Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

NCT04846101 | Suspended

• 1 other identifier: RCTomnishade
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Restoration

Keywords

shade matching, dental material, blending effect

Outcome Measures

Primary Outcomes (2)

• Instrumental Color assessment

  Color difference between restoration \& tooth will be assessed using VITASHADE spectrophotometer

  2 years

• Visual color assessment

  Color difference between restoration \& tooth will be evaluated by independent observers

  2 years

Secondary Outcomes (1)

• Patient satisfaction

  2 years

Study Arms (2)

Anterior restorations using single shade OMNICHROMA composite

EXPERIMENTAL

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; Diagnostic Test: Instrumental Shade Analysis; Other: Visual Shade Analysis; Other: Patient satisfaction

Anterior restorations using multi-shade composite

ACTIVE COMPARATOR

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; Diagnostic Test: Instrumental Shade Analysis; Other: Visual Shade Analysis; Other: Patient satisfaction

Interventions

OMNISHADE OTHER

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

Anterior restorations using single shade OMNICHROMA composite

MULTISHADE OTHER

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

Anterior restorations using multi-shade composite

Instrumental Shade Analysis DIAGNOSTIC_TEST

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

Anterior restorations using multi-shade composite; Anterior restorations using single shade OMNICHROMA composite

Visual Shade Analysis OTHER

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

Anterior restorations using multi-shade composite; Anterior restorations using single shade OMNICHROMA composite

Patient satisfaction OTHER

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

Anterior restorations using multi-shade composite; Anterior restorations using single shade OMNICHROMA composite

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

The university ofJordan

Amman, 11181, Jordan

Location

Related 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.

  PMID: 23851132 BACKGROUND

• 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.

  PMID: 16378637 BACKGROUND

• 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.

  PMID: 16085303 BACKGROUND

• 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.

  PMID: 25242100 BACKGROUND

• 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.

  PMID: 31095870 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blind Observers will be asked to assess the shade matching capacity of the restorative material on a Likert Scale.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start: June 1, 2024
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 2 years

Locations

JO (1)