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Active, not recruitingNCT03415412Updated Sep 29, 2025

Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions

An interventional study of Clearfil Univesal Bond and IBond Universal in Tooth Diseases, sponsored by Hacettepe University. Active, not recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this randomized, controlled prospective clinical trial is to evaluate and compare the performances of three different universal adhesives using a flowable universal composite resin in the restoration of non-caries cervical lesions over 48-month period.Participants over 18 will be included to the study. Oral hygiene instructions will be given before procedures. All the lesions will be restored by the same clinician who will not participate to the selection of patients for eligibility. Each patient will receive at least three restorations and randomization will be applied using a table of random numbers. All lesions will be cleaned before restoring. Adhesive procedures and restorations will be placed according to manufacturers' recommandation.

The flowable universal composite resin will be placed in bulk and light-cured for 40 seconds. The restorations will be contoured and polished with Optidisc discs (Kerr Coorporation, Orange, CA, USA).

Patients will be recalled at baseline and will be recalled at control periods after placement.

02

Conditions studied

  • Tooth Diseases

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Keywords

  • non-caries cervical lesion
  • universal adhesives
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 years old with 20 teeth under occlusion. They will be required to have at least three NCCLs needed restoration in different teeth. All the NCCLs selected were in similar sizes varying between 1-3 mm.

Exclusion criteria

Exclusion Criteria:

  • Patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. Also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Group CU (Clearfil Universal)

    Clearfil Univesal Bond (Kuraray Dental, New York, United States of America), adhesive system

    Device: Clearfil Univesal Bond

  • Experimental
    Group IU (Ibond Universal)

    IBond Universal (Heraeus Kulzer GmbH, Hanau, Germany), adhesive system

    Device: IBond Universal

  • Experimental
    Group GP (G-Premio)

    G-Premio Bond (GC Coorporation, Tokyo, Japan), adhesive system

    Device: G-Premio Bond

Interventions

  • DeviceClearfil Univesal Bond

    Adhesive systems

  • DeviceIBond Universal

    Adhesive systems

  • DeviceG-Premio Bond

    Adhesive systems

05

What researchers measure

Primary outcomes

  1. Clinical performances of different universal adhesives

    Two year results according to USPHS criteria

    Time frame: Two years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Oz FD, Ozturk C, Soleimani R, Gurgan S. Sixty-month follow up of three different universal adhesives used with a highly-filled flowable resin composite in the restoration of non-carious cervical lesion. Clin Oral Investig. 2022 Aug;26(8):5377-5387. doi: 10.1007/s00784-022-04505-x. Epub 2022 Apr 27. PubMed 35477817 ↗
08

Registry details

Key details

Study ID
NCT03415412
Lead sponsor
Hacettepe University
Responsible party
Dr. Fatma Dilşad Öz (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Jan 30, 2018
Start date
Apr 1, 2016
Primary completion
Jun 1, 2016
Completion
Jun 1, 2026 (estimated)
Last update
Sep 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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