Cervical LesionNCT07459374
Evaluating Universal Adhesives in Cervical Lesions
A study testing G2 Bond Universal, GC Europe N.V., Leuven, Belgium, Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA and Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan in people with Cervical Lesion and Dental, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled clinical trial is to evaluate the 12-month clinical performance of restorations placed in NCCLs using universal adhesives with different compositions according to FDI criteria. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Lesion, Dental
- What is being tested?
- G2 Bond Universal, GC Europe N.V., Leuven, Belgium, Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA and Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2024to 19 Mar 2028
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals aged 18-55 years
- No systemic condition contraindicating restorative treatment
- Brushing teeth at least twice daily
- At least 20 teeth in occlusion
- At least three vital posterior teeth with non-carious cervical lesions and antagonist teeth
- Completed initial periodontal therapy
- Signed informed consent
Who cannot join
- Healthy individuals aged 18-55 years
- No systemic condition contraindicating restorative treatment
- Brushing teeth at least twice daily
- At least 20 teeth in occlusion
- At least three vital posterior teeth with non-carious cervical lesions and antagonist teeth
- Completed initial periodontal therapy
- Signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Performance of Universal Adhesives in Non-Carious Cervical Lesions: A Randomized Controlled Clinical Trial
The aim of this randomized controlled clinical trial is to evaluate the 12-month clinical performance of restorations placed in NCCLs using universal adhesives with different compositions according to FDI criteria.
Read the detailed description
This controlled, randomized, single-blind clinical trial will compare the clinical effectiveness of three universal adhesive systems with different compositions in the restoration of non-carious cervical lesions. A total of 30 healthy volunteers aged 18-55 years will be included. Each participant must present with at least three vital posterior teeth with non-carious cervical lesions (≥3 lesions), with both enamel and dentin involvement and with antagonist teeth in occlusion. Each participant will receive restorations using all three adhesive systems in different teeth (split- mouth design). Randomization will be performed using a computer-generated randomization table (Research Randomizer Program). An experienced operator from the Department of Restorative Dentistry will perform all restorative procedures (AUT). Radiographs will be taken at baseline (before treatment) and at 12-, 24- and 36-month follow-up appointments to assess adaptation, marginal integrity, and proximity to the pulp. Additional radiographs will only be taken if clinically indicated (e.g., suspected endodontic involvement). Restorations will be evaluated immediately after placement, at 12-, 24- and 36-month using FDI evaluation criteria.
- Conditions
- Cervical Lesion, Dental
- Being tested
- G2 Bond Universal, GC Europe N.V., Leuven, Belgium, Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA, Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan
- Keywords
- G2 Bond Universal, Scotchbond Universal Plus, Tokuyama Universal Bond II, Non-Carious Cervical Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G2 Bond Universal, GC Europe N.V., Leuven, BelgiumDevice
G2 Bond Universal, GC Europe N.V., Leuven, Belgium
Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USADevice
Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA
Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, JapanDevice
Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan
| Study group | Role | What they receive |
|---|---|---|
| G2 Bond Universal | Experimental | Enamel margins will be beveled (0.5 mm) using a flame-shaped diamond bur.Isolation will be achieved using cotton rolls and saliva ejector. Enamel surfaces will be etched with 35% phosphoric acid for 15 seconds, rinsed for 15 seconds, and dentin left slightly moist. Adhesives will be applied according to the manufacturer's instructions. A nanohybrid universal composite (OptiShade, Kerr Corporation, Orange, CA, USA) will be placed incrementally (≤2 mm layers) and light-cured. Finishing and polishing will be performed using OptiDisc discs and HiLuster polishing system (Kerr). Receives: Device: G2 Bond Universal, GC Europe N.V., Leuven, Belgium |
| Scotchbond Universal Plus | Experimental | Enamel margins will be beveled (0.5 mm) using a flame-shaped diamond bur. Isolation will be achieved using cotton rolls and saliva ejector. Enamel surfaces will be etched with 35% phosphoric acid for 15 seconds, rinsed for 15 seconds, and dentin left slightly moist. Adhesives will be applied according to the manufacturer's instructions. A nanohybrid universal composite (OptiShade, Kerr Corporation, Orange, CA, USA) will be placed incrementally (≤2 mm layers) and light-cured. Finishing and polishing will be performed using OptiDisc discs and HiLuster polishing system (Kerr). Receives: Device: Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA |
| Tokuyama Universal Bond II | Experimental | Enamel margins will be beveled (0.5 mm) using a flame-shaped diamond bur. Isolation will be achieved using cotton rolls and saliva ejector. Enamel surfaces will be etched with 35% phosphoric acid for 15 seconds, rinsed for 15 seconds, and dentin left slightly moist. Adhesives will be applied according to the manufacturer's instructions. A nanohybrid universal composite (OptiShade, Kerr Corporation, Orange, CA, USA) will be placed incrementally (≤2 mm layers) and light-cured. Finishing and polishing will be performed using OptiDisc discs and HiLuster polishing system (Kerr). Receives: Device: Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration survival rate at 12 months
Restoration survival rate at 12 months, defined as:
At least 90% of restorations remaining in situ No statistically significant difference among groups according to FDI criteria
Measured: From baseline to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start19 Mar 2024
- Primary completion19 Mar 2025
- Study completion19 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical LesionStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Atalay, Hacettepe University
- Investigators
- Cansu Atalay, Assoc. Prof., Principal investigator, Hacettepe UniversityAybüke Uslu Tekce, Assist. Prof., Principal investigator, Hacettepe UniversityAyşe Rüya Yazıcı, Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459374
- Sponsor's protocol ID
- KA-23085
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of Universal Adhesives in Non-Carious Cervical Lesions: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07459374
- Acronym / sponsor ID
- KA-23085
- Conditions
- Cervical Lesion, Dental
- Keywords
- G2 Bond Universal, Scotchbond Universal Plus, Tokuyama Universal Bond II, Non-Carious Cervical Lesions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2028 (estimated)
- First posted
- 9 Mar 2026 (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 clinical trial is to evaluate the 12-month clinical performance of restorations placed in NCCLs using universal adhesives with different compositions according to FDI criteria.
