NCT06473727

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 19, 2024

Last Update Submit

June 25, 2024

Conditions

Keywords

blendingcolor matchcomposite resinesthetics

Outcome Measures

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.

    24 hours

Study Arms (2)

Omnichoroma

ACTIVE COMPARATOR

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

Other: Omnichoroma

Charisma Topaz One

ACTIVE COMPARATOR

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

Other: Charisma Topaz One

Interventions

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
Omnichoroma

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
Charisma Topaz One

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Erciyes University

Kayseri, 38280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

  • Ayse Nur Dogan

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

May 24, 2023

Primary Completion

May 16, 2024

Study Completion

June 16, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations