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Color Match Assessment of a Single Shade Structurally Colored Universal Resin Composite

Primary Purpose

Dental Caries (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
a single shade structurally colored universal resin composite
Sponsored by
National Research Centre, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries (Disorder)

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with a compromised medical history
  • Severe or active periodontal disease
  • Severe medical complications
  • Erosive lesions
  • Lack of compliance and rampant caries

Sites / Locations

  • National research centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

a single shade structurally colored universal resin composite

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

shade match acceptance (visual assessment)
shade match acceptance will be evaluated by two observers Color-matching visual scoring (VS) values will be expressed numerically as follows: 1: mismatch/totally unacceptable, 2: Poor-Match/hardly acceptable, 3: Good- Match/acceptable, 4: Close-Match/small-difference, and 5: Exact-Match/no-color-difference.

Full Information

First Posted
July 2, 2021
Last Updated
August 8, 2021
Sponsor
National Research Centre, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04960852
Brief Title
Color Match Assessment of a Single Shade Structurally Colored Universal Resin Composite
Official Title
Color Match Assessment of a Single Shade Structurally Colored Universal Resin Composite: A Single Arm Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
August 6, 2021 (Actual)
Study Completion Date
August 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Participants' recruitment: The patients will be selected from outpatient clinic of National Research Centre (NRC), Cairo; Egypt Eligible patients who agreed to participate in this trial will sign on written informed consents. Clinical procedure Teeth color measurement Each patient first will receive scaling and polishing procedures to clean the teeth surfaces. A total of 45 anterior teeth cavities will be prepared. Before cavity preparation, shade determination will be performed with Vita Easyshade spectrophotometer. The probe tip will be positioned perpendicular and flushed onto the buccal surface of the tooth to get correct measurements. Cavities preparation Appropriate local dental anesthesia (Mepecaine-L) 1mg will be injected preoperatively unless declined by the patient. Treated teeth will be properly isolated and saliva ejector will be utilized. Conservative cavities will be prepared with #330 carbide bur (FG, Dentsply Midwest®) fixed to a high speed hand piece with water coolant system. Cavity preparation will be limited to the removal of caries and the exact cavity form and size will be obtained after caries removal. Each bur will be discarded after 5 preparations. A functional esthetic enamel bevel will be prepared using a fine grained finishing diamond rotary instrument on the facial surface, the bevel enables harmonious shade transition from composite to tooth substance. - Application of the adhesive system and resin composite in the prepared cavities Enamel of the prepared cavities will be etched using UltraEtch (Ultradent, 40% phosphoric acid) for 30 seconds. After rinsing with water and air drying, the bonding agent will be applied according to the manufacturer's instructions to the cavity using a brush then air-thinned gently and light-cured for 20 seconds. Omnichroma resin composite will be packed in the prepared cavities using a Teflon coated plastic instrument and the restoration will covered with celluloid strip to reduce the oxygen inhibition layer and to get a smooth surface, then light-cured for 40 sec. Excess material will be removed with scalpel. Finishing and polishing will be performed for the anatomical contouring and smoothing of the restorations surfaces using all grates of soflex discs, fine and Extra fine diamond burs, medium and fine rubber polishing points. Color assessment Color match data will be recorded for the restoration after one week. The restorations will be gently dried with cotton and the color values of them will be recorded using the Vita Easyshade spectrophotometer. The color changes (ΔE) will be calculated from the changes in CIE L, a, and b values (ΔL, Δa, Δb) as follows: ΔE= [(ΔL)2 + (Δa)2 + (Δb)2]1/2 CIE Lab is expressed by the L coordinate representing color luminosity, varying from white to black, a and b coordinates representing the chromaticity of the color, with axes varying from green to red and blue to yellow, respectively. The mean of the values obtained will be calculated, and the L, a, and b parameters will be determined. Visual assessment Visual assessment will be performed by two independent observers with normal color vision as checked by Ishiara test. To determine the color-matching between the restorations and the teeth. Color-matching visual scoring (VS) values will be expressed numerically as follows: 1: mismatch/totally unacceptable, 2: Poor-Match/hardly acceptable, 3: Good- Match/acceptable, 4: Close-Match/small-difference, and 5: Exact-Match/no-color-difference. All observers will be trained in color-matching and taught about the used grading system before the assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
a single shade structurally colored universal resin composite
Arm Type
Experimental
Arm Description
Cavities will be prepared. one shade universal composite (Omnichroma) a will be applied according to the manufacturer.
Intervention Type
Other
Intervention Name(s)
a single shade structurally colored universal resin composite
Intervention Description
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
Primary Outcome Measure Information:
Title
shade matching (digital analysis)
Description
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
Time Frame
after 1 week of restorations placement
Secondary Outcome Measure Information:
Title
shade match acceptance (visual assessment)
Description
shade match acceptance will be evaluated by two observers Color-matching visual scoring (VS) values will be expressed numerically as follows: 1: mismatch/totally unacceptable, 2: Poor-Match/hardly acceptable, 3: Good- Match/acceptable, 4: Close-Match/small-difference, and 5: Exact-Match/no-color-difference.
Time Frame
after 1 week of restorations placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with a compromised medical history Severe or active periodontal disease Severe medical complications Erosive lesions Lack of compliance and rampant caries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaymaa M Nagi, pHD
Organizational Affiliation
National Research Centre, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
National research centre
City
Cairo
ZIP/Postal Code
12622
Country
Egypt

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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Color Match Assessment of a Single Shade Structurally Colored Universal Resin Composite

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