Tooth DiseasesNCT06375837
Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites
A study testing an alkasite-based restorative material, hybrid resin composite and a highly filled flowable resin composite in people with Tooth Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Diseases
- What is being tested?
- an alkasite-based restorative material, hybrid resin composite and a highly filled flowable resin composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 15 Jun 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
- Age range will be 18 to 65.
- They will be required to have at least three NCCLs needed restoration in different teeth.
- All the NCCLs selected will be in similar sizes.
Who cannot join
- Patients with severe periodontal disease
- Patients with rampant, uncontrolled caries
- Patients with xerostomia
- Patients with serious medical problems preventing them from attending review visits
- Patients with poor gingival health
- Patients with heavy bruxism
- Patients with removable partial dentures
- Patients undergoing bleaching treatment or orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites in Non-carious Cervical Lesions
The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests.
- Conditions
- Tooth Diseases
- Being tested
- an alkasite-based restorative material, hybrid resin composite, a highly filled flowable resin composite
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an alkasite-based restorative materialDevice
Cention N
hybrid resin compositeDevice
Gradia Direct Anterior
a highly filled flowable resin compositeDevice
G-aenial Universal Flo
| Study group | Role | What they receive |
|---|---|---|
| an alkasite-based restorative material | Experimental | Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN) The liquid and powder will be mixed and then applied according to manufacturer's instructions. Receives: Device: an alkasite-based restorative material |
| hybrid resin composite | Experimental | Gradia Direct Anterior, GC, Tokyo, Japan (GR) After applying 37% orthophosphoric acid to the enamel of the lesions for 30 seconds and to the dentin for 15 seconds, the acid will be washed with water and then dried with light air. A universal adhesive (G-Premio Bond, GC, Tokyo, Japan) and then the composite will be applied according to the manufacturer's instructions. Receives: Device: hybrid resin composite |
| a highly filled flowable resin composite | Experimental | G-aenial Universal Flo, GC, Tokyo, Japan (GF) After applying 37% orthophosphoric acid to the enamel of the lesions for 30 seconds and to the dentin for 15 seconds, the acid will be washed with water and then dried with light air. A universal adhesive (G-Premio Bond, GC, Tokyo, Japan) and then the composite will be applied according to the manufacturer's instructions. Receives: Device: a highly filled flowable resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)
Two year results according to FDI criteria. (Esthetic properties) The evaluations will be carried out using FDI criteria. Esthetic properties will be examined. Five scores will be given for each restoration: (1) Clinically excellent / very good, (2) Clinically good, (3) Clinically sufficient/satisfactory, (4) Clinically unsatisfactory, (5) Clinically poor.The data obtained for groups will be compared at each visit.
Measured: two years
Secondary outcomes (1)
Clinical performances of different restorative systems according to FDI criteria (Functional properties)
Two year results according to FDI criteria. (Functional properties) The evaluations will be carried out using FDI criteria. Functional properties will be examined.Five scores will be given for each restoration: (1) Clinically excellent / very good, (2) Clinically good, (3) Clinically sufficient/satisfactory, (4) Clinically unsatisfactory, (5) Clinically poor.The data obtained for groups will be compared at each visit.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start15 Apr 2024
- Primary completion15 Jun 2024
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseasesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fatma Dilşad Öz, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375837
- Sponsor's protocol ID
- bioactive-NCCLs
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2023
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites in Non-carious Cervical Lesions
- ClinicalTrials.gov ID
- NCT06375837
- Acronym / sponsor ID
- bioactive-NCCLs
- Conditions
- Tooth Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 19 Apr 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 clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| an alkasite-based restorative material | Experimental | Device: an alkasite-based restorative materialCention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN) The liquid and powder will be mixed and then applied according to manufacturer's instructions. |
| hybrid resin composite | Experimental | Device: hybrid resin compositeGradia Direct Anterior, GC, Tokyo, Japan (GR) After applying 37% orthophosphoric acid to the enamel of the lesions for 30 seconds and to the dentin for 15 seconds, the acid will be washed with water and then dried with light air. A universal adhesive (G-Premio Bond, GC, Tokyo, Japan) and then the composite will be applied according to the manufacturer's instructions. |
| a highly filled flowable resin composite | Experimental | Device: a highly filled flowable resin compositeG-aenial Universal Flo, GC, Tokyo, Japan (GF) After applying 37% orthophosphoric acid to the enamel of the lesions for 30 seconds and to the dentin for 15 seconds, the acid will be washed with water and then dried with light air. A universal adhesive (G-Premio Bond, GC, Tokyo, Japan) and then the composite will be applied according to the manufacturer's instructions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age range will be 18 to 65.
- They will be required to have at least three NCCLs needed restoration in different teeth.
- All the NCCLs selected will be in similar sizes.
Key exclusion criteria (8 listed)
- Patients with severe periodontal disease
- Patients with rampant, uncontrolled caries
- Patients with xerostomia
- Patients with serious medical problems preventing them from attending review visits
- Patients with poor gingival health
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 |
|---|---|---|
| an alkasite-based restorative materialCention N | Device | an alkasite-based restorative material |
| hybrid resin compositeGradia Direct Anterior | Device | hybrid resin composite |
| a highly filled flowable resin compositeG-aenial Universal Flo | Device | a highly filled flowable resin composite |
Primary outcome
Clinical performances of different restorative systems according to FDI criteria (Esthetic properties)
Time frame: two years
Two year results according to FDI criteria. (Esthetic properties) The evaluations will be carried out using FDI criteria. Esthetic properties will be examined. Five scores will be given for each restoration: (1) Clinically excellent / very good, (2) Clinically good, (3) Clinically sufficient/satisfactory, (4) Clinically unsatisfactory, (5) Clinically poor.The data obtained for groups will be compared at each visit.
1 secondary outcome
Clinical performances of different restorative systems according to FDI criteria (Functional properties)
Time frame: two 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 3 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an alkasite-based restorative material, hybrid resin composite and a highly filled flowable resin composite in people with Tooth Diseases, run by Hacettepe 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 8 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 3 Dec 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 performances of different restorative systems according to FDI criteria (Esthetic properties) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025.