Evaluating Universal Adhesives in Cervical Lesions

March 4, 2026 updated by: Cansu Atalay, Hacettepe University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: G2 Bond Universal
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).
Device: G2 Bond Universal, GC Europe N.V., Leuven, Belgium
G2 Bond Universal, GC Europe N.V., Leuven, Belgium
Experimental: Scotchbond Universal Plus
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).
Device: Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA
Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA
Experimental: Tokuyama Universal Bond II
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).
Device: Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan
Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From baseline to 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cansu Atalay, Assoc. Prof., Hacettepe University
  • Principal Investigator: Ayşe Rüya Yazıcı, Prof., Hacettepe University
  • Principal Investigator: Aybüke Uslu Tekce, Assist. Prof., Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA-23085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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