Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions

Study Overview
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Brief Summary
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The objective of this randomized, double-blind clinical trial is to evaluate the clinical performance of non-carious cervicals adhesive restorations using three self-etching adhesives containing HEMA and 10-MDP monomers.

Detailed Description
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Sixty teeth (n = 20 for each group) will be randomized into 03 groups: Clearfil SE (contains MDP and HEMA), Optibond All-inOne (contains HEMA) and Prime and Bond Universal (contains neither monomer) dispatch). Restorations will be performed by a single operator, and no mechanical retention will be performed under the cavity. After 6, 12 and 24 months, the restorations will be evaluated by two calibrated examiners, using modified USPHS criteria for retention (kappa = 1.00) and adaptation / marginal color (kappa = 0.81), and the results will be analysed by Fisher and Kruskal-Wallis, respectively. An intragroup analysis will be performed using the Cochran test (for retention) and Wilcoxon (for marginal adaptation / staining).

Official Title
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Clinical Performance of Adhesive Systems Containing HEMA and 10-MDP in Non Carious Cervical Lesions - A Two Years Randomized Double Blind Study

Conditions
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Non Carious Cervical Lesion

Intervention / Treatment
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* Other: composite resin restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good oral hygiene Absence of periodontal disease Presence of at least 02 non-carious cervical lesions Exclusion Criteria: Presence of non-carious cervical lesion in non-vital teeth Occlusal instability Presence of orthodontic appliance Presence of removable partial dental prosthesis High risk of caries (presence of three or more active caries lesions) Xerostomia Bruxism Patients allergic to base materials monomers Patients who do not accept the project conditions

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clearfil SE<br>Group containing 10-MDP and HEMA monomers | Other: composite resin restoration<br>* All patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime & Bond Universal.<br>* Other names: composite resin restorations with Prime & Bond Universal adhesive;|
| Active Comparator: Optibond All-in-One<br>Group containing HEMA monomer | Other: composite resin restoration<br>* All patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime & Bond Universal.<br>* Other names: composite resin restorations with Prime & Bond Universal adhesive;|
| Active Comparator: Prime & Bond Universal<br>Control Group containing other monomers | Other: composite resin restoration<br>* All patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime & Bond Universal.<br>* Other names: composite resin restorations with Prime & Bond Universal adhesive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate of restoration | The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = retained. Charlie = mobility or loss. | 01 year | 
| Retention rate of restoration | The retention rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = retained. Charlie = mobility or loss. | 02 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal staining rate of restoration | The marginal staining rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no staining. Bravo = superficial staining (localized or generalized). Charlie = deep staining (localized or generalized). | 01 year | 
| Marginal staining rate of restoration | The marginal staining rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no staining. Bravo = superficial staining (localized or generalized). Charlie = deep staining (localized or generalized). | 02 years | 
| Marginal Adaptation rate of restoration | The marginal adaptation rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no visible evidence of a crack along the edge, the explorer will not penetrate. Bravo = visible evidence of a crack along the margin, dentin unexposed, clinically acceptable. Charlie = explorer penetrates the crack, dentin exposed, clinically unacceptable. | 01 year | 
| Marginal Adaptation rate of restoration | The marginal adaptation rate will be assessed following the USPHS (United States Public Health) guidelines with the following classifications (acronyms): Alpha = no visible evidence of a crack along the edge, the explorer will not penetrate. Bravo = visible evidence of a crack along the margin, dentin unexposed, clinically acceptable. Charlie = explorer penetrates the crack, dentin exposed, clinically unacceptable. | 02 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adhesives, dental bonding