Tooth DiscolorationNCT06125132
Evaluation of 2-year Clinical Performance of Two Different Single Color Universal Composite Resin Restorative Materials.
A study testing Restoration with-tooth colored material in people with Tooth Discoloration and Tooth Wear, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Dentists have recently preferred to use composite materials and restorative techniques that allow the use of simplified clinical protocols in order to reduce the time the patient spends in the dentist's chair and minimize technical sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Tooth Wear
- What is being tested?
- Restoration with-tooth colored material
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 3 teeth with cervical abrasion
- Volunteerily enrolling
Who cannot join
- No bruxism
- No carious formation in worn teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of 2-year Clinical Performance of Two Different Single Color Universal Composite Resin Restorative Materials: A Double-blind Prospective Randomized Controlled Trial.
Dentists have recently preferred to use composite materials and restorative techniques that allow the use of simplified clinical protocols in order to reduce the time the patient spends in the dentist's chair and minimize technical sensitivity. Color selection in the clinic is a very sensitive process and is affected by environmental factors and operator-related variables. This has led to the development of single-color universal composite resins that aim to facilitate color selection. These materials have a universal opacity and several Vita shades and are recommended by manufacturers to be used in a single color layer that can match different tooth colors. In recent years, monochromatic universal composites have been developed that are supposed to be compatible with all Vita Classic Scale shades from A1 to D4. Manufacturers report that single-color universal composites can be applied to teeth of all colors without using the layering technique using different color composites.
Therefore, the aim of this study is to compare the clinical performance of 2 different single-color universal composite resin materials (OMNICHROMA and Zenchroma) in the restoration of non-carious cervical lesions with the control group (Filtek Z250, 3M), which is a multi-color composite resin material, using modified US Public Health Service (USPHS) and World Dental Federation (FDI) criteria.
Read the detailed description
Dentists have recently preferred to use composite materials and restorative techniques that allow the use of simplified clinical protocols in order to reduce the time the patient spends in the dentist's chair and minimize technical sensitivity. Color selection in the clinic is a very sensitive process and is affected by environmental factors and operator-related variables. This has led to the development of single-color universal composite resins that aim to facilitate color selection. These materials have a universal opacity and several Vita shades and are recommended by manufacturers to be used in a single color layer that can match different tooth colors. In recent years, monochromatic universal composites have been developed that are supposed to be compatible with all Vita Classic Scale shades from A1 to D4. Manufacturers report that single-color universal composites can be applied to teeth of all colors without using the layering technique using different color composites.
OMNICHROMA (Tokuyama Dental) is the first universal composite resin restorative material that is claimed to aesthetically match every tooth color from A1 to D4 in a single shade. The manufacturer declares that OMNICHROMA, with its equally sized supra-nano spherical filler (260 nm spherical silicon dioxide-Zzirconium dioxide), adapts to each of the 16 VITA classic colors thanks to Smart Chromatic Technology.
Zenchroma (President Dental) is a hybrid composite material containing an ultra-thin, radiopaque glass filler. The manufacturer declares that the filling color perfectly adapts to the tooth structure with its chameleon effect.
As we know, there is no study investigating the clinical performance of these two universal composites. The aim of this study is to compare the clinical performance of 2 different single-color universal composite resin materials (OMNICHROMA and Zenchroma) in the restoration of non-carious cervical lesions with the control group (Filtek Z250, 3M), which is a multi-color composite resin material, using modified USPHS and FDI criteria.
In this study, two different null hypotheses were established. The first null hypothesis of this study is; It is concluded that there is no difference between 2 different single color universal composite resin materials (OMNICHROMA and Zenchroma) in terms of clinical performance in restorations of non-carious cervical lesions. The second null hypothesis of the study is that universal composite resin materials are not different from the control group, multicolored composite resin (Filtek Z250, 3M), in terms of clinical performance in restorations of non-carious cervical lesions.
- Conditions
- Tooth Discoloration, Tooth Wear
- Being tested
- Restoration with-tooth colored material
- Keywords
- one-shade composites, single-shade composites, universal composites
- Medical subject headings
- Tooth Discoloration, Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration with-tooth colored materialProcedure or surgery
Restoration of abrasions with different composite resin materials
| Study group | Role | What they receive |
|---|---|---|
| OMNICHROMA one shade composite | Active comparator | a one-shade composite resin as experimental group Receives: Procedure: Restoration with-tooth colored material |
| Zen Chroma one shade composite | Active comparator | a one-shade composite resin as experimental group Receives: Procedure: Restoration with-tooth colored material |
| Filtek Z250 multi shade composite | Active comparator | a multi-shade composite resin as control group Receives: Procedure: Restoration with-tooth colored material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance according to the modified United States Public Health Service criteria
Retention, marginal discoloration, marginal adaptation, secondary caries and postoperative sensitivity will be scored as Alpha (the best), Bravo (acceptable) and Charlie (unacceptable).
