Selective Enamel Etching in Self-etching Adhesives: a 2-year Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems applied with or without selective enamel etching.

Detailed Description
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The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems: Clearfil SE Bond (Kuraray Noritake, Japan) and Xeno V + (Dentsply De Trey, Germany) applied with or without 36% phosphoric acid enamel etching. Assessments were at baseline, 3, 6, 12, 18 and 24 months of clinical service.

Official Title
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Effectiveness of One- and Two-step Self-etching Adhesives Applied With or Without Selective Enamel Etching: a 2-year Randomized Controlled Clinical Trial

Conditions
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Selective Enamel Etching in Dental Restorations

Intervention / Treatment
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* Drug: Selective enamel etching with 36% phosphoric acid
* Drug: No selective enamel etching with 36% phosphoric acid
* Device: Clearfil SE Bond
* Device: Xeno V


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years; Present at least 4 NCCLs in vital teeth with margins in enamel and dentin (and its largest area in dentin), independently of teeth location; Non-smoking; Read and sign the Statement of Informed Consent. Exclusion Criteria: Compromised medical history; Severe or chronic periodontitis; Extreme caries sensitivity; Heavy bruxism; Under orthodontic treatment; Poor oral hygiene; Smokers.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clearfil SE Bond Etch (CSE-E)<br>CSE-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. Selective enamel etching with 36% phosphoric acid | Drug: Selective enamel etching with 36% phosphoric acid<br>* Etch: selective 36% phosphoric acid enamel etching<br>* Other names: 36% phosphoric acid;Device: Clearfil SE Bond<br> <br> |
| Active Comparator: Xeno V+ Etch (XV-E)<br>XV-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. Selective enamel etching with 36% phosphoric acid | Drug: Selective enamel etching with 36% phosphoric acid<br>* Etch: selective 36% phosphoric acid enamel etching<br>* Other names: 36% phosphoric acid;Device: Xeno V<br> <br> |
| Active Comparator: Clearfil SE Bon Non-etch (CSE-NE)<br>CSE-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. No selective enamel etching with 36% phosphoric acid | Drug: No selective enamel etching with 36% phosphoric acid<br>* Non-etch: without phosphoric acid selective enamel etching<br>* Other names: Without 36% phosphoric acid;Device: Clearfil SE Bond<br> <br> |
| Active Comparator: Xeno V+ Non-etch (XV-NE)<br>XV-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points. No selective enamel etching with 36% phosphoric acid | Drug: No selective enamel etching with 36% phosphoric acid<br>* Non-etch: without phosphoric acid selective enamel etching<br>* Other names: Without 36% phosphoric acid;Device: Xeno V<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration retention rate as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months |  | Baseline, 3, 6, 12, 18 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration marginal integrity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months |  | Baseline, 3, 6, 12, 18 and 24 months | 
| Restoration marginal staining as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months |  | Baseline, 3, 6, 12, 18 and 24 months | 
| Secondary caries as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months |  | Baseline, 3, 6, 12, 18 and 24 months | 
| Post-operative sensitivity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months |  | Baseline, 3, 6, 12, 18 and 24 months | 
| Pulp vitality as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months |  | Baseline, 3, 6, 12, 18 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical lesions, Clinical trial, Self-etch adhesive