Clinical Performance of Different Adhesive Strategies With a Universal System in Sclerosed Dentin in NCCL: A Double-blind Randomized Clinical Trial.

Study Overview
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Brief Summary
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The aim of this randomized, prospective, parallel, double-blind clinical trial will be to evaluate the clinical performance of restorations performed in non-carious cervical lesions (NCCL) using a soft ph universal adhesive system, varying the adhesive strategy (self-etching vs. selective etching of the enamel) and the sclerosis characteristics of the dentinal substrate over 24 months.

Detailed Description
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Two hundred restorations will be performed in NCCL of volunteers of both genders, by a single operator, using the Single Bond Universal(3M ESPE) adhesive system. The restorations will be randomly allocated into 4 groups (n-50): D-SE (absence of dentinal sclerosis and self-etching protocol); D-SELETIVE (absence of dentinal sclerosis and selective enamel etching protocol); SD-SE (sclerotic dentin and self-etching protocol); SD-SELETIVE (sclerotic dentin and selective enamel etching protocol). The randomization process within subject was performed by computer-generated tables by a staff member not involved in the research protocol. Details of the allocated group were recorded on cards contained in sequentially numbered, opaque, sealed envelopes. These were prepared by a staff member who was not involved in any of the phases of the clinical trial. The allocation assignment was revealed by opening the envelope on the day of the restorative procedure.The operator was not blinded to group assignment when administering. The evaluations of the clinical performance of the restorations will be carried out by two previously calibrated examiners, adopting the criteria of the United States Public Health Service (USPHS) for the variables retention, marginal adaptation, marginal staining and postoperative sensitivity . The intragroup statistical analysis will be performed using the McNemar test for the variables retention and postoperative sensitivity; and by Wilcoxon for adaptation and marginal staining. To compare the clinical performance inter groups in the different assessment intervals, Fisher's exact test (retention and postoperative sensitivity) and Kruskal-Wallis (adaptation and marginal staining) will be used.

Official Title
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Clinical Performance of Different Adhesive Strategies With a Universal System in Sclerosed Dentin in NCCL: A Double-blind Randomized Clinical Trial.

Conditions
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Sclerotic Dentine, Non Carious Cervical Lesion

Intervention / Treatment
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* Procedure: Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentin
* Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentin
* Procedure: Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentin
* Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health status Good oral hygiene Absence of periodontal disease Minimum of 20 teeth in occlusion Presence at least one (01) non-carious cervical lesion in a tooth with pulp vitality. Non-carious cervical lesion greater than 1mm in depth. Non-carious cervical lesion involving enamel and dentin. Exclusion Criteria: Non- carious cervical lesion cavo surface margin involving more than 50% of the enamel. NCCL in crack teeth. Absence of opposing teeth and/or adjacent to the lesion. Presence of occlusal trauma in the NCCL tooth Presence of orthodontic appliance or removable partial denture with retention in the tooth where the lesion is located Patients that underwent tooth whitening procedures within a period of less than 14 days from the date of restoration Patients with high risk of caries (presence of three or more active caries lesions) Xerostomia Bruxism Pregnant women Patients who do not accept the study 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 |
| --- | --- |
| Experimental: D-SE<br>Absence of dentinal sclerosis and self-etching adhesive protocol | Procedure: Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentin<br>* The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the D-SE group, the universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.<br>|
| Active Comparator: D-SELETIVE<br>Absence of dentinal sclerosis and selective enamel etching adhesive protocol | Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentin<br>* The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the D-SELETIVE group a 37% phosphoric acid will be applied only at the enamel margin for 15s, then rinsed with water for 20s, and slightly dry. The universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.<br>|
| Experimental: SD-SE<br>Sclerotic dentin and self-etching adhesive protocol | Procedure: Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentin<br>* The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the SD-SE group, the universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.<br>|
| Experimental: SD-SELETIVE<br>Sclerotic dentin and selective enamel etching adhesive protocol | Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentin<br>* The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the SD-SELETIVE group a 37% phosphoric acid will be applied only at the enamel margin for 15s, then rinsed with water for 20s, and slightly dry. The universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure. | 1 year | 
| Retention | The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal adaptation | Marginal adaptation will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - Restoration is continuous with existing anatomic form. Bravo - Detectable V-shaped defect in enamel only. Catches explorer going both ways Charlie - Detectable V-shaped defect to dentin-enamel junction | 1 year | 
| Marginal adaptation | Marginal adaptation will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - Restoration is continuous with existing anatomic form. Bravo - Detectable V-shaped defect in enamel only. Catches explorer going both ways Charlie - Detectable V-shaped defect to dentin-enamel junction | 2 years | 
| Marginal staining | Marginal staining will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - No discoloration along the margin Bravo - Slight and superficial staining (removable, usually localized). Charlie - Deep staining cannot be polished away | 1 Year | 
| Marginal staining | Marginal staining will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - No discoloration along the margin Bravo - Slight and superficial staining (removable, usually localized). Charlie - Deep staining cannot be polished away | 2 Years | 

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