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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clearfil SE | Active Comparator | Group containing 10-MDP and HEMA monomers |
|
| Optibond All-in-One | Active Comparator | Group containing HEMA monomer |
|
| Prime & Bond Universal | Active Comparator | Control Group containing other monomers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| composite resin restoration | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative sensitivity rate of restoration | present or absent | 01 year |
| Postoperative sensitivity rate of restoration | present or absent | 02 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberta Oliveira, Msc | Federal University of Pará | Principal Investigator |
| Brennda De Paula, Msc | Federal University of Pará | Study Chair |
| Cecy Silva, PhD | Federal University of Pará | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Para's Federal University | Belém | Pará | 66075-110 | Brazil |
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| ID | Term |
|---|---|
| C035382 | PRIME protocol |
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|
| 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 |
| Secondary caries rate of restoration | present or absent | 01 year |
| Secondary caries rate of restoration | present or absent | 02 years |