Measured: 6,12,18, 24 and 36 months
Secondary outcomes (1)
Clinical performance of restorations according to the World Dental Organization criteria
Retention, marginal discoloration, marginal adaptation, secondary caries and postoperative sensitivity will be scored as 1) clinically excellent, 2) clinicallay good, 3) clinically sufficient, 4) clinically unsatisfactory and 5) clinically poor
Measured: 6,12,18, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Oct 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kerimova, Baskent University
- Investigators
- Kıvanç Yamanel, PHD, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125132
- Sponsor's protocol ID
- D-KA22/25
- Status last verified
- Jan 2025
- First submitted
- 27 Oct 2023
- Last updated
- 6 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Abreu JLB, Sampaio CS, Benalcazar Jalkh EB, Hirata R. Analysis of the color matching of universal resin composites in anterior restorations. J Esthet Restor Dent. 2021 Mar;33(2):269-276. doi: 10.1111/jerd.12659. Epub 2020 Sep 29.
PubMed 32989879Durand LB, Ruiz-Lopez J, Perez BG, Ionescu AM, Carrillo-Perez F, Ghinea R, Perez MM. Color, lightness, chroma, hue, and translucency adjustment potential of resin composites using CIEDE2000 color difference formula. J Esthet Restor Dent. 2021 Sep;33(6):836-843. doi: 10.1111/jerd.12689. Epub 2020 Dec 7.
PubMed 33283966Iyer RS, Babani VR, Yaman P, Dennison J. Color match using instrumental and visual methods for single, group, and multi-shade composite resins. J Esthet Restor Dent. 2021 Mar;33(2):394-400. doi: 10.1111/jerd.12621. Epub 2020 Aug 25.
PubMed 32844567Kobayashi S, Nakajima M, Furusawa K, Tichy A, Hosaka K, Tagami J. Color adjustment potential of single-shade resin composite to various-shade human teeth: Effect of structural color phenomenon. Dent Mater J. 2021 Jul 31;40(4):1033-1040. doi: 10.4012/dmj.2020-364. Epub 2021 Apr 20.
PubMed 33883353
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 2-year Clinical Performance of Two Different Single Color Universal Composite Resin Restorative Materials: A Double-blind Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06125132
- Acronym / sponsor ID
- D-KA22/25
- Conditions
- Tooth Discoloration, Tooth Wear
- Keywords
- one-shade composites, single-shade composites, universal composites
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 9 Nov 2023 (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.
Dentists have recently preferred to use composite materials and restorative techniques that allow the use of simplified clinical protocols in order to reduce the time the patient spends in the dentist's chair and minimize technical sensitivity. Color selection in the clinic is a very sensitive process and is affected by environmental factors and operator-related variables. This has led to the development of single-color universal composite resins that aim to facilitate color selection. These materials have a universal opacity and several Vita shades and are recommended by manufacturers to be used in a single color layer that can match different tooth colors. In recent years, monochromatic universal composites have been developed that are supposed to be compatible with all Vita Classic Scale shades from A1 to D4. Manufacturers report that single-color universal composites can be applied to teeth of all colors without using the layering technique using different color composites.
Therefore, the aim of this study is to compare the clinical performance of 2 different single-color universal composite resin materials (OMNICHROMA and Zenchroma) in the restoration of non-carious cervical lesions with the control group (Filtek Z250, 3M), which is a multi-color composite resin material, using modified US Public Health Service (USPHS) and World Dental Federation (FDI) criteria.
Detailed description
Dentists have recently preferred to use composite materials and restorative techniques that allow the use of simplified clinical protocols in order to reduce the time the patient spends in the dentist's chair and minimize technical sensitivity. Color selection in the clinic is a very sensitive process and is affected by environmental factors and operator-related variables. This has led to the development of single-color universal composite resins that aim to facilitate color selection. These materials have a universal opacity and several Vita shades and are recommended by manufacturers to be used in a single color layer that can match different tooth colors. In recent years, monochromatic universal composites have been developed that are supposed to be compatible with all Vita Classic Scale shades from A1 to D4. Manufacturers report that single-color universal composites can be applied to teeth of all colors without using the layering technique using different color composites.
OMNICHROMA (Tokuyama Dental) is the first universal composite resin restorative material that is claimed to aesthetically match every tooth color from A1 to D4 in a single shade. The manufacturer declares that OMNICHROMA, with its equally sized supra-nano spherical filler (260 nm spherical silicon dioxide-Zzirconium dioxide), adapts to each of the 16 VITA classic colors thanks to Smart Chromatic Technology.
Zenchroma (President Dental) is a hybrid composite material containing an ultra-thin, radiopaque glass filler. The manufacturer declares that the filling color perfectly adapts to the tooth structure with its chameleon effect.
As we know, there is no study investigating the clinical performance of these two universal composites. The aim of this study is to compare the clinical performance of 2 different single-color universal composite resin materials (OMNICHROMA and Zenchroma) in the restoration of non-carious cervical lesions with the control group (Filtek Z250, 3M), which is a multi-color composite resin material, using modified USPHS and FDI criteria.
In this study, two different null hypotheses were established. The first null hypothesis of this study is; It is concluded that there is no difference between 2 different single color universal composite resin materials (OMNICHROMA and Zenchroma) in terms of clinical performance in restorations of non-carious cervical lesions. The second null hypothesis of the study is that universal composite resin materials are not different from the control group, multicolored composite resin (Filtek Z250, 3M), in terms of clinical performance in restorations of non-carious cervical lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OMNICHROMA one shade composite | Active comparator | Procedure: Restoration with-tooth colored materiala one-shade composite resin as experimental group |
| Zen Chroma one shade composite | Active comparator | Procedure: Restoration with-tooth colored materiala one-shade composite resin as experimental group |
| Filtek Z250 multi shade composite | Active comparator | Procedure: Restoration with-tooth colored materiala multi-shade composite resin as control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 3 teeth with cervical abrasion
- Volunteerily enrolling
Key exclusion criteria (2 listed)
- No bruxism
- No carious formation in worn teeth
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 |
|---|---|---|
| Restoration with-tooth colored materialRestoration of abrasions with different composite resin materials | Procedure or surgery | Filtek Z250 multi shade composite, OMNICHROMA one shade composite, Zen Chroma one shade composite |
Primary outcome
Clinical performance according to the modified United States Public Health Service criteria
Time frame: 6,12,18, 24 and 36 months
Retention, marginal discoloration, marginal adaptation, secondary caries and postoperative sensitivity will be scored as Alpha (the best), Bravo (acceptable) and Charlie (unacceptable).
1 secondary outcome
Clinical performance of restorations according to the World Dental Organization criteria
Time frame: 6,12,18, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background: PubMed 32989879de Abreu JLB, Sampaio CS, Benalcazar Jalkh EB, Hirata R. Analysis of the color matching of universal resin composites in anterior restorations. J Esthet Restor Dent. 2021 Mar;33(2):269-276. doi: 10.1111/jerd.12659. Epub 2020 Sep 29.
- Background: PubMed 33283966Durand LB, Ruiz-Lopez J, Perez BG, Ionescu AM, Carrillo-Perez F, Ghinea R, Perez MM. Color, lightness, chroma, hue, and translucency adjustment potential of resin composites using CIEDE2000 color difference formula. J Esthet Restor Dent. 2021 Sep;33(6):836-843. doi: 10.1111/jerd.12689. Epub 2020 Dec 7.
- Background: PubMed 32844567Iyer RS, Babani VR, Yaman P, Dennison J. Color match using instrumental and visual methods for single, group, and multi-shade composite resins. J Esthet Restor Dent. 2021 Mar;33(2):394-400. doi: 10.1111/jerd.12621. Epub 2020 Aug 25.
- Background: PubMed 33883353Kobayashi S, Nakajima M, Furusawa K, Tichy A, Hosaka K, Tagami J. Color adjustment potential of single-shade resin composite to various-shade human teeth: Effect of structural color phenomenon. Dent Mater J. 2021 Jul 31;40(4):1033-1040. doi: 10.4012/dmj.2020-364. Epub 2021 Apr 20.
- Zen Chroma Universal CompositeLink provided by the sponsor.
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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.
Kıvanç Yamanel, PHD study director
Baskent 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 Restoration with-tooth colored material in people with Tooth Discoloration and Tooth Wear, run by Baskent 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical performance according to the modified United States Public Health Service criteria (time frame: 6,12,18, 24 and 36 months). 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 NCT06125132, which also lists 4 linked publications.
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 6 Jan 2025.