Dental CariesNCT07289022
Clinical Evaluation of Flowable Monochromatic and Polychromatic Composite Resins in Posterior Restorations
A study testing dental composite in people with Dental Caries, run by Istanbul University.
Trial summary
This clinical study aims to investigate whether a single flowable composite resin system can achieve adequate color matching in posterior restorations and to compare it with a polychromatic composite system, which will serve as a control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries
- What is being tested?
- dental composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2026to 5 Apr 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be over 18 years of age and have no systemic disease.
- Participants must have acceptable oral hygiene and at least 20 teeth in occlusion.
- Participants must have at least four Class I-II carious lesions requiring treatment.
- Lesions must involve both enamel and dentin, and the involved teeth must be vital and non-mobile.
- All participants must read and sign an informed consent form prior to enrollment.
Who cannot join
- Presence of any general health problem (systemic disease).
- Periodontal disease or poor oral hygiene.
- Tooth mobility or non-vital teeth in the target teeth.
- Bruxism or uncontrolled parafunction
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Color Matching Ability and Clinical Success of Flowable Monochromatic and Polychromatic Composite Resins in Posterior Restorations
This clinical study aims to investigate whether a single flowable composite resin system can achieve adequate color matching in posterior restorations and to compare it with a polychromatic composite system, which will serve as a control group. Clinical success will also be assessed using data obtained from the initial, six month, one-year, two-year, three-year, four-year, and five-year recall checks of the four different composite resin systems used in the study over a five-year period. L, a, and b parameters will be determined using the Vita Easyshade Compact (VITA Zahnfabrik, Bad Sackingen, Germany) Spectrophotometer device used in the study at the initial, half-year, one-year, two-year, three-year, four-year, and five-year intervals. Based on the obtained data, intraoral color changes will be determined using the CIEDE2000 color system. Each patient will be scanned with an intraoral scanner at each session. The hypothesis tested was that color matching and long-term clinical follow-up would be successful for all composite materials used in the study.
- Conditions
- Dental Caries
- Being tested
- dental composite
- Keywords
- dental composite resin, dental caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental compositeDevice
Overview: Four composite resin systems will be evaluated in posterior Class II restorations for color matching ability and clinical performance over 5 years. A polychromatic composite serves as the control; three single-shade/flowable or bulk-fill composites constitute the intervention arms.
Isolation and preparation: All restorations will be performed under rubber dam using standardized cavity preparation and finishing/polishing protocols.
Adhesive and etching: A single adhesive approach will be used across arms per manufacturer's instructions (self etch).
Placement:
Control (polychromatic): Layered placement per manufacturer. Single-shade/flowable/bulk-fill arms: Incremental or bulk placement within 2-5 mm as recommended.
Light curing: Light-emitting diode (LED) light-curing units at 1200 mW/cm² for 20 s per increment; distance and angulation standardized.
Assessment and follow-up: Baseline, 6 months, and annually up to 5 years. Color measured with Vita Easyshade
| Study group | Role | What they receive |
|---|---|---|
| Three posterior caries lesions will be separated into three monochromatic dental composite groups | Other | Treatment of posterior caries lesions. Three of the carious lesions in the posterior four caries teeth will be separated into three groups according to material strategies described below: 1-monochromatic bulk without pigment flowable composite Omnichroma Flow Bulk (tokuyama dental) , 2-monochromatic bulk flowable composite Charisma Bulk Flow One (Kulzer), 3- monochromatic flowable composite Clearfil Majesty™ ES flow-low (Kuraray), Receives: Device: dental composite |
| One posterior caries lesion will be separated into one polychromatic dental flowable composite | Other | Treatment of posterior caries lesion. One of the carious lesions in the posterior four caries teeth will be separated according to the material strategies used for Grandio SO flowable polychromatic dental composite (Voco) as a control group Receives: Device: dental composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical acceptability of restorations according to FDI criteria
Restorations will be evaluated by a blinded assessor using the World Dental Federation (FDI) criteria across functional, esthetic, and biological domains. Clinical acceptability is defined as FDI scores 1-3. The primary analysis will report the proportion of clinically acceptable restorations and the trajectory of scores over time.
Measured: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary outcomes (1)
Color difference (ΔE00) using the CIEDE2000 system
objective color measurements will be obtained with a spectrophotometer (Vita Easyshade Compact, VITA Zahnfabrik, Bad Säckingen, Germany). L*, a*, b* values will be recorded on the restoration and adjacent tooth surfaces at each follow-up. Color difference will be calculated using the CIEDE2000 formula (ΔE00). Clinical acceptability will be defined by a predefined threshold (e.g., ΔE00 ≤ 1.8), and both mean ΔE00 and the proportion of clinically acceptable cases will be reported.
Measured: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start5 Jan 2026 (estimated)
- Primary completion5 May 2026 (estimated)
- Study completion5 Apr 2031 (estimated)
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 CariesStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- split-mouth
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Tuncer, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289022
- Sponsor's protocol ID
- 2025-038
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to patient confidentiality and institutional/data protection policies; aggregated results will be available in publications.
Publications
Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.
PubMed 36504246
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Color Matching Ability and Clinical Success of Flowable Monochromatic and Polychromatic Composite Resins in Posterior Restorations
- ClinicalTrials.gov ID
- NCT07289022
- Acronym / sponsor ID
- 2025-038
- Conditions
- Dental Caries
- Keywords
- dental composite resin, dental caries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 Apr 2031 (estimated)
- First posted
- 17 Dec 2025 (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.
This clinical study aims to investigate whether a single flowable composite resin system can achieve adequate color matching in posterior restorations and to compare it with a polychromatic composite system, which will serve as a control group. Clinical success will also be assessed using data obtained from the initial, six month, one-year, two-year, three-year, four-year, and five-year recall checks of the four different composite resin systems used in the study over a five-year period. L, a, and b parameters will be determined using the Vita Easyshade Compact (VITA Zahnfabrik, Bad Sackingen, Germany) Spectrophotometer device used in the study at the initial, half-year, one-year, two-year, three-year, four-year, and five-year intervals. Based on the obtained data, intraoral color changes will be determined using the CIEDE2000 color system. Each patient will be scanned with an intraoral scanner at each session. The hypothesis tested was that color matching and long-term clinical follow-up would be successful for all composite materials used in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth
| Arm | Type | Receives |
|---|---|---|
| Three posterior caries lesions will be separated into three monochromatic dental composite groups | Other | Device: dental compositeTreatment of posterior caries lesions. Three of the carious lesions in the posterior four caries teeth will be separated into three groups according to material strategies described below: 1-monochromatic bulk without pigment flowable composite Omnichroma Flow Bulk (tokuyama dental) , 2-monochromatic bulk flowable composite Charisma Bulk Flow One (Kulzer), 3- monochromatic flowable composite Clearfil Majesty™ ES flow-low (Kuraray), |
| One posterior caries lesion will be separated into one polychromatic dental flowable composite | Other | Device: dental compositeTreatment of posterior caries lesion. One of the carious lesions in the posterior four caries teeth will be separated according to the material strategies used for Grandio SO flowable polychromatic dental composite (Voco) as a control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be over 18 years of age and have no systemic disease.
- Participants must have acceptable oral hygiene and at least 20 teeth in occlusion.
- Participants must have at least four Class I-II carious lesions requiring treatment.
- Lesions must involve both enamel and dentin, and the involved teeth must be vital and non-mobile.
- All participants must read and sign an informed consent form prior to enrollment.
Key exclusion criteria (4 listed)
- Presence of any general health problem (systemic disease).
- Periodontal disease or poor oral hygiene.
- Tooth mobility or non-vital teeth in the target teeth.
- Bruxism or uncontrolled parafunction
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 |
|---|---|---|
| dental compositeOverview: Four composite resin systems will be evaluated in posterior Class II restorations for color matching ability and clinical performance over 5 years. A polychromatic composite serves as the control; three single-shade/flowable or bulk-fill composites constitute the intervention arms. Isolation and preparation: All restorations will be performed under rubber dam using standardized cavity preparation and finishing/polishing protocols. Adhesive and etching: A single adhesive approach will be used across arms per manufacturer's instructions (self etch). Placement: Control (polychromatic): Layered placement per manufacturer. Single-shade/flowable/bulk-fill arms: Incremental or bulk placement within 2-5 mm as recommended. Light curing: Light-emitting diode (LED) light-curing units at 1200 mW/cm² for 20 s per increment; distance and angulation standardized. Assessment and follow-up: Baseline, 6 months, and annually up to 5 years. Color measured with Vita Easyshade | Device | One posterior caries lesion will be separated into one polychromatic dental flowable composite, Three posterior caries lesions will be separated into three monochromatic dental composite groups |
Primary outcome
Clinical acceptability of restorations according to FDI criteria
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Restorations will be evaluated by a blinded assessor using the World Dental Federation (FDI) criteria across functional, esthetic, and biological domains. Clinical acceptability is defined as FDI scores 1-3. The primary analysis will report the proportion of clinically acceptable restorations and the trajectory of scores over time.
1 secondary outcome
Color difference (ΔE00) using the CIEDE2000 system
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
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 17 Dec 2025.
- Background: PubMed 36504246Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.
- Individual participant dataSharing planned: No. IPD will not be shared due to patient confidentiality and institutional/data protection policies; aggregated results will be available in publications.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Questions about this trial
What is this clinical trial studying?
A study testing dental composite in people with Dental Caries, run by Istanbul University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact safa tuncer, Phd DDs (+905336342450, tuncers@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical acceptability of restorations according to FDI criteria (time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years). 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 NCT07289022, 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 17 Dec 2025.