Release of Organic Components of a GIOMER in Non-carious Cervical Lesion Restorations
Condition: Non-carious Cervical Lesions
MeSH terms: Uterine Cervical Diseases
Study type: Interventional

Summary: 
      To evaluated the clinical performance of composite resin restorations, considering also the
      evaluation of release of resin components into saliva and the presence cytokines in gingival
      fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite
      restorative) were use. For in vitro assays, adhesive and resin specimens are being preparing
      for assessing the monomers degree of conversion (by FTIR), sorption and solubility and
      release of resinous components in ethanol and Ringer solutions (through a gas chromatography
      and mass spectroscopy - GC-MS). In the longitudinal clinical study clinical performance of
      restorations and periodontal response were evaluate.
    

Detailed description: 
      Release of components of a resin composite system containing pre-reagent vitreal particles:
      laboratory and patient studies. The objectives of this study was to evaluate physical and
      chemical properties of a methacrylate-based restorative system regarding to the release of
      resin components to the storage medium, to evaluate the clinical performance of composite
      resin restorations, considering also the evaluation of release of resin components into
      saliva and the presence of cytokines in gingival crevicular fluid. Restorative system FL-Bond
      II (self-etching adhesive system)/ beautifil II (composite restorative) were use. For in
      vitro assays, adhesive and resin specimens are being preparing for assessing the monomers
      degree of conversion (by FTIR), sorption and solubility and release of resinous components in
      ethanol and Ringer solutions (through a gas chromatography and mass spectroscopy - GC-MS). In
      the longitudinal clinical study, patients who present a NCCL with restorative need were
      selecting. Prior to treatment, there will be periodontal evaluation, saliva and gingival
      crevicular fluid collection (controls). The lesions were restoring with the restorative
      system. After 10 min,7 days, 1 and 6 months, clinical performance of restorations and
      periodontal response were evaluate according to the criterion FDI. Additionally, in all of
      these evaluation periods samples of saliva and crevicular fluid are being collecting. Saliva
      samples will be analyze by GC-MS to identify the eventual presence of organic components
      derived from the restoration. The crevicular fluid samples were analyzing using ELISA for
      identification and quantification of interleukins.
    

Intervention name(s): Device: SHOFU beautifil II LS
Intervention type(s): Other
Intervention description(s): Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were used following manufacturer's instructions
Intervention model: Single Group Assignment
Intervention model description: This is a single-center, non-blinded, clinical trial 6 months in duration.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resin composite; clinical trial; biocompatibility; cytokines