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Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04846101
Enrollment
30
Registered
2021-04-15
Start date
2024-06-30
Completion date
2026-09-30
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration

Keywords

shade matching, dental material, blending effect

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).

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

Interventions

OTHERPatient satisfaction

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

OTHEROMNISHADE

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

OTHERMULTISHADE

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

DIAGNOSTIC_TESTInstrumental Shade Analysis

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

OTHERVisual Shade Analysis

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

Sponsors

University of Jordan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Instrumental Color assessment2 yearsColor difference between restoration & tooth will be assessed using VITASHADE spectrophotometer
Visual color assessment2 yearsColor difference between restoration & tooth will be evaluated by independent observers

Secondary

MeasureTime frameDescription
Patient satisfaction2 yearsPatient satisfaction of shade matching of the restoration will be evaluated using visual analogue scale

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026