Clinical Trial of the Effect of Different Categories of Adhesive System

Study Overview
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Brief Summary
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This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive systems by retention rate of resin restorations placed in non carious cervical lesions with four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1 step self-etch adhesive systems.

Detailed Description
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The etch-and-rinse (3 and 2 steps) and self-etch (1 and 2 steps) adhesive systems allow the bond between the resins restorations with the dental substrates, but they have mechanism of action different. The success of resin composite restorations is reliant upon adhesion to the underlying tooth via adhesive systems. The mechanism of adhesion to enamel and dentine could be involved for one hand, the etching the substrates with 30-40% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin 3 steps etch-and- rinse approach or 2 steps when to combine the primer and adhesive into one bottle. For another hand, the self- etch systems with acid monomers in their primer, allow conditioning the surface without phosphoric acid step. So, they consist of either a self-etching primer accompanied by an adhesive resin applied as a subsequent step (2 steps) or a self-etch adhesive, which does not require a separate primer (1 step).

Official Title
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Randomized Clinical Trial of the Effect of Different Categories of Adhesive System

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: Dental restoration
* Procedure: 3 step ER
* Procedure: 2 step ER
* Procedure: 2 step SE
* Procedure: 1 step SE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health, Patients with acceptable oral hygiene level, Patients with at least 20 teeth under occlusion. Patients with at least four non-carious cervical lesions in four different teeth Patients with maximum of eight lesions that needed to be restored. These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility. Exclusion Criteria: Patients with extremely poor oral hygiene, Patients with severe or chronic periodontitis, Patients with heavy bruxism habits.

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: 3 step ER & Dental restoration<br>Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin. | Procedure: Dental restoration<br>* Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure<br>* Other names: Dental resin restoration;Procedure: 3 step ER<br>* Enamel and dentin will be conditioning with 35% phosphoric acid, then applied primer, and then applied adhesive resin.<br>|
| Experimental: 2 step ER & Dental restoration<br>Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of an adhesive/primer step. | Procedure: Dental restoration<br>* Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure<br>* Other names: Dental resin restoration;Procedure: 2 step ER<br>* Enamel and dentin will be conditioning with 35% of phosphoric acid, then applied primer/adhesive resin.<br>|
| Active Comparator: 2 step SE & Dental restoration<br>Dental restoration with etching the dental substrates with acidic primer, followed by the application of adhesive resin. | Procedure: Dental restoration<br>* Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure<br>* Other names: Dental resin restoration;Procedure: 2 step SE<br>* Enamel and dentin will be conditioning with acidic primer, then applied primer/adhesive resin.<br>|
| Experimental: 1 step SE & Dental restoration<br>Dental restoration with etching and infiltrate the dental substrates with acidic primer/adhesive system. | Procedure: Dental restoration<br>* Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure<br>* Other names: Dental resin restoration;Procedure: 1 step SE<br>* Enamel and dentin will be conditioning with acidic primer/adhesive resin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary caries | Secondary caries near and/or associated of the dental restorations | one year | 
| Retention rate | retention rate of the dental restorations | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal integrity | marginal integrity of the dental restorations | one year | 
| Marginal discoloration | Marginal discoloration of the dental restorations | one year | 
| post-operative sensitivity | dentin post-operative sensitivity | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental adhesive, adhesive systems, Dental Restoration Failure