Dental Photography and Numeric Shade Quantification as a Substitute to Conventional and Instrumental Shade Matching Techniques in the Esthetic Zone
Primary Purpose
Discoloration, Tooth, Chip Tooth, Non Vital Teeth
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Digital photography combined with eLABor_aid shade analyzing software
Spectrophotometer
Conventional visual shade matching
Sponsored by
About this trial
This is an interventional treatment trial for Discoloration, Tooth
Eligibility Criteria
Inclusion Criteria:
- Age range of the patients from 20-50 years old; able to read and sign the informed consent document.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
- Patients with teeth problems indicated for full coverage restoration (e.g. moderate discoloration, coronal fracture where partial coverage would lack retention, mal-posed or malformed teeth, esthetics enhancement of previously placed crown) where the contralateral/adjacent tooth is present.
- Patients with root canal treated teeth requiring full coverage restorations even if they need fiber post and core fabrication first.
Exclusion criteria are:
- Patients with poor oral hygiene and motivation.
- Patients with teeth with increased incisal translucency.
- Patients with severe discolored teeth.
- Patients with smoking habits.
- Patients with excessive consumption of coffee or tea.
- Pregnant women to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
- Patients with psychiatric problems or unrealistic expectation (patient that has phobia from dental treatments or needle injection).
- Patients suffer from para-functional habits.
Sites / Locations
- Faculty of dentistry, Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Conventional visual shade matching
Spectrophotometer
Digital photography combined with eLABor_aid shade analyzing software.
Arm Description
Patients requiring single crown in the esthetic zone treated with Conventional visual shade matching (Ivoclar Classic shade guide)
Patients requiring single crown in the esthetic zone treated with Spectrophotometer (Vita Easy Shade)
Patients requiring single crown in the esthetic zone treated with Digital photography combined with eLABor_aid shade analyzing software.
Outcomes
Primary Outcome Measures
Color difference (Delta E) calculated using calibrated images on photoshop software
Photoshop combined with dental photography using Delta E formula. Standardized images will be taken using a standardized protocol and a grey card to calibrate the produced images to ensure standard exposure in all photos. Delta E will be calculated using photoshop software.
Delta E (ΔE) = [(L1 - L2)² + (a1 - a2)² + (b1 - b2)²]1/2
Secondary Outcome Measures
Shade match using modified USPHS criteria
Alpha (Excellent): ideal. Bravo (Acceptable): less than ideal but no modifications required Charlie (Acceptable but modifications needed): staining or other shade modifications required.
Delta (Unacceptable): remake.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04817579
Brief Title
Dental Photography and Numeric Shade Quantification as a Substitute to Conventional and Instrumental Shade Matching Techniques in the Esthetic Zone
Official Title
Dental Photography and Numeric Shade Quantification as a Substitute to Conventional and Instrumental Shade Matching Techniques in the Esthetic Zone: A Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Visual shade matching is the most common method, in which a color standard from a commercially available dental shade guide is compared to and matched with the target tooth. However, several factors can contribute to perception errors including: different lighting variables, multiple shade systems available in the market with lack of standardization in color systems and corresponding porcelain systems, individual human variables in color perception and lack of understanding of color science.
Therefore, in order to eliminate the uncontrolled variables during the color matching process, instrumental methods have been developed. Spectrophotometric measurement methods employing computer calculations, based on color science and theories, allow quantitative evaluation which is objective and appears to be more accurate. However, extremely high costs, relatively low performance with respect to agreements of the computer-aided devices, and edge loss error make it less acceptable.
One of the most powerful tools in communicating with both patients and dental ceramists is digital photography. Hence, this study is designed to explore the possibilities of a novel approach to shade management (eLABor_aid) utilizing a photocolorimetric (PCM) method and subsequent shade formulation without the use of stock shade guides in comparison to well-known visual and instrumental methods.
The aim of the study is to evaluate the accuracy of digital photography combined with shade analyzing software (eLAB) in optimizing shade matching when compared to conventional and instrumental methods of shade selection.
A Null Hypothesis is suggested where no significant difference regarding shade selection between eLAB protocol, conventional and instrumental methods will be found.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoloration, Tooth, Chip Tooth, Non Vital Teeth, Trauma Dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each patient will try in three crowns with different methods for shade matching.
