Tooth WearNCT04481087
Clinical Comparison of Different Adhesives in NCCLs
A study testing Clearfil Universal Bond Quick, Clearfil SE Bond and Tetric N-Bond in people with Tooth Wear, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of a universal adhesive in three different application modes, a self-etch adhesive and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Thirty-four patients will receive restorations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- Clearfil Universal Bond Quick, Clearfil SE Bond and Tetric N-Bond
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2018to 10 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
- being 18 years or older,
- having no medical or behavioral problems preventing then from attending review visits,
- having at least 5 tooth with NCCLs
- having antagonist teeth
Who cannot join
- poor gingival health,
- uncontrolled, rampant caries,
- bruxism,
- removable partial dentures,
- xerostomia
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of a universal adhesive in three different application modes, a self-etch adhesive and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Thirty-four patients will receive restorations. Lesions will be divided into 5 groups according to adhesive systems and application modes: CU-SE: Clearfil Universal Bond Quick in self-etch mode, CU-SLE: Clearfil Universal Bond Quick in selective etch mode, CU-ER: Clearfil Universal Bond Quick in etch\&rinse mode, CSE: Clearfil SE Bond, TB: Tetric N-Bond. Restorations (Tetric N-Ceram composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. Descriptive statistics will be performed using Chi-square tests.
- Conditions
- Tooth Wear
- Being tested
- Clearfil Universal Bond Quick, Clearfil SE Bond, Tetric N-Bond
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearfil Universal Bond QuickDevice
Adhesive systems
Clearfil Universal Bond QuickDevice
Adhesive systems
Clearfil Universal Bond QuickDevice
Adhesive systems
Clearfil SE BondDevice
Adhesive systems
Tetric N-BondDevice
Adhesive systems
| Study group | Role | What they receive |
|---|---|---|
| Clearfil Universal Bond Quick, self-etch mode (CU-SE) | Experimental | Not described Receives: Device: Clearfil Universal Bond Quick |
| Clearfil Universal Bond Quick, selective etch mode (CU-SLE) | Experimental | Not described Receives: Device: Clearfil Universal Bond Quick |
| Clearfil Universal Bond Quick, etch&rinse mode (CU-ER) | Experimental | Not described Receives: Device: Clearfil Universal Bond Quick |
| Clearfil SE Bond (CSE) | Experimental | Not described Receives: Device: Clearfil SE Bond |
| Tetric N-Bond (TB) | Experimental | Not described Receives: Device: Tetric N-Bond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performances of different adhesives
Two year examinations 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 posted22 Jul 2020
- Study start10 Feb 2018
- Primary completion10 May 2018
- Study completion10 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 WearStudies 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
- 34 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
- NCT04481087
- Sponsor's protocol ID
- NCCLs universal
- Status last verified
- Sep 2025
- First submitted
- 17 Jul 2020
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Comparison of Different Adhesives in NCCLs
- ClinicalTrials.gov ID
- NCT04481087
- Acronym / sponsor ID
- NCCLs universal
- Conditions
- Tooth Wear
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 22 Jul 2020 (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 the performances of a universal adhesive in three different application modes, a self-etch adhesive and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Thirty-four patients will receive restorations. Lesions will be divided into 5 groups according to adhesive systems and application modes: CU-SE: Clearfil Universal Bond Quick in self-etch mode, CU-SLE: Clearfil Universal Bond Quick in selective etch mode, CU-ER: Clearfil Universal Bond Quick in etch\&rinse mode, CSE: Clearfil SE Bond, TB: Tetric N-Bond. Restorations (Tetric N-Ceram composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. 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
- 5
| Arm | Type | Receives |
|---|---|---|
| Clearfil Universal Bond Quick, self-etch mode (CU-SE) | Experimental | Device: Clearfil Universal Bond Quick |
| Clearfil Universal Bond Quick, selective etch mode (CU-SLE) | Experimental | Device: Clearfil Universal Bond Quick |
| Clearfil Universal Bond Quick, etch&rinse mode (CU-ER) | Experimental | Device: Clearfil Universal Bond Quick |
| Clearfil SE Bond (CSE) | Experimental | Device: Clearfil SE Bond |
| Tetric N-Bond (TB) | Experimental | Device: Tetric N-Bond |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being 18 years or older,
- having no medical or behavioral problems preventing then from attending review visits,
- having at least 5 tooth with NCCLs
- having antagonist teeth
Key exclusion criteria (5 listed)
- poor gingival health,
- uncontrolled, rampant caries,
- bruxism,
- removable partial dentures,
- xerostomia
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 Universal Bond QuickAdhesive systems | Device | Clearfil Universal Bond Quick, self-etch mode (CU-SE) |
| Clearfil Universal Bond QuickAdhesive systems | Device | Clearfil Universal Bond Quick, selective etch mode (CU-SLE) |
| Clearfil Universal Bond QuickAdhesive systems | Device | Clearfil Universal Bond Quick, etch&rinse mode (CU-ER) |
| Clearfil SE BondAdhesive systems | Device | Clearfil SE Bond (CSE) |
| Tetric N-BondAdhesive systems | Device | Tetric N-Bond (TB) |
Primary outcome
Clinical performances of different adhesives
Time frame: two years
Two year examinations 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.
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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 Clearfil Universal Bond Quick, Clearfil SE Bond and Tetric N-Bond in people with Tooth Wear, 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 4 inclusion and 5 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.
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 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?
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.