Detailed description
This controlled, randomized, single-blind clinical trial will compare the clinical effectiveness of three universal adhesive systems with different compositions in the restoration of non-carious cervical lesions. A total of 30 healthy volunteers aged 18-55 years will be included. Each participant must present with at least three vital posterior teeth with non-carious cervical lesions (≥3 lesions), with both enamel and dentin involvement and with antagonist teeth in occlusion. Each participant will receive restorations using all three adhesive systems in different teeth (split- mouth design). Randomization will be performed using a computer-generated randomization table (Research Randomizer Program). An experienced operator from the Department of Restorative Dentistry will perform all restorative procedures (AUT). Radiographs will be taken at baseline (before treatment) and at 12-, 24- and 36-month follow-up appointments to assess adaptation, marginal integrity, and proximity to the pulp. Additional radiographs will only be taken if clinically indicated (e.g., suspected endodontic involvement). Restorations will be evaluated immediately after placement, at 12-, 24- and 36-month using FDI evaluation criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G2 Bond Universal | Experimental | Device: G2 Bond Universal, GC Europe N.V., Leuven, BelgiumEnamel margins will be beveled (0.5 mm) using a flame-shaped diamond bur.Isolation will be achieved using cotton rolls and saliva ejector. Enamel surfaces will be etched with 35% phosphoric acid for 15 seconds, rinsed for 15 seconds, and dentin left slightly moist. Adhesives will be applied according to the manufacturer's instructions. A nanohybrid universal composite (OptiShade, Kerr Corporation, Orange, CA, USA) will be placed incrementally (≤2 mm layers) and light-cured. Finishing and polishing will be performed using OptiDisc discs and HiLuster polishing system (Kerr). |
| Scotchbond Universal Plus | Experimental | Device: Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USAEnamel margins will be beveled (0.5 mm) using a flame-shaped diamond bur. Isolation will be achieved using cotton rolls and saliva ejector. Enamel surfaces will be etched with 35% phosphoric acid for 15 seconds, rinsed for 15 seconds, and dentin left slightly moist. Adhesives will be applied according to the manufacturer's instructions. A nanohybrid universal composite (OptiShade, Kerr Corporation, Orange, CA, USA) will be placed incrementally (≤2 mm layers) and light-cured. Finishing and polishing will be performed using OptiDisc discs and HiLuster polishing system (Kerr). |
| Tokuyama Universal Bond II | Experimental | Device: Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, JapanEnamel margins will be beveled (0.5 mm) using a flame-shaped diamond bur. Isolation will be achieved using cotton rolls and saliva ejector. Enamel surfaces will be etched with 35% phosphoric acid for 15 seconds, rinsed for 15 seconds, and dentin left slightly moist. Adhesives will be applied according to the manufacturer's instructions. A nanohybrid universal composite (OptiShade, Kerr Corporation, Orange, CA, USA) will be placed incrementally (≤2 mm layers) and light-cured. Finishing and polishing will be performed using OptiDisc discs and HiLuster polishing system (Kerr). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy individuals aged 18-55 years
- No systemic condition contraindicating restorative treatment
- Brushing teeth at least twice daily
- At least 20 teeth in occlusion
- At least three vital posterior teeth with non-carious cervical lesions and antagonist teeth
Key exclusion criteria (7 listed)
- Healthy individuals aged 18-55 years
- No systemic condition contraindicating restorative treatment
- Brushing teeth at least twice daily
- At least 20 teeth in occlusion
- At least three vital posterior teeth with non-carious cervical lesions and antagonist teeth
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 |
|---|---|---|
| G2 Bond Universal, GC Europe N.V., Leuven, BelgiumG2 Bond Universal, GC Europe N.V., Leuven, Belgium | Device | G2 Bond Universal |
| Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USAScotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA | Device | Scotchbond Universal Plus |
| Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, JapanTokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan | Device | Tokuyama Universal Bond II |
Primary outcome
Restoration survival rate at 12 months
Time frame: From baseline to 12 month
Restoration survival rate at 12 months, defined as: At least 90% of restorations remaining in situ No statistically significant difference among groups according to FDI 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 9 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Cansu Atalay, Assoc. Prof. principal investigator
Hacettepe University
Aybüke Uslu Tekce, Assist. Prof. principal investigator
Hacettepe University
Ayşe Rüya Yazıcı, Prof. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G2 Bond Universal, GC Europe N.V., Leuven, Belgium, Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA and Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan in people with Cervical Lesion and Dental, 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 7 inclusion and 7 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 9 Mar 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. 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?
Restoration survival rate at 12 months (time frame: From baseline to 12 month). 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 9 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.