Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

Dental Restoration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04846101
• Other study ID #: RCTomnishade
• Status: Suspended
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2026

Study information

• Verified date: January 2024
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: September 2026
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Restoration

Intervention

Other:
• OMNISHADE
Anterior dental cavities (Class III, Class IV) will be restored with an omnishade composite material
• 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
• Patient satisfaction
Patient satisfaction of the final shade match will be assessed on a visual analogue scale

Locations

Country	Name	City	State
Jordan	The university ofJordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

References & Publications (5)

Mikhail SS, Schricker SR, Azer SS, Brantley WA, Johnston WM. Optical characteristics of contemporary dental composite resin materials. J Dent. 2013 Sep;41(9):771-8. doi: 10.1016/j.jdent.2013.07.001. Epub 2013 Jul 12. — View Citation

Paravina RD, Westland S, Imai FH, Kimura M, Powers JM. Evaluation of blending effect of composites related to restoration size. Dent Mater. 2006 Apr;22(4):299-307. doi: 10.1016/j.dental.2005.04.022. Epub 2005 Aug 8. — View Citation

Paravina RD, Westland S, Kimura M, Powers JM, Imai FH. Color interaction of dental materials: blending effect of layered composites. Dent Mater. 2006 Oct;22(10):903-8. doi: 10.1016/j.dental.2005.11.018. Epub 2005 Dec 27. — View Citation

Pereira Sanchez N, Powers JM, Paravina RD. Instrumental and visual evaluation of the color adjustment potential of resin composites. J Esthet Restor Dent. 2019 Sep;31(5):465-470. doi: 10.1111/jerd.12488. Epub 2019 May 16. — View Citation

Tanaka A, Nakajima M, Seki N, Foxton RM, Tagami J. The effect of tooth age on colour adjustment potential of resin composite restorations. J Dent. 2015 Feb;43(2):253-60. doi: 10.1016/j.jdent.2014.09.007. Epub 2014 Sep 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Instrumental Color assessment	Color difference between restoration & tooth will be assessed using VITASHADE spectrophotometer	2 years
Primary	Visual color assessment	Color difference between restoration & tooth will be evaluated by independent observers	2 years
Secondary	Patient satisfaction	Patient satisfaction of shade matching of the restoration will be evaluated using visual analogue scale	2 years