MedTrace Logo

Nano-Hybrid vs Bulk-Fill Resin Composites

NCT05432258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2023-10-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2022-07-26
Completion
2022-07-26

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05432258 on ClinicalTrials.gov