NCT04960852

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

July 2, 2021

Last Update Submit

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

EXPERIMENTAL

Cavities will be prepared. one shade universal composite (Omnichroma) a will be applied according to the manufacturer.

Other: a single shade structurally colored universal resin composite

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

a single shade structurally colored universal resin composite

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

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

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Shaymaa M Nagi, pHD

    National Research Centre, Egypt

    PRINCIPAL INVESTIGATOR

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

Locations