A 5-year Clinical Trial Assessing the Effects of a Surface Sealant on Composite Resin Class I Restorations
Condition: Definitive Restorations, Longevity
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial, based on a split mouth and double-blind design, will evaluate the effects of a
      surface sealant on the clinical performance of composite resin class I restorations.
      According to eligibility criteria, 10 pairs of upper and lower molars or premolars will be
      restored with Esthet X composite resin. For each pair, one surface will be sealed with
      Lasting Touch surface sealant. A clinical evaluation will be performed by two experienced
      operators using modified USPHS (United States Public Health service) after 5 years after
      treatment. Data will be analyzed using the McNemar test (p < 0.05).
    

Detailed description: 
      The protocol was approved by the Human Ethics Committee (protocol number 133/2010, CAAE
      0124.0.224.000.-10), and all patients will sign informed consent forms and complete a
      registration form prior to treatment.

      The eligibility criteria for participation in the study include good oral hygiene, a class I
      caries lesion or unsatisfactory restoration in at least two posterior teeth (molar or
      premolar), a buccolingual extension, and a signed consent form. The exclusion criteria
      includes patients with a proximal caries lesion, the presence of periodontal disease,
      symptomatic restored or nonrestored teeth indicating irreversible pulpal pathology, an
      abnormal occlusion or the absence of antagonist teeth, exposure of pulpal tissue, and
      extended or large cavities.

      This study will include 10 patients (aged 18 to 45 years) totaling 14 pairs of class I
      restorations (molars and premolars). These pairs will be randomly divided into two study
      groups, resulting in a split-mouth design.

      A hybrid resin composite, Esthet X (Dentsply, Caulk, USA) and an etch-and-rinse two-step
      adhesive, AdperTM Single Bond (3M, ESPE) will be used for the composite restorations. For
      teeth with the surface sealant, they will be covered with Lasting Touch (Dentsply, Caulk,
      USA).

      All cavity preparations and restorations will be performed by the same experienced operator,
      using rubber dam isolation. Cavity designs will be prepared using a #245 carbide bur (KG
      Sorensen, Cotia, SP, Brazil), which will be changed every five preparations. All enamel
      bordered cavity margins will be verified.

      The restorative procedures will be performed using rubber dam isolation. In very deep
      cavities, the dentin will be covered with calcium hydroxide (Dycal; Dentsply Ind. e Com.
      Ltda., Petrópolis, RJ, Brazil) and resin-modified glass-ionomer cement (Vitrebond, 3M ESPE,
      St. Paul, MN, USA). In deep cavities dentin will be covered solely with resin-modified
      glass-ionomer cement.

      The enamel and dentin will be etched with 37% phosphoric acid (Scotchbond Etchant; 3M/ESPE,
      St. Paul, MN, USA) for 30 s and 15 s, respectively. Then will be rinsed with water spray for
      30 s and gently and thoroughly dried with absorbent paper for 10 s.

      Two coats of one-bottle adhesive (Adper TM Single Bond 2, 3M/ESPE, St. Paul, MN, USA) will be
      applied homogeneously to the surface with a disposable micro-brush. The cavity will be gently
      brushed with a faint air jet, allowing solvent evaporation, and light-cured for 10 s with an
      LED light (Smart Lite OS, Dentsply Indústria e Comércio Ltda., Rio de Janeiro/RJ - Brasil),
      with 1270 mW/cm2 of power density.

      The class I teeth cavities will be restored with 2 mm increments of composite resin, by using
      a steel instrument (XTS Goldstein Flexi-Thin Mini #3, Hu-Friedy, Rio de Janeiro, RJ), and
      light-cured for 20 s, with the same light source and power density.

      The finishing and polishing procedures will be performed after seven days, using fine diamond
      and multilaminated burs, followed by a one step polishing system Pogo (Dentsply, Caulk, USA).
      These procedures will be performed using a slow-speed hand piece with water spray. The disks,
      burs, and points will be discarded after each use.

      For teeth assigned to the control group (NSS), they will be treated with finishing and
      polishing procedures only. Teeth included in SS group will be covered using a nanotechnology
      liquid polish system (Lasting Touch, Dentsply Caulk, Milford, DE, USA) applied as per the
      manufacturer's directions after finishing and polishing.. For this application, the composite
      surface and 1 mm external limit will be etched with a 37% acid phosphoric acid gel for 30 s
      and thoroughly rinse. The excess water will be removed with a mild oil free air stream, as
      per the manufacturer's instructions. Utilizing a disposable micro brush, a uniform layer of
      low-viscosity agent will be applied over the etched area, gently air brushed for 15 s and
      light-cured with the same light source.

      The quality of the restorations will be rated according to the U.S. Public Health System/Ryge
      criteria. Two independent experienced examiners assessed the restorations. Restorations will
      bee calibrated according to Cohen's Kappa. Where disagreement occurred during evaluation, a
      consensus will be obtained among the examiners. It will be a double-blind evaluation, as
      neither examiner nor patients knew the treatment under evaluation. Examinations will be
      performed directly using mirror and probe. The evaluations will obtained at baseline (1 to 2
      weeks after insertion) and 5 year after treatment. The parameters included will be marginal
      discoloration, anatomic form, secondary caries and marginal integrity. Data will be
      statistically analyzed using the McNemar's test (p < 0.05).
    

Intervention name(s): Surface sealant; No surface sealant
Intervention type(s): Procedure; Procedure
Intervention description(s): Device:
Enamel and dentin etching with 37% phosphoric acid (Scotchbond Etchant; 3M/ESPE, St. Paul, MN, USA) for 30 s and 15 s.
Two coats of one-bottle adhesive (Adper TM Single Bond 2, 3M/ESPE, St. Paul, MN, USA) will be applied homogeneously to the surface with a disposable micro-brush.
Cavities will be restored with 2 mm increments of composite resin (Z350, 3M/ESPE, St. Paul, MN, USA)
7 Days after: Finishing and polishing will be performed with fine diamond and multilaminated burs, one step polishing system Pogo (Dentsply, Caulk, USA).
The composite surface and 1 mm external limit will be etched with a 37% acid phosphoric and after will be covered using a nanotechnology liquid polish system (Lasting Touch, Dentsply Caulk, Milford, DE, USA).; Device:
Enamel and dentin etching with 37% phosphoric acid (Scotchbond Etchant; 3M/ESPE, St. Paul, MN, USA) for 30 s and 15 s.
Two coats of one-bottle adhesive (Adper TM Single Bond 2, 3M/ESPE, St. Paul, MN, USA) will be applied homogeneously to the surface with a disposable micro-brush.
Cavities will be restored with 2 mm increments of composite resin (Z350, 3M/ESPE, St. Paul, MN, USA)
7 Days after: Finishing and polishing will be performed with fine diamond and multilaminated burs, one step polishing system Pogo (Dentsply, Caulk, USA).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: composite resin; surface sealant