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Clinical Evaluation of SI-R21204 Versus Nano-hybrid Resin Composite: A Prospective Controlled Clinical Trial

NCT02823769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-21

No results posted yet for this study

Summary

Despite the advances in adhesive restorative techniques and materials, dental caries still remains a critical concern even today. In addition, recurrent caries related to microleakage is a common mode of failure of directly placed resin composite restorations. Resin composites are particularly susceptible to recurrent caries due to polymerization contraction and also imperfect adhesion of restorative to tooth tissue. Thus, strong durable bond between adhesive restoratives and tooth tissue and increasing the resistance of teeth to acid by encouraging the development of remineralization are essential to withstand secondary caries. Fluoride has been documented as a major contributing factor for the decline in the incidence of dental caries and also it has been accepted as an agent in the prevention of caries. Giomers are a new group of anhydrous resin based direct adhesive restorative materials based on the filler technology (PRG) have both advantages of glass ionomers namely, fluoride release and recharge, and resin composites with excellent optical and mechanical properties. The chemistry of Giomer materials facilitates fluoride ion release with the potential for a lower incidence of recurrent caries that was accepted as a major factor to retreat a resin restoration. Limited number of studies is available on their fluoride release, and polishability, as well as clinical survival.

The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material "SI-R21204 resin composite" versus a "nano-hybrid resin com-posite" materials for Class I and Class II cavities that needs to be restored in per-manent teeth.40 patients are recruited to the project which is carried out at the School of dentistry, Istanbul Medipol University, Turkey.

Conditions

  • Caries

Interventions

DEVICE

SI-R21204 resin composite

Primary caries of posterior teeth will be restored using SI-R21204 resin composite. Procedures will be done under local anesthesia if necessary. The preperation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.

DEVICE

Nanohybrid resin composite

One of the cavities will be restored with a nanohybrid resin composite (Clearfil Majesty) as a control restoration wth ordinary restorative techniques.

Sponsors & Collaborators

  • Shofu Inc.

    collaborator INDUSTRY

  • Istanbul Medipol University Hospital

    lead OTHER

Principal Investigators

  • Emir Yuzbasioglu, DDS,PhD · Medipol University

  • Mutlu Özcan, DDS,PhD · University of Zurich

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-04-30
Completion
2020-08-16

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT02823769 on ClinicalTrials.gov