Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

Sponsor

University of Jordan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04846101

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

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

Primary Outcome Measures

Instrumental Color assessment [2 years]
Color difference between restoration & tooth will be assessed using VITASHADE spectrophotometer
Visual color assessment [2 years]
Color difference between restoration & tooth will be evaluated by independent observers

Secondary Outcome Measures

Patient satisfaction [2 years]
Patient satisfaction of shade matching of the restoration will be evaluated using visual analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

University of Jordan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Susan Hattar, Associate Professor, University of Jordan

ClinicalTrials.gov Identifier:

NCT04846101

Other Study ID Numbers:

RCTomnishade

First Posted:

Apr 15, 2021

Last Update Posted:

Jun 10, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Susan Hattar, Associate Professor, University of Jordan

shade matching, dental material, blending effect

Study Results

No Results Posted as of Jun 10, 2021