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The present study was designed to provide further evidence in this particular research prospective, and this study hence aimed to clinically evaluate the 5-years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations. The formulated null hypothesis was that there is no significant difference in the clinical performances of the three different resin cement strategies for luting indirect resin composite inlays in MOD Class II restorations for 5-years.
The research question was as follows: Do self-adhesive resin cements in class II restorations present better clinical performances than conventional etch-and-rinse and self-etch resin cements according to the USPHS criteria?
Objective: To clinically evaluate the 5 years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations.
Materials and Methods: A randomized clinical trial was conducted following the protocol, 40 patients with three large cavities for each one that indicated for indirect MOD Class II restorations were enrolled in the current study. Then, 120 indirect resin composite inlay restorations (SR Nexco) were placed and luted with three different resin cement strategies; an etch-and-rinse (Variolink N), self-etch (Panavia F2.0) and self-adhesive (RelyX Unicem). Each resin cement was used for luting 20 inlay restorations. A single operator placed all restorations according to the manufacturer's instructions. Immediatelly after placement, the restorations were finished and polished. Clinical evaluation was performed at baseline and at 1, 3 and 5 years intervals after placement by two independent examiners using modified USPHS criteria. The changes in the USPHS parameters during the 5 years period were analyzed with Fredman test. The baseline scores were compared with those at the recall visits using Wilcoxon signed rank test, where the level of significance was set at p˂0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etch-and-rinse (Variolink N) resin cement | Active Comparator | For etch-and-rinse resin cement, 40 inlays were cemented by Variolink N resin cement. |
|
| Self-etch (Panavia F2.0) resin cement | Placebo Comparator | Regarding self-etch resin cement, 40 inlays were cemented by Panavia F2.0 resin cement. |
|
| Self-adhesive (RelyX Unicem) resin cement | No Intervention | For self-adhesive resin cement, 40 inlays were cemented by RelyX Unicem resin cement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etching | Procedure | Etching enamel surface using phosphoric acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage % of patients with marginal staining | Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement. | 5 years after restoration procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
study Protocol, Statistical Analysis Plan can be shared to other researchers
Data will be available within 3 Months for 5 years
For anyone
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| ID | Term |
|---|---|
| D003763 | Dental Leakage |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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