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CompletedNCT06473727Updated Jun 26, 2024

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

An interventional study of Omnichoroma and Charisma Topaz One in Dental Diseases, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by TC Erciyes University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled May 2023, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Dental Diseases

Keywords

  • blending
  • color match
  • composite resin
  • esthetics
03

In context

Stomatognathic Diseases

110 studies on the registry are indexed under Stomatognathic Diseases; 26 are open to participants now.

This study's enrollment of 60 is close to the median of 59 across 86 interventional studies indexed under Stomatognathic Diseases.

Browse Stomatognathic Diseases studies →

Lead sponsor

TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Presence of caries
  • Signs of fistula
  • Pulp exposure
  • Periodontal tissue swelling
  • Abnormal tooth mobility
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Omnichoroma

    Anterior non-carious cervical lesions restored with Omnichoroma single-shade resin composite.

    Other: Omnichoroma

  • Active comparator
    Charisma Topaz One

    Anterior non-carious cervical lesions restored with Charisma Topaz One single-shade resin composite.

    Other: Charisma Topaz One

Interventions

  • OtherOmnichoroma

    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.

    Also known as: Group 1

  • OtherCharisma 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.

    Also known as: Group 2

06

What researchers measure

Primary outcomes

  1. Color assesment

    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.

    Time frame: 24 hours

07

Study locations

1 site
  • Faculty of Dentistry, Erciyes University
    Kayseri, 38280, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06473727
Lead sponsor
TC Erciyes University
Responsible party
Ayse Nur Dogan (Lecturer, TC Erciyes University) — Principal investigator
First posted
Jun 25, 2024
Start date
May 24, 2023
Primary completion
May 16, 2024
Completion
Jun 16, 2024
Last update
Jun 26, 2024

Study contacts

Ayse Nur Dogan
principal investigator · TC Erciyes University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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