Clinical Evaluation of SI-R21204 Versus Nano-hybrid Resin Composite: A Prospective Controlled Clinical Trial
Condition: Caries
Study type: Interventional

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.
    

Detailed description: 
      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.
      Giomers are a new group of anhydrous resin based direct adhesive restorative materials based
      on the filler technology (PRG) to form a stable phase of glass ionomer in the restorative.
      These materials have both advantages of glass ionomers namely, fluoride release and recharge,
      and resin composites with excellent optical and mechanical properties. PRG fillers are
      fabricated by acid-base reaction of glass particles and polyacrylic acid in the presence of
      water and forms wet silicous hydrogel. S-PRG filler particles exhibit a three-layer structure
      where the glass core is enveloped by a stable glass-ionomer hydrogel. This hydrogel is
      surrounded by the "reforming phase," which provides structural protection for the hydrogel.
      These materials with S-PRG technology therefore, differ from polyacid modified composite
      resins because the glass ionomer hydrogel forms only after water uptake by the compomer resin
      matrix after polymerization. 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 study will be carried
      out as a prospective study, with assessment of the restorationsafter three year.

      The project includes 40 patients. Most of the patients have been recruited from the Istanbul
      Medipol University Dental Clinics in Istanbul. After giving their consent to take part in the
      study Class I & II restorations of both upper and lower molars and premolars are
      performed.The treatment procedure is: The patients are offered local anesthetic before
      treatment start. The cavity is excavated and filled according to the guidelines for composite
      restorations.

      The control procedure is:

      The restoration is evaluated according to marginal adaptation, cavo surface marginal
      discoloration, approximal contact, fractures, caries associated with restorations and
      postoperative hypersensitivity. The controls will take place after two weeks, one year, two
      years and three years.
    

Intervention name(s): SI-R21204 resin composite; Nanohybrid resin composite
Intervention type(s): Device; Device
Intervention description(s): 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.; One of the cavities will be restored with a nanohybrid resin composite (Clearfil Majesty) as a control restoration wth ordinary restorative techniques.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clinical study; dental fillings