Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to compare the 2-year clinical performance of bulk-fill composites, which can be applied as a single layer, and the nano-hybrid filled composite resins, which are frequently used in clinical routine, in children in a split-mouth design.
This study was conducted on 89 patients aged 6-12 years who had caries on bilateral mandibular first molars. Our study has a randomized, cross-controlled, and double-blind design. In split-mouth design, restorations of mandibular permanent molars completed with nano-hybrid ORMOCER based bulk-fill filling material Admira Fusion x-tra (Voco GmbH, Cuxhaven, Germany) and nano-hybrid composite Grandio (Voco , Cuxhaven, Germany). Futurabond U single dose (Voco, Cuxhaven, Germany) universal adhesive was used for all restorations, in the selective enamel etching mode. The clinical success of the restorations will be evaluated at 6, 12 and 24-month controls. Evaluations has been made by two physicians other than the one who did the restoration, who do not know which restorative material was applied to which tooth.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bulk-fill composite resin | Experimental | Bulk-fill Ormocer composite resin restorations on the mandibular first molars applied in layers of 4 mm depth |
|
| Nano-fill composite resin | Active Comparator | Nano-fill composite resin restorations on the mandibular first molars were applied in layers of 2 mm depth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulk-fill composite resin | Device | Restoration of the mandibular first molars with bulk-fill composite resin as the manufacturer advises after the cavity preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of clinical performances between two restorative materials according to World Dental Federation (FDI)(1-5 scale; 1 best, 5 worst) | Change of World Dental Federation (FDI) scores of restoration from baseline to 2 year | immediately after restoration and 24 months control |
| Comparison of clinical performances between two restorative materials according to US Public Health Service (USPHS) criteria (Alfa-best, Bravo, Charlie-worst) | Change of the US Public Health Service (USPHS) scores of restoration from baseline to 2 year | immediately after restoration and 24 months control |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Katip Celebi University | Izmir | Turkey (Türkiye) |
Not provided
In a split-mouth design, 89 patients' 2 mandibular first molars were divided into 2 groups. Per patient, one mandibular first molar had bulk-fill ormocer-based composite resin restoration and 1 mandibular first molar had nanofill composite resin restoration via incremental technic.
Not provided
Not provided
Double blind
|
| Nano-fill composite resin | Device | Restoration of the mandibular first molars with nano-fill composite resin as the manufacturer advises after the cavity preparation |
|
|