Dental DiseasesNCT06473727
Evaluation of the Initial Color Match of Different Single-shade Composites
A study testing Omnichoroma and Charisma Topaz One in people with Dental Diseases, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Diseases
- What is being tested?
- Omnichoroma and Charisma Topaz One
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2023to 16 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Maintain satisfactory oral hygiene
- Have healthy gingival tissues
- Presence of an anterior non-carious cervical lesion approximately 5 m wide
Who cannot join
- Presence of caries
- Signs of fistula
- Pulp exposure
- Periodontal tissue swelling
- Abnormal tooth mobility
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Erciyes University
Kayseri, 38280
About this study
Official title: 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).
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.
- Conditions
- Dental Diseases
- Being tested
- Omnichoroma, Charisma Topaz One
- Keywords
- blending, color match, composite resin, esthetics
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnichoromaOther
Also called Group 1
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.
Charisma Topaz OneOther
Also called Group 2
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.
| Study group | Role | What they receive |
|---|---|---|
| Omnichoroma | Active comparator | Anterior non-carious cervical lesions restored with Omnichoroma single-shade resin composite. Receives: Other: Omnichoroma |
| Charisma Topaz One | Active comparator | Anterior non-carious cervical lesions restored with Charisma Topaz One single-shade resin composite. Receives: Other: Charisma Topaz One |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start24 May 2023
- Primary completion16 May 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Nur Dogan, TC Erciyes University
- Investigators
- Ayse Nur Dogan, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473727
- Sponsor's protocol ID
- ErciyesU-DF-AD-01
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dogan AN, Arslan S. Baseline color-matching in anterior non-carious cervical lesions of patients of two single-shade resin composites: a randomized clinical trial. Odontology. 2026 Mar 7. doi: 10.1007/s10266-026-01349-9. Online ahead of print.
PubMed 41793603
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Initial Color Match of Anterior Non-caries Cervical Lesions Restorated With Different Single-shade Resin Composites: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06473727
- Acronym / sponsor ID
- ErciyesU-DF-AD-01
- Conditions
- Dental Diseases
- Keywords
- blending, color match, composite resin, esthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups
| Arm | Type | Receives |
|---|---|---|
| Omnichoroma | Active comparator | Other: OmnichoromaAnterior non-carious cervical lesions restored with Omnichoroma single-shade resin composite. |
| Charisma Topaz One | Active comparator | Other: Charisma Topaz OneAnterior non-carious cervical lesions restored with Charisma Topaz One single-shade resin composite. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Maintain satisfactory oral hygiene
- Have healthy gingival tissues
- Presence of an anterior non-carious cervical lesion approximately 5 m wide
Key exclusion criteria (5 listed)
- Presence of caries
- Signs of fistula
- Pulp exposure
- Periodontal tissue swelling
- Abnormal tooth mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmnichoromaAlso: Group 1Patients 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 | Omnichoroma |
| Charisma Topaz OneAlso: Group 2Patients 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 | Charisma Topaz One |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 41793603Dogan AN, Arslan S. Baseline color-matching in anterior non-carious cervical lesions of patients of two single-shade resin composites: a randomized clinical trial. Odontology. 2026 Mar 7. doi: 10.1007/s10266-026-01349-9. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Nur Dogan principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnichoroma and Charisma Topaz One in people with Dental Diseases, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color assesment (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.