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

NCT03415412 | Active Not Recruiting

• 1 other identifier: NCCLsclinic
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tooth Diseases

Keywords

non-caries cervical lesion; universal adhesives

Outcome Measures

Primary Outcomes (1)

• Clinical performances of different universal adhesives

  Two year results according to USPHS criteria

  Two years

Study Arms (3)

Group CU (Clearfil Universal)

EXPERIMENTAL

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

Device: Clearfil Univesal Bond

Group IU (Ibond Universal)

EXPERIMENTAL

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

Device: IBond Universal

Group GP (G-Premio)

EXPERIMENTAL

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

Device: G-Premio Bond

Interventions

Clearfil Univesal Bond DEVICE

Adhesive systems

Group CU (Clearfil Universal)

IBond Universal DEVICE

Adhesive systems

Group IU (Ibond Universal)

G-Premio Bond DEVICE

Adhesive systems

Group GP (G-Premio)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (1)

• 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.

  PMID: 35477817 DERIVED

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2017
• First Posted: January 30, 2018
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09