Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

Not Applicable

Suspended

• Conditions: Dental Restoration

• Registration Number: NCT04846101
• Lead Sponsor: University of Jordan

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

Study Timeline

• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23
• Study Start: 2024-06
• Primary Completion: 2024-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patient satisfaction	2 years	Patient satisfaction of shade matching of the restoration will be evaluated using visual analogue scale

Trial Locations

Locations (1)

The university ofJordan; 🇯🇴 Amman, Jordan