NCT07459374

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Mar 2024Mar 2028

Study Start

First participant enrolled

March 19, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2028

Expected
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

G2 Bond UniversalScotchbond Universal PlusTokuyama Universal Bond IINon-Carious Cervical Lesions

Outcome Measures

Primary Outcomes (1)

  • 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

    From baseline to 12 month

Study Arms (3)

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).

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).

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).

Device: Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan

Interventions

G2 Bond Universal, GC Europe N.V., Leuven, Belgium

G2 Bond Universal

Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA

Scotchbond Universal Plus

Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan

Tokuyama Universal Bond II

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Study Officials

  • Cansu Atalay, Assoc. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Aybüke Uslu Tekce, Assist. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Ayşe Rüya Yazıcı, Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Assoc. Prof

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

March 19, 2024

Primary Completion

March 19, 2025

Study Completion (Estimated)

March 19, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations