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This study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate 2-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ restorations.
The null hypothesis tested in this study was that, there would be no difference in the 2-year clinical performance of all tested bulk-fill resin composites in Class II restorations.
Forty patients were enrolled in the study. Each patient received three bulk-fill resin composites Class ӀӀ restorations. One dual-cure and two light-cure bulk-fill resin composites were used for Class ӀӀ restorations following manufacturer's instructions. A universal adhesive was used with all restorations. All restorations were clinically evaluated after 1 week (baseline), 6 months, 12 months, 18 months and finally after 24 months using the FDI World Dental Federation criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fill-Up | Active Comparator | Bulk-fill resin composite type |
|
| QuiXfil | Active Comparator | Bulk-fill resin composite type |
|
| Tetric N-Ceram Bulk Fill | Active Comparator | Bulk-fill resin composite type |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fill-Up Class ӀӀ restoration | Procedure | Bulk-fill technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Esthetic properties (FDI criteria) | Including five parameters (surface luster, margin staining, surface staining, color match & translucency, and esthetic anatomical form). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement). | From baseline to 2-year follow-up |
| Functional properties (FDI criteria) | Including five parameters (marginal adaptation, occlusal wear, proximal contact, radiographic examination, and fracture of material & retention). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement). | From baseline to 2-year follow-up |
| Biological properties (FDI criteria) | Including three parameters (post-operative sensitivity, recurrence of caries, and tooth integrity). Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome. Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement). | From baseline to 2-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria:
Specific exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Mansoura University, Mansoura, Egypt. | Al Mansurah | Aldakhlia | 35516 | Egypt |
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Each patient received three Class ӀӀ restorations with the three tested bulk-fill resin composites.
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Except the investigator, the participants and the two clinical examiners were blinded to the type of bulk-fill resin composite applied in each tooth (a double-blinded clinical trial).
| QuiXfil Class ӀӀ restoration |
| Procedure |
Bulk-fill technique |
|
| Tetric N-Ceram Bulk Fill Class ӀӀ restoration | Procedure | Bulk-fill technique |
|