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Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

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ClinicalTrials.gov Identifier: NCT04846101
Recruitment Status : Not yet recruiting
First Posted : April 15, 2021
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Susan Hattar, University of Jordan

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Dental Restoration Other: OMNISHADE Other: MULTISHADE Diagnostic Test: Instrumental Shade Analysis Other: Visual Shade Analysis Other: Patient satisfaction Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Blind Observers will be asked to assess the shade matching capacity of the restorative material on a Likert Scale.
Primary Purpose: Treatment
Official Title: Evaluation of Shade Matching Capacity of a Single-shade Contemporary Resin Composite in Anterior Restorations
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024
Arms and Interventions
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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.
 Other: MULTISHADE
Anterior dental cavities (Class III, Class IV) will be restored with conventional multishade 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


Outcome Measures
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Primary Outcome Measures :
  1. Instrumental Color assessment [ Time Frame: 2 years ]
    Color difference between restoration & tooth will be assessed using VITASHADE spectrophotometer

  2. Visual color assessment [ Time Frame: 2 years ]
    Color difference between restoration & tooth will be evaluated by independent observers


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 2 years ]
    Patient satisfaction of shade matching of the restoration will be evaluated using visual analogue scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846101


Contacts
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Contact: Susan Hattar, PhD 00962795642613 susanhattar@yahoo.fr

Sponsors and Collaborators
University of Jordan
More Information
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Publications:

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Responsible Party: Susan Hattar, Associate Professor, University of Jordan
ClinicalTrials.gov Identifier: NCT04846101    
Other Study ID Numbers: RCTomnishade
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available for other researchers
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 2 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Hattar, University of Jordan:
shade matching, dental material, blending effect