Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

Study Overview
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Brief Summary
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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).

Detailed Description
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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

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

Conditions
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Dental Restoration

Intervention / Treatment
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* Other: OMNISHADE
* Other: MULTISHADE
* Diagnostic Test: Instrumental Shade Analysis
* Other: Visual Shade Analysis
* Other: Patient satisfaction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anterior restorations using single shade OMNICHROMA composite<br>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<br>* Anterior dental cavities (Class III, Class IV) will be restored with an omnishade composite material<br>Diagnostic Test: Instrumental Shade Analysis<br>* Assessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration<br>Other: Visual Shade Analysis<br>* Visual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration<br>Other: Patient satisfaction<br>* Patient satisfaction of the final shade match will be assessed on a visual analogue scale<br>|
| Active Comparator: Anterior restorations using multi-shade composite<br>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<br>* Anterior dental cavities (Class III, Class IV) will be restored with conventional multishade composite material.<br>Diagnostic Test: Instrumental Shade Analysis<br>* Assessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration<br>Other: Visual Shade Analysis<br>* Visual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration<br>Other: Patient satisfaction<br>* Patient satisfaction of the final shade match will be assessed on a visual analogue scale<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shade matching, dental material, blending effect