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Shade Matching of Omnichroma (One Shade Universal Composite) Versus a Microhybrid Composite in Class V Restorations.

NCT04129047 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-10-16

No results posted yet for this study

Summary

Background Resin composites are effective in restoring damaged teeth due to their good esthetics, high surface gloss, and clinically acceptable wear resistance1. One of the most challenging tasks a dentist has to confront in daily practice is matching the color of composite restorations used in anterior teeth2.

Problem The shade selection is carried out subjectively with a visual shade guide and generally under inadequate light conditions, which can lead to errors in color perception3. The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult.4. Not only that, but there was also mismatch between composite shades and the proprietary shade guides included with the composite kits 5. A mock-up should be performed as a trial to assist in shade selection and ensure the predictability of the esthetic result in restorative treatment6.

Rationale Shade matching has been a time consuming procedure. Recommendations were made to make customized shade guides of the used composite material for more predictable results7. Manufacturers have been aiming at providing materials with a blending effect; taking on the color appearance from surrounding tooth structure 8. Introduction of Omnichroma by Tokuyama is aiming at eliminating the shade taking procedure by providing a single shade universal composite that is designed to blend with the surrounding tooth structure without the need for a shade matching procedure.

Aim The aim of this study is to evaluate the shade matching ability of a new single shade composite (Omnichroma; Tokuyama) compared to a conventional multiple shade microhybrid composite in the restoration of class V restorations using USPHS criteria

Conditions

  • Class V Restorations

Interventions

DRUG

Omnichroma (one shade universal) composite by Tokuyama

Omnichroma is a single shade composite that is intended to have a color blending potential. It eliminates the shade matching procedures and makes it easier to avoid individual errors in shade matching in composite restorations.

DRUG

A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA

a multiple shade universal composite that needs prior shade selection procedure

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-20
Primary Completion
2020-04-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04129047 on ClinicalTrials.gov