NCT04817579

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
3.3 years until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

March 13, 2021

Last Update Submit

June 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Immediately after crowns try-in. The crown with the best result will be instantly cemented.

Secondary Outcomes (1)

  • Shade match using modified USPHS criteria

    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.

Study Arms (3)

Conventional visual shade matching

ACTIVE COMPARATOR

Patients requiring single crown in the esthetic zone treated with Conventional visual shade matching (Ivoclar Classic shade guide)

Device: Conventional visual shade matching

Spectrophotometer

EXPERIMENTAL

Patients requiring single crown in the esthetic zone treated with Spectrophotometer (Vita Easy Shade)

Device: Spectrophotometer

Digital photography combined with eLABor_aid shade analyzing software.

EXPERIMENTAL

Patients requiring single crown in the esthetic zone treated with Digital photography combined with eLABor\_aid shade analyzing software.

Device: Digital photography combined with eLABor_aid shade analyzing software

Interventions

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.

Also known as: eLAB protocol
Digital photography combined with eLABor_aid shade analyzing software.

Spectrophotometric measurement methods employing computer calculations, based on color science and theories, allow quantitative evaluation which is objective and appears to be more accurate.

Also known as: Vita Easy-shade
Spectrophotometer

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.

Also known as: Ivoclar classic shade guide
Conventional visual shade matching

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, 11555, Egypt

RECRUITING

MeSH Terms

Conditions

Tooth DiscolorationTooth Fractures

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesTooth InjuriesWounds and Injuries

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Each patient will try in three crowns with different methods for shade matching.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Fixed Prosthodontics Department

Study Record Dates

First Submitted

March 13, 2021

First Posted

March 26, 2021

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations