Dental Caries Class IINCT06563128
Clinical Success of Single-Color Universal Resin Composites
A study testing Clearfil Majesty Posterior, Omnichroma Universal Group and Zen Universal Group in people with Dental Caries Class II, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
According to FDI criteria, the success of 4 different universal resin composites was targeted. In our study, a total of 180 teeth will be restored in class 2 cavities with 5 different composite resins in 5 groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Class II
- What is being tested?
- Clearfil Majesty Posterior, Omnichroma Universal Group and Zen Universal Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2024to 27 Nov 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient should not have any systemic disease.
- You must be 18 years of age or older.
- The patient must have good periodontal health.
- Must have acceptable oral hygiene.
- The teeth to be restored must be symptom-free and vital.
- The mesial and distal surfaces of the teeth to be restored must be in contact with the proximal teeth.
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- The tooth to be restored must be in occlusion with its antagonist.
- The tooth to be restored must have a class 2 caries lesion radiographically not exceeding 2/3 of the dentin.
- Patients with caries have an ICDAS 3-4 score.
- Voluntary acceptance to participate in the study after being informed about the study.
Who cannot join
- The patient has any systemic disease.
- Previously adhered restoration and endodontic treatment on the tooth to be restored.
- Poor periodontal health of the patient.
- Poor oral hygiene.
- The patient is pregnant or breastfeeding.
- The patient is undergoing orthodontic treatment.
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- The patient has bruxism (tooth clenching) and a dry mouth.
- The teeth are devitalised.
- The patient refused to participate in the study after being informed about the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry Department of Restorative Dentistry Clinic
Erzurum, 25050
About this study
Official title: Evaluation of the Clinical Success of Single Colour Universal Resin Composites
According to FDI criteria, the success of 4 different universal resin composites was targeted. In our study, a total of 180 teeth will be restored in class 2 cavities with 5 different composite resins in 5 groups.
Read the detailed description
The study will be conducted in the clinic of the Atatürk University Faculty of Dentistry, Department of Restorative Dental Treatment. After the participants fulfil the inclusion criteria, no interventional procedures other than the treatments routinely applied in the clinic will be performed. Participants who apply to the clinic with the need for dental caries treatment will be included in the study if they accept it. Before the treatment, anamnesis will be taken from the participants, and their information (age, gender) will be recorded. If necessary, local anaesthesia will be applied before or after opening the cavity. If anaesthesia is applied, they will be asked whether they feel numbness. In the study, a total of 180 teeth in 5 groups will be restored with 5 different composite resins.
Group 1: Omnichroma Group 2: Vittra Aps Unique Group 3: OneShade Group 4: Charisma Diamond Group 5: Clearfil Majesty Posterior
Then, the cavity will be prepared by using diamond rond and steel rond drills in class 2 cavity preparation. After the enamel surfaces of the teeth are roughened and washed with 37% orthophosphoric acid for 30 seconds, the necessary isolation will be provided with cotton pellets and saliva absorbent. Teeth will be fixed with matrix band and wedge systems. The adhesive bond system will be applied to all surfaces of the cavity with a bonding brush according to the manufacturer's instructions. Air will be gently applied to the cavity surface to create a shiny surface with an air gun. It will then be polymerised with an LED light device. Next, five different resin composites will be placed in the respective cavities and polymerised again with the light device. Finishing operations will be performed with a diamond-lobed milling cutter, and polishing operations will be performed with rubber systems. To evaluate the clinical success of the restorations, participants will be called at 1 week (baseline), 6 months, and 1 year to be evaluated by two specialists using FDI criteria and the results will be recorded.
- Conditions
- Dental Caries Class II
- Being tested
- Clearfil Majesty Posterior, Omnichroma Universal Group, Zen Universal Group, Vittra Aps Unique Universal Group, Charisma Diamond Universal Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearfil Majesty PosteriorOther
After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.
Omnichroma Universal GroupOther
After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.
Zen Universal GroupOther
After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.
Vittra Aps Unique Universal GroupOther
After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.
Charisma Diamond Universal GroupOther
After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.
| Study group | Role | What they receive |
|---|---|---|
| Clearfil Majesty Posterior | Placebo comparator | It is a type of composite used in the back group of teeth. It was used for the control group. Receives: Other: Clearfil Majesty Posterior |
| Omnichroma Universal Group | Experimental | It is a single-color universal resin composite used in both anterior and posterior group teeth. Receives: Other: Omnichroma Universal Group |
| Zen Universal Group | Experimental | It is a single-color universal resin composite used in both anterior and posterior group teeth. Receives: Other: Zen Universal Group |
| Vittra Aps Unique Universal Group | Experimental | It is a single-color universal resin composite used in both anterior and posterior group teeth. Receives: Other: Vittra Aps Unique Universal Group |
| Charisma Diamond Universal Group | Experimental | It is a single-color universal resin composite used in both anterior and posterior group teeth. Receives: Other: Charisma Diamond Universal Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group 1: Omnichroma (Tokuyama Dental) Universal Composite
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
Measured: Baseline, 6th month and 12th month
Group 2: Vittra APS Unique (FGM) Universal Composite
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
Measured: Baseline, 6th month and 12th month
Group 3: Zen Chroma (President Dental) Universal Composite
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
Measured: Baseline, 6th month and 12th month
Group 4: Charisma Diamond (Kulzer) Universal Composite
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
Measured: Baseline, 6th month and 12th month
Group 5: Clearfill Majesty Posterior (Kuraray) Dental Composite
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
Measured: Baseline, 6th month and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start19 Aug 2024
- Primary completion27 Aug 2025
- Study completion27 Nov 2025
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 Caries Class IIStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Five groups with a control goup
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Cadirci, Ataturk University
- Investigators
- Mustafa Çadırcı, Study director, Atatürk University Faculty of Dentistry Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563128
- Sponsor's protocol ID
- TDH-2023-13250
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cadirci M, Ozakar N. Clinical performance of single shade universal resin composites: a randomized controlled one year follow-up study. BMC Oral Health. 2025 Dec 18;26(1):154. doi: 10.1186/s12903-025-07472-3.