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional visual shade matching
Arm Type
Active Comparator
Arm Description
Patients requiring single crown in the esthetic zone treated with Conventional visual shade matching (Ivoclar Classic shade guide)
Arm Title
Spectrophotometer
Arm Type
Experimental
Arm Description
Patients requiring single crown in the esthetic zone treated with Spectrophotometer (Vita Easy Shade)
Arm Title
Digital photography combined with eLABor_aid shade analyzing software.
Arm Type
Experimental
Arm Description
Patients requiring single crown in the esthetic zone treated with Digital photography combined with eLABor_aid shade analyzing software.
Intervention Type
Device
Intervention Name(s)
Digital photography combined with eLABor_aid shade analyzing software
Other Intervention Name(s)
eLAB protocol
Intervention Description
ELABor_aid is a new approach to objective shade communication and shade reproduction in dentistry, based on numeric quantification obtained from standardized RGB (red-green-blue) images, and the formulation of a patient personal shade recipe using trichromatic subtractive color mixing laws, thus abandoning the use of visual assessment and shade guides entirely. This approach is currently enjoying increasing popularity for its ease of use, reliability as well as for its practically oriented features like its imaging ability or the digital try-in.
Intervention Type
Device
Intervention Name(s)
Spectrophotometer
Other Intervention Name(s)
Vita Easy-shade
Intervention Description
Spectrophotometric measurement methods employing computer calculations, based on color science and theories, allow quantitative evaluation which is objective and appears to be more accurate.
Intervention Type
Device
Intervention Name(s)
Conventional visual shade matching
Other Intervention Name(s)
Ivoclar classic shade guide
Intervention Description
Visual shade matching is the most common method, in which a color standard from a commercially available dental shade guide is compared to and matched with the target tooth.
Primary Outcome Measure Information:
Title
Color difference (Delta E) calculated using calibrated images on photoshop software
Description
Photoshop combined with dental photography using Delta E formula. Standardized images will be taken using a standardized protocol and a grey card to calibrate the produced images to ensure standard exposure in all photos. Delta E will be calculated using photoshop software.
Delta E (ΔE) = [(L1 - L2)² + (a1 - a2)² + (b1 - b2)²]1/2
Time Frame
Immediately after crowns try-in. The crown with the best result will be instantly cemented.
Secondary Outcome Measure Information:
Title
Shade match using modified USPHS criteria
Description
Alpha (Excellent): ideal. Bravo (Acceptable): less than ideal but no modifications required Charlie (Acceptable but modifications needed): staining or other shade modifications required.
Delta (Unacceptable): remake.
Time Frame
Immediately after Try-in stage. Each crown will be seated in the patient's mouth and a score will be given by a blinded assessor. The crown with the best shade match will be finally cemented.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range of the patients from 20-50 years old; able to read and sign the informed consent document.
Patients able physically and psychologically to tolerate conventional restorative procedures.
Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
Patients with teeth problems indicated for full coverage restoration (e.g. moderate discoloration, coronal fracture where partial coverage would lack retention, mal-posed or malformed teeth, esthetics enhancement of previously placed crown) where the contralateral/adjacent tooth is present.
Patients with root canal treated teeth requiring full coverage restorations even if they need fiber post and core fabrication first.
Exclusion criteria are:
Patients with poor oral hygiene and motivation.
Patients with teeth with increased incisal translucency.
Patients with severe discolored teeth.
Patients with smoking habits.
Patients with excessive consumption of coffee or tea.
Pregnant women to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
Patients with psychiatric problems or unrealistic expectation (patient that has phobia from dental treatments or needle injection).
Patients suffer from para-functional habits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada F Shehab
Phone
+201223402909
Email
nada.farid@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of dentistry, Cairo University
City
Cairo
ZIP/Postal Code
11555
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reham El basty, Ass. Prof.
12. IPD Sharing Statement
Learn more about this trial
Dental Photography and Numeric Shade Quantification as a Substitute to Conventional and Instrumental Shade Matching Techniques in the Esthetic Zone
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