NCT05432258

Nano-Hybrid vs Bulk-Fill Resin Composites

Evaluation of the Nano-Hybrid and Bulk-Fill Resin Composites: Randomised Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Izmir Katip Celebi University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Composite Resin
• Dental Caries in Children

Interventions

Type	Name	Description
DEVICE	Bulk-fill composite resin	Restoration of the mandibular first molars with bulk-fill composite resin as the manufacturer advises after the cavity preparation
DEVICE	Nano-fill composite resin	Restoration of the mandibular first molars with nano-fill composite resin as the manufacturer advises after the cavity preparation

Timeline

• Start date: 2020-06-15
• Primary completion: 2022-07-26
• Completion: 2022-07-26
• First posted: 2022-06-27
• Last updated: 2023-10-02

Locations

1 site across 1 country: Turkey (Türkiye)