PubMed 41413535
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Success of Single Colour Universal Resin Composites
- ClinicalTrials.gov ID
- NCT06563128
- Acronym / sponsor ID
- TDH-2023-13250
- Conditions
- Dental Caries Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 20 Aug 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.
According to FDI criteria, the success of 4 different universal resin composites was targeted. In our study, a total of 180 teeth will be restored in class 2 cavities with 5 different composite resins in 5 groups.
Detailed description
The study will be conducted in the clinic of the Atatürk University Faculty of Dentistry, Department of Restorative Dental Treatment. After the participants fulfil the inclusion criteria, no interventional procedures other than the treatments routinely applied in the clinic will be performed. Participants who apply to the clinic with the need for dental caries treatment will be included in the study if they accept it. Before the treatment, anamnesis will be taken from the participants, and their information (age, gender) will be recorded. If necessary, local anaesthesia will be applied before or after opening the cavity. If anaesthesia is applied, they will be asked whether they feel numbness. In the study, a total of 180 teeth in 5 groups will be restored with 5 different composite resins.
Group 1: Omnichroma Group 2: Vittra Aps Unique Group 3: OneShade Group 4: Charisma Diamond Group 5: Clearfil Majesty Posterior
Then, the cavity will be prepared by using diamond rond and steel rond drills in class 2 cavity preparation. After the enamel surfaces of the teeth are roughened and washed with 37% orthophosphoric acid for 30 seconds, the necessary isolation will be provided with cotton pellets and saliva absorbent. Teeth will be fixed with matrix band and wedge systems. The adhesive bond system will be applied to all surfaces of the cavity with a bonding brush according to the manufacturer's instructions. Air will be gently applied to the cavity surface to create a shiny surface with an air gun. It will then be polymerised with an LED light device. Next, five different resin composites will be placed in the respective cavities and polymerised again with the light device. Finishing operations will be performed with a diamond-lobed milling cutter, and polishing operations will be performed with rubber systems. To evaluate the clinical success of the restorations, participants will be called at 1 week (baseline), 6 months, and 1 year to be evaluated by two specialists using FDI criteria and the results will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Five groups with a control goup
| Arm | Type | Receives |
|---|---|---|
| Clearfil Majesty Posterior | Placebo comparator | Other: Clearfil Majesty PosteriorIt is a type of composite used in the back group of teeth. It was used for the control group. |
| Omnichroma Universal Group | Experimental | Other: Omnichroma Universal GroupIt is a single-color universal resin composite used in both anterior and posterior group teeth. |
| Zen Universal Group | Experimental | Other: Zen Universal GroupIt is a single-color universal resin composite used in both anterior and posterior group teeth. |
| Vittra Aps Unique Universal Group | Experimental | Other: Vittra Aps Unique Universal GroupIt is a single-color universal resin composite used in both anterior and posterior group teeth. |
| Charisma Diamond Universal Group | Experimental | Other: Charisma Diamond Universal GroupIt is a single-color universal resin composite used in both anterior and posterior group teeth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient should not have any systemic disease.
- You must be 18 years of age or older.
- The patient must have good periodontal health.
- Must have acceptable oral hygiene.
- The teeth to be restored must be symptom-free and vital.
Key exclusion criteria (9 listed)
- The patient has any systemic disease.
- Previously adhered restoration and endodontic treatment on the tooth to be restored.
- Poor periodontal health of the patient.
- Poor oral hygiene.
- The patient is pregnant or breastfeeding.
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 |
|---|---|---|
| Clearfil Majesty PosteriorAfter filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded. | Other | Clearfil Majesty Posterior |
| Omnichroma Universal GroupAfter filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded. | Other | Omnichroma Universal Group |
| Zen Universal GroupAfter filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded. | Other | Zen Universal Group |
| Vittra Aps Unique Universal GroupAfter filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded. | Other | Vittra Aps Unique Universal Group |
| Charisma Diamond Universal GroupAfter filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded. | Other | Charisma Diamond Universal Group |
Primary outcome
Group 1: Omnichroma (Tokuyama Dental) Universal Composite
Time frame: Baseline, 6th month and 12th month
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
Group 2: Vittra APS Unique (FGM) Universal Composite
Time frame: Baseline, 6th month and 12th month
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
Group 3: Zen Chroma (President Dental) Universal Composite
Time frame: Baseline, 6th month and 12th month
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
Group 4: Charisma Diamond (Kulzer) Universal Composite
Time frame: Baseline, 6th month and 12th month
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
Group 5: Clearfill Majesty Posterior (Kuraray) Dental Composite
Time frame: Baseline, 6th month and 12th month
Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
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 28 Oct 2026.
- Derived from this study: PubMed 41413535Cadirci M, Ozakar N. Clinical performance of single shade universal resin composites: a randomized controlled one year follow-up study. BMC Oral Health. 2025 Dec 18;26(1):154. doi: 10.1186/s12903-025-07472-3.
- 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.
Mustafa Çadırcı study director
Atatürk University Faculty of Dentistry Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clearfil Majesty Posterior, Omnichroma Universal Group and Zen Universal Group in people with Dental Caries Class II, run by Ataturk 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 10 inclusion and 9 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 28 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
Group 1: Omnichroma (Tokuyama Dental) Universal Composite (time frame: Baseline, 6th month and 12th month). The study lists 5 primary outcomes in all. 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 NCT06563128, 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 28 Oct 2026.