Color Match Assessment of a Single Shade Structurally Colored Universal Resin Composite
1 other identifier
interventional
21
1 country
1
Brief Summary
Matching the color of resin composite utilized in anterior teeth is believed to be one of the most challenging tasks a dentist has to face in daily practice. The color of the teeth is primary influenced by dentin; on the other hand, enamel has a major influence on the color perception in terms of lightness. In the layering concept, the missing dental tissues are substituted in increments with resin composite of the exact shade as the dental tissue. A translucent composite resin is applied over a more opaque composite resin to achieve a depth perception similar to that of the natural teeth. Which indicates that the visible color is the consequence of diffuse reflectance from the internal dentin or opaque material layer through the external translucent layer. There are numerous elements that make the color matching problematic. These problems arise from the point that color matching rely on many different chromatic properties related to the teeth and resin composite; those include hue, chroma and value; translucency, opalescence and fluorescence; light diffusion and transmission; and luster and texture of the surface. To reach the ideal esthetics, restorative material should mimic the natural tooth in the previously mentioned properties, in addition of having a long time color stability. Massive efforts were achieved over the years to improve the esthetic properties of dental resin composite restorative materials. Recently, a single shade structurally colored universal composite (Omnichroma, Tokuyama Dental) intended for use with most direct restorative clinical cases was introduced in the market. Its manufacturer claimed that it exhibits color change toward the color of the surrounding hard dental tissues. Thus, it has the advantages of improving the esthetic appearance of the restoration, decrease dependence on shade-matching procedures, decrease the number of shade guide tabs, and counteract for color mismatches to some degree. Up till now no studies assessed the color match of Omnichroma resin composite in anterior teeth cavities clinically. Thus, the aim of this clinical trial was to investigate if the single shade structurally colored universal resin composite (OMNICHROMA) will modify its shade to match the tooth structure shade in anterior teeth cavities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 2, 2021
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2021
CompletedAugust 10, 2021
August 1, 2021
4 months
July 2, 2021
August 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
shade matching (digital analysis)
to assess the shade matching of the newly introduced OMNICHROMA resin composite to the tooth structure. Image analysis will be carried out by comparing LAB values using Easyshade spectrophotometer
after 1 week of restorations placement
Secondary Outcomes (1)
shade match acceptance (visual assessment)
after 1 week of restorations placement
Study Arms (1)
a single shade structurally colored universal resin composite
EXPERIMENTALCavities will be prepared. one shade universal composite (Omnichroma) a will be applied according to the manufacturer.
Interventions
Omnichroma is a single shade composite that is claimed to have blending effect with the tooth color, thus eliminate shade matching procedures during restorative treatment
Eligibility Criteria
You may qualify if:
- Patients with carious class V or Class III cavities
- Young adult Males or female
- patient with low or moderate caries risk index
- Co-operative patients approving to participate in the study
You may not qualify if:
- Patients with a compromised medical history
- Severe or active periodontal disease
- Severe medical complications
- Erosive lesions
- Lack of compliance and rampant caries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National research centre
Cairo, 12622, Egypt
Related Publications (1)
Ragain JC, Johnston WM. Color acceptance of direct dental restorative materials by human observers. Color Res Appl. 2000;25(4):278-285. Riad MI, Gamal WM, Morsy AS. Color matching of a single shade structurally colored universal resin composite with the surrounding hard dental tissues. Egyptian Dental Journal; 2020, 66, 2721:2727. Kim BJ, Lee YK. Influence of the shade designation on the color difference between the same shade-designated resin composites by the brand. Dent Mater. 2009;25: 1148-54. Mohamed MA, Afutu R, Tran D, Dunn K, Ghanem J, Perry R and Kugel G. Shade-Matching Capacity of Omnichroma in Anterior Restorations. J Dental Sci 2020, 5(2): 000247. Kevin B. How to match any composite restoration shade: Tokuyama's OMNICHROMA Uses Smart Chromatic Technology to Match a Wider Range of Natural Teeth Colors. Dental Products Report 2019; 53(3): 36.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaymaa M Nagi, pHD
National Research Centre, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant professor in restorative and dental materials department
Study Record Dates
First Submitted
July 2, 2021
First Posted
July 14, 2021
Study Start
April 1, 2021
Primary Completion
August 6, 2021
Study Completion
August 6, 2021
Last Updated
August 10, 2021
Record last verified: 2021-08