Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

January 21, 2024 updated by: Susan Hattar, University of Jordan

Evaluation of Shade Matching Capacity of a Single-shade Contemporary Resin Composite in Anterior Restorations

One of the main difficulties encountered in esthetic dentistry is the complexity associated with shade matching and layering technique to achieve optimal esthetic outcomes. To ensure an esthetic outcome, an imperceptible match of the color of the restorative material to that of the tooth is of utmost importance. Recently, a new shade matching composite that utilizes "smart chromatic technology", developed by Tokuyama was claimed to be able to capture the structural color of its surroundings teeth. Our main objective is to assess the blending capacity of OMNICHROMA composite material in anterior restorations of patients attending the Jordan University Hospital. Both visual and instrumental measurements will be performed and the differences between the shade of the composite resin and the tooth structure will be measured. In addition, multi chroma composite restorations will be placed for the purpose of comparison (control).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

In the present study, the restorations will be placed under rubber dam isolation for moisture control. The cavities will be prepared according to the concepts of minimal invasive dentistry. Prior to placing the composite resin, the margins of the cavities will be finished using ultra fine grit diamond burs·and beveled in a 1-mm area. Deep cavities suspected to be near the pulp be lined with RMGI. Inclusion criteria: class Ill and Class IV carious lesions.

The enamel margins of the cavities will be acid etched for 60s with 37% phosphoric acid and then rinsed thoroughly with water spray. Afterwards, the dentin bonding system will be applied, left undisturbed for 20 s and then excess removed using an air syringe and light cured for 20s. The restorative composite material will be placed in incremental layers, adapted, each layer cured for 40s. After polymerization, the restorations will be finished under profuse water spray using diamonds, Sof-Lex finishing discs and polishers.

All restorations will be placed by one dentist (Pl). Written informed consent will be provided to all participants prior to starting the treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • 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

  • Jordan
      • Amman, Jordan, 11181
        • The university ofJordan

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy patients
  • Patients requiring anterior restorations
  • Vital teeth
  • Absence of periodontal or pulpal disease
  • Patients willing to sign informed consent and returning for follow up

Exclusion Criteria:

  • Patients with extensive caries and tooth loss
  • Patient with periodontal disease
  • Patients with poor oral hygiene and lack of motivation
  • Patient with severe extrinsic or intrinsic discolorations

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anterior restorations using single shade OMNICHROMA composite
Anterior class III and Class IV cavities will be restored using single shade composite material according to standard protocols of etching, bonding and composite placement.
Other: OMNISHADE
Anterior dental cavities (Class III, Class IV) will be restored with an omnishade composite material
Diagnostic test: Instrumental Shade Analysis
Assessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration
Other: Visual Shade Analysis
Visual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration
Other: Patient satisfaction
Patient satisfaction of the final shade match will be assessed on a visual analogue scale
Active Comparator: Anterior restorations using multi-shade composite
Shade selection for the tooth will be performed prior to the placement of the restoration. Anterior class III and Class IV cavities will be restored using multi-shade composite material according to standard protocols of etching, bonding and composite placement.
Diagnostic test: Instrumental Shade Analysis
Assessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration
Other: Visual Shade Analysis
Visual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration
Other: Patient satisfaction
Patient satisfaction of the final shade match will be assessed on a visual analogue scale
Other: MULTISHADE
Anterior dental cavities (Class III, Class IV) will be restored with conventional multishade composite material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumental Color assessment
Time Frame: 2 years
Color difference between restoration & tooth will be assessed using VITASHADE spectrophotometer
2 years
Visual color assessment
Time Frame: 2 years
Color difference between restoration & tooth will be evaluated by independent observers
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 2 years
Patient satisfaction of shade matching of the restoration will be evaluated using visual analogue scale
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCTomnishade

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available for other researchers

IPD Sharing Time Frame

2 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • 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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