Evaluation of the Initial Color Match of Different Single-shade Composites

June 25, 2024 updated by: Ayse Nur Dogan, TC Erciyes University

Evaluation of the Initial Color Match of Anterior Non-caries Cervical Lesions Restorated With Different Single-shade Resin Composites: A Randomized Clinical Study

The aim of this study was to evaluate the initial colour match of anterior non-carious cervical lesions restored with different single-shade resin composites, namely Omnichroma (Tokuyama) and Charisma Topaz One (Kulzer).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colour selection for composite restorations is a challenging process influenced by a number of environmental and operator factors. The polychromatic structure of natural teeth presents a challenge to shade selection. Consequently, the prevailing trend towards simplification of shade matching has led to the emergence of single-shade universal composites. Single-shade universal composites are able to replicate the natural colour of teeth by capturing the structural colour based on the size of the filler particles. Unlike other materials, it does not require the use of additional dyes or pigments. The blending, colour induction and colour assimilation effects of resin composites are collectively referred to as the chameleon effect. This phenomenon allows resin-based restorative materials to achieve a shade that closely resembles the colour of the surrounding tooth structure. The intelligent monochromatic composite makes shade selection easier for the clinician and provides a quick and easy way to create aesthetic restorations. Its distinctive character reduces confusion and potentially saves time in the clinic. However, the effectiveness of this material in matching different shades of natural teeth remains uncertain, and there is a paucity of clinical evidence on the efficacy of its colour-matching capabilities in dental restorations.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38280
        • Faculty of Dentistry, Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Maintain satisfactory oral hygiene
  • Have healthy gingival tissues
  • Presence of an anterior non-carious cervical lesion approximately 5 m wide

Exclusion Criteria:

  • Presence of caries
  • Signs of fistula
  • Pulp exposure
  • Periodontal tissue swelling
  • Abnormal tooth mobility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omnichoroma
Anterior non-carious cervical lesions restored with Omnichoroma single-shade resin composite.
Other: Omnichoroma
Patients with anterior non-carious cervical lesions were treated with Omnichoroma. Colour measurements were taken from the middle third of the teeth to be treated using a spectrophotometer. The initial colour measurement was taken from the middle third of the restoration made in the same place and at the same time 24 hours after treatment.
Other Names:
  • Group 1
Active Comparator: Charisma Topaz One
Anterior non-carious cervical lesions restored with Charisma Topaz One single-shade resin composite.
Other: Charisma Topaz One
Patients with anterior non-carious cervical lesions were treated with Charisma Topaz One. Colour measurements were taken from the middle third of the teeth to be treated using a spectrophotometer. The initial colour measurement was taken from the middle third of the restoration made in the same place and at the same time 24 hours after treatment.
Other Names:
  • Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color assesment
Time Frame: 24 hours
The color match of all restorations was evaluated with a spectrophotometer.The values of the coordinates L*, a* and b* in the middle third of the tooth before the restorations and after 24 hours in the middle third of the restorations were evaluated using a digital spectrophotometer. The colour difference (ΔE00) was calculated using an Excel spreadsheet with parametric factors set to 1.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Ayse Nur Dogan, TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Actual)

May 16, 2024

Study Completion (Actual)

June 16, 2024

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ErciyesU-DF-AD-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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