Clinical Study of Biosilicate Under Resin Composite Restorations in Caries Affected Teeth
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study aimed to evaluate the clinical performance of a novel vitro-ceramic biomaterial
      (Biosilicate®) as treatment of caries-affected dentin in posterior resin restorations. A
      total of 94 restorations of 66 participants were selected and assigned at random into four
      groups: 1 (Biosilicate / Two-step etch and rinse system), 2 (Control / Two-step etch and
      rinse system), 3 (Biosilicate / Two-step self-etching system) and 4 (Control / Two-step
      self-etching system). Two operators carried out the adhesive protocols and restored the
      cavities with a nano-hybrid resin composite (IPS Empress, Ivoclar) using the incremental
      technique. Participants were recalled at one week, 6, 12 and 18 months for clinical
      evaluation performed by two blinders and calibrated examiners according FDI criteria.
    

Detailed description: 
      Background: Dental caries has decreased in recent years, but is still the main oral health
      problem in developed and undeveloped industrialized countries. The purpose of this study is
      to evaluate clinical performance of resin-based composite Class I and II restorations in
      association with Biosilicate.

      Methods: Eighty patients with carious lesions will be receive restorations in premolars and
      molars, which will be randomly allocated in four experimental groups: G1 (Biosilicate,
      AdperSingle Bond 2 and IPS Empress Direct composite), G2 (Adper Single Bond 2 and IPS Empress
      Direct composite), G3 (Biosilicate, AdheSe and IPS Empress Direct composite) e G4 (AdheSE and
      IPS Empress Direct composite) To participate in the clinical trial, qualified subjects must
      meet for inclusion and exclusion criteria. Sixty-four (64) selected volunteers will be fully
      informed on the nature of the study and after had signed a Term of Acceptance defined by the
      Ethics Committee (FORP - USP), they will be invited to participate.

      Carious teeth will be cleaned with a pumice-water slurry and rubber cup to remove salivary
      pellicle and any bacterial plaque. As much as possible, local anesthesia will be. After
      caries removal (high and low-speed handpieces under abundant water irrigation), patients will
      be allocated randomly in the four experimental groups cited above. Final contouring and
      polishing of the restorations will be performed at the same appointment, using a fine-grit
      diamond bur (KG Sorensen), silicon carbide polisher (Viking Kit, KG Sorensen), silicone
      rubber tips (Viking Kit, KG Sorensen) flexible discs (Sof-Lex, 3M ESPE), and polishing pastes
      (Diamond Excel, FGM).

      Two trained and calibrated evaluators, fully blinded to the restorative techniques used, will
      be evaluating the restorations at baseline (one week after placement of restorations), after
      06, 12 and 18 months using FDI criteria. All restorations will be photographed at every
      evaluation point. Esthetic, Functional and Biological proprieties will be used as key
      parameters determining the overall clinical success. Data will be analyzed.
    

Intervention name(s): Adhesive system; Restoration protocol
Intervention type(s): Procedure; Procedure
Intervention description(s): Etch-and-rinse and Self-etch adhesive system will be applied in volunteers that received different types of restoration protocol.; Volunteers will be treated by two types of protocol restoration : 1) Biosilicate (powder) or 2) Control (without Biosilicate). In sequence, adhesive (self-etch or etch and rinse) and composite resin will be used for restoration.
Other intervention name(s): Etch-and-rinse adhesive: Adper Single bond (3M, Brazil); Self-etch: Adhese (2 step self-etch) (Ivoclar, Vivadent); Biosilicate (Vitrovita, Brazil); Control
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Biomaterial; Dental caries; Composite