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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of Three Different Universal Adhesives and a Universal Flowable Composite for Restoration of Non-carious Cervical Lesions

Conditions
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Tooth Diseases

Intervention / Treatment
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* Device: Clearfil Univesal Bond
* Device: IBond Universal
* Device: G-Premio Bond


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group CU (Clearfil Universal)<br>Clearfil Univesal Bond (Kuraray Dental, New York, United States of America), adhesive system | Device: Clearfil Univesal Bond<br>* Adhesive systems<br>|
| Experimental: Group IU (Ibond Universal)<br>IBond Universal (Heraeus Kulzer GmbH, Hanau, Germany), adhesive system | Device: IBond Universal<br>* Adhesive systems<br>|
| Experimental: Group GP (G-Premio)<br>G-Premio Bond (GC Coorporation, Tokyo, Japan), adhesive system | Device: G-Premio Bond<br>* Adhesive systems<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performances of different universal adhesives | Two year results according to USPHS criteria | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-caries cervical lesion, universal adhesives