36-Month Clinical Evaluation of a Universal Adhesive

Study Overview
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Brief Summary
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The aim of this clinical trial was to evaluate and compare the performance of a universal adhesive with different adhesive strategies in the restoration of non-carious cervical lesions (NCCLs) over a 36-month period.

Detailed Description
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One hundred sixty-five NCCLs in 35 patients (13 female, 22 male) with at least 3 lesions were included in this study. Three groups were formed according to adhesive strategies used (n=55): selective-etch mode; etch-and-rinse mode (ER); or self-etch (SE) mode of a universal adhesive, Single Bond Universal. The same nanofilled resin composite, Filtek Ultimate was used for all restorations by a single operator. The restorations were evaluated by two calibrated examiners at baseline and at 6-, 12-, 18-, 24- and 36- months in accordance with the modified USPHS criteria. The Chi-square test was used for intergroup, the Cochran Q test was used for intragroup comparison.

Official Title
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36-Month Clinical Evaluation of Different Adhesive Strategies of a Universal Adhesive

Conditions
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Non-Carious Cervical Lesions

Intervention / Treatment
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* Device: Scotchbond Universal Adhesive (3M ESPE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years old good oral hygiene available for recall at least 20 teeth under occlusion the presence of at least three non-carious cervical lesions Exclusion Criteria: poor oral hygiene bruxism habits severe or chronic periodontitis If the teeth selected for study, were nonvital, or had any restorations on other surfaces were not included.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scotchbond universal adhesive (etch-and-rinse)<br>Acid etch (enamel&dentin)+adhesive agent Intervention: Device: Adhesive agent | Device: Scotchbond Universal Adhesive (3M ESPE)<br>* Adhesive system<br>|
| Experimental: Scotchbond universal adhesive (selective-etch)<br>Acid etch (only enamel)+adhesive agent Intervention: Device: Adhesive agent | Device: Scotchbond Universal Adhesive (3M ESPE)<br>* Adhesive system<br>|
| Experimental: Scotchbond universal adhesive (self-etch)<br>Adhesive agent Intervention: Device: Adhesive agent | Device: Scotchbond Universal Adhesive (3M ESPE)<br>* Adhesive system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal adaptation | Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed | From baseline to 36 month | 
| Marginal staining | Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction | From baseline to 36 month | 
| Retention | Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material | From baseline to 36 month | 
| Postoperative sensitivity | Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. Charlie:constant sensitivity, not diminishing in intensity | From baseline to 36 month | 
| Seconder caries | Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries present. Charlie: Caries present | From baseline to 36 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Carious Cervical Lesions, Universal adhesive