
Images will be captured with a Sony Alpha 7iii (Sony, Japan) digital camera equipped with a 90-mm macro lens.
Camera settings will be adjusted for the LED lights (1/125, f/22, ISO 8000).
To ensure standardization, the LED lights will be stabilized on the flash brackets at a 45° angle on both sides, and all images will be captured in a dark room.
|
at 5th minute
|
|
The QLF (Quantitative Light-Induced Fluorescence- 405 nm) images
Time Frame: at 5th minute
|
The images obtained using the QLF (Quantitative Light-Induced Fluorescence- 405 nm) device will be recorded.
QLF images will be obtained with its own camera.
All images will be captured in a dark room.
|
at 5th minute
|
|
Digital photograph with Ashur plaque indicator
Time Frame: at 10th minute
|
Digital photographs will be taken at baseline and post-procedure under the fluorescence light source (Ashur plaque indicator (405 nm).
Images will be captured with a Sony Alpha 7iii (Sony, Japan) digital camera equipped with a 90-mm macro lens.
Camera settings will be adjusted for the Ashur device (1/125, f/22, ISO 25600).
To ensure standardization all images will be captured in a dark room.
|
at 10th minute
|
|
Digital photographs with the Led lights (365 nm)
Time Frame: at 10th minute
|
Digital photographs will be taken at baseline and post-procedure under the fluorescence light source (Led lights (365 nm).
Images will be captured with a Sony Alpha 7iii (Sony, Japan) digital camera equipped with a 90-mm macro lens.
Camera settings will be adjusted for the LED lights (1/125, f/22, ISO 8000).
To ensure standardization, the LED lights will be stabilized on the flash brackets at a 45° angle on both sides, and all images will be captured in a dark room.
|
at 10th minute
|
|
The QLF (Quantitative Light-Induced Fluorescence- 405 nm) images
Time Frame: at 10th minute
|
The images obtained using the QLF (Quantitative Light-Induced Fluorescence- 405 nm) device will be recorded.
QLF images will be obtained with its own camera.
All images will be captured in a dark room.
|
at 10th minute
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUDHF-2025-83
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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