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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • 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

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
Intervention / Treatment
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

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

Hacettepe University

Investigators

  • 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)

March 19, 2024

Primary Completion (Actual)

March 19, 2025

Study Completion (Estimated)

March 19, 2028

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID 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.

Clinical Trials on Cervical Lesion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe