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NCT05432258

Nano-Hybrid vs Bulk-Fill Resin Composites

Completed NA Last updated 2 October 2023
What this trial tests

NA trial testing Bulk-fill composite resin in Composite Resin in 89 participants. Completed in 26 July 2022.

Timeline
15 June 2020
Primary endpoint
26 July 2022
26 July 2022

Quick facts

Lead sponsorIzmir Katip Celebi University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment89
Start date15 June 2020
Primary completion26 July 2022
Estimated completion26 July 2022
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Izmir Katip Celebi University

Who can join

Adults 6 to 12, any sex, with Composite Resin or Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Two-year evaluation of a nano-hybrid and a bulk-fill resin composite: a randomized, double-blind split-mouth clinical study.
    Çağırır Dindaroğlu F, Yılmaz E. · · 2024 · cited 7× · PMID 38467942 · DOI 10.1007/s00784-024-05592-8

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