Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-09-30

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).

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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

Conditions

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Dental Restoration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Blind Observers will be asked to assess the shade matching capacity of the restorative material on a Likert Scale.

Study Groups

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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.

Group Type EXPERIMENTAL

OMNISHADE

Intervention Type OTHER

Anterior dental cavities (Class III, Class IV) will be restored with an omnishade composite material

Instrumental Shade Analysis

Intervention Type DIAGNOSTIC_TEST

Assessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration

Visual Shade Analysis

Intervention Type OTHER

Visual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration

Patient satisfaction

Intervention Type OTHER

Patient satisfaction of the final shade match will be assessed on a visual analogue scale

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.

Group Type ACTIVE_COMPARATOR

MULTISHADE

Intervention Type OTHER

Anterior dental cavities (Class III, Class IV) will be restored with conventional multishade composite material.

Instrumental Shade Analysis

Intervention Type DIAGNOSTIC_TEST

Assessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration

Visual Shade Analysis

Intervention Type OTHER

Visual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration

Patient satisfaction

Intervention Type OTHER

Patient satisfaction of the final shade match will be assessed on a visual analogue scale

Interventions

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OMNISHADE

Anterior dental cavities (Class III, Class IV) will be restored with an omnishade composite material

Intervention Type OTHER

MULTISHADE

Anterior dental cavities (Class III, Class IV) will be restored with conventional multishade composite material.

Intervention Type OTHER

Instrumental Shade Analysis

Assessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration

Intervention Type DIAGNOSTIC_TEST

Visual Shade Analysis

Visual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration

Intervention Type OTHER

Patient satisfaction

Patient satisfaction of the final shade match will be assessed on a visual analogue scale

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes