Tooth DiseasesNCT03415412
Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions
A study testing Clearfil Univesal Bond, IBond Universal and G-Premio Bond in people with Tooth Diseases, run by Hacettepe University.
Trial summary
The aim of this randomized, controlled prospective clinical trial is to evaluate and compare the performances of three different universal adhesives using a flowable universal composite resin in the restoration of non-caries cervical lesions over 48-month period.Participants over 18 will be included to the study. 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?
- Clearfil Univesal Bond, IBond Universal and G-Premio Bond
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 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
- 18 years old with 20 teeth under occlusion. They will be required to have at least three NCCLs needed restoration in different teeth. All the NCCLs selected were in similar sizes varying between 1-3 mm.
Who cannot join
- Patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. Also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.
About this study
Official title: Clinical Evaluation of Three Different Universal Adhesives and a Universal Flowable Composite for Restoration of Non-carious Cervical Lesions
The aim of this randomized, controlled prospective clinical trial is to evaluate and compare the performances of three different universal adhesives using a flowable universal composite resin in the restoration of non-caries cervical lesions over 48-month period.Participants over 18 will be included to the study. Oral hygiene instructions will be given before procedures. All the lesions will be restored by the same clinician who will not participate to the selection of patients for eligibility. Each patient will receive at least three restorations and randomization will be applied using a table of random numbers. All lesions will be cleaned before restoring. Adhesive procedures and restorations will be placed according to manufacturers' recommandation.
The flowable universal composite resin will be placed in bulk and light-cured for 40 seconds. The restorations will be contoured and polished with Optidisc discs (Kerr Coorporation, Orange, CA, USA).
Patients will be recalled at baseline and will be recalled at control periods after placement.
- Conditions
- Tooth Diseases
- Being tested
- Clearfil Univesal Bond, IBond Universal, G-Premio Bond
- Keywords
- non-caries cervical lesion, universal adhesives
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearfil Univesal BondDevice
Adhesive systems
IBond UniversalDevice
Adhesive systems
G-Premio BondDevice
Adhesive systems
| Study group | Role | What they receive |
|---|---|---|
| Group CU (Clearfil Universal) | Experimental | Clearfil Univesal Bond (Kuraray Dental, New York, United States of America), adhesive system Receives: Device: Clearfil Univesal Bond |
| Group IU (Ibond Universal) | Experimental | IBond Universal (Heraeus Kulzer GmbH, Hanau, Germany), adhesive system Receives: Device: IBond Universal |
| Group GP (G-Premio) | Experimental | G-Premio Bond (GC Coorporation, Tokyo, Japan), adhesive system Receives: Device: G-Premio Bond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performances of different universal adhesives
Two year results according to USPHS criteria
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 posted30 Jan 2018
- Study start1 Apr 2016
- Primary completion1 Jun 2016
- Study completion1 Jun 2026 (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 Tooth DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 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
- NCT03415412
- Sponsor's protocol ID
- NCCLsclinic
- Status last verified
- Sep 2025
- First submitted
- 23 Dec 2017
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oz FD, Ozturk C, Soleimani R, Gurgan S. Sixty-month follow up of three different universal adhesives used with a highly-filled flowable resin composite in the restoration of non-carious cervical lesion. Clin Oral Investig. 2022 Aug;26(8):5377-5387. doi: 10.1007/s00784-022-04505-x. Epub 2022 Apr 27.
PubMed 35477817
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Three Different Universal Adhesives and a Universal Flowable Composite for Restoration of Non-carious Cervical Lesions
- ClinicalTrials.gov ID
- NCT03415412
- Acronym / sponsor ID
- NCCLsclinic
- Conditions
- Tooth Diseases
- Keywords
- non-caries cervical lesion, universal adhesives
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 Jan 2018 (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 randomized, controlled prospective clinical trial is to evaluate and compare the performances of three different universal adhesives using a flowable universal composite resin in the restoration of non-caries cervical lesions over 48-month period.Participants over 18 will be included to the study. Oral hygiene instructions will be given before procedures. All the lesions will be restored by the same clinician who will not participate to the selection of patients for eligibility. Each patient will receive at least three restorations and randomization will be applied using a table of random numbers. All lesions will be cleaned before restoring. Adhesive procedures and restorations will be placed according to manufacturers' recommandation.
The flowable universal composite resin will be placed in bulk and light-cured for 40 seconds. The restorations will be contoured and polished with Optidisc discs (Kerr Coorporation, Orange, CA, USA).
Patients will be recalled at baseline and will be recalled at control periods after placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group CU (Clearfil Universal) | Experimental | Device: Clearfil Univesal BondClearfil Univesal Bond (Kuraray Dental, New York, United States of America), adhesive system |
| Group IU (Ibond Universal) | Experimental | Device: IBond UniversalIBond Universal (Heraeus Kulzer GmbH, Hanau, Germany), adhesive system |
| Group GP (G-Premio) | Experimental | Device: G-Premio BondG-Premio Bond (GC Coorporation, Tokyo, Japan), adhesive system |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years old with 20 teeth under occlusion. They will be required to have at least three NCCLs needed restoration in different teeth. All the NCCLs selected were in similar sizes varying between 1-3 mm.
Key exclusion criteria (1 listed)
- Patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. Also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.
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 Univesal BondAdhesive systems | Device | Group CU (Clearfil Universal) |
| IBond UniversalAdhesive systems | Device | Group IU (Ibond Universal) |
| G-Premio BondAdhesive systems | Device | Group GP (G-Premio) |
Primary outcome
Clinical performances of different universal adhesives
Time frame: Two years
Two year results according to USPHS criteria
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 29 Sep 2025.
- Derived from this study: PubMed 35477817Oz FD, Ozturk C, Soleimani R, Gurgan S. Sixty-month follow up of three different universal adhesives used with a highly-filled flowable resin composite in the restoration of non-carious cervical lesion. Clin Oral Investig. 2022 Aug;26(8):5377-5387. doi: 10.1007/s00784-022-04505-x. Epub 2022 Apr 27.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Clearfil Univesal Bond, IBond Universal and G-Premio Bond in people with Tooth Diseases, run by Hacettepe 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 1 inclusion and 1 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 29 Sep 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?
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 universal adhesives (time frame: Two 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 NCT03415412, 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 29 Sep 2025.