Clinical Evaluation of Fiber Reinforced Resin Composite Base Versus Incremental Packing of Nanohybrid Resin Composite
Condition: Caries Class II
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A clinical trial, comparing two different incrementation techniques in the restoration of
      proximal caries in permanent posterior teeth . One utilizes a fiber reinforced bulk fill base
      material, followed by an occlusal nanohybrid capping layer. The other utilizes incremental
      packing of nanohybrid resin composite material to fill the whole cavity.
    

Detailed description: 
      The aim of this study is to conduct an RCT to evaluate the clinical performance of the fiber
      reinforced bulk fill resin composite in comparison to incremental packing of nanohybrid resin
      composite.

      Examination and selection of all patients will be done according to inclusion and exclusion
      criteria. Diagnosis of patients' chief complaint and teeth that will be involved in this
      study will be done. Teeth are to be chosen according to standardized radiographic
      examination. Teeth should have proximal, primary deep carious lesions involving 2/3 of the
      entire dentin thickness with no continuity between the carious cavity and the pulp chamber.

      A Class II cavity will be prepared after local anesthesia has been given as required. The
      cavity will be prepared using a high-speed hand-piece with air and water coolant and diamond
      burs of different sizes. Sharp excavators will allow accessible removal of soft carious
      lesions will be used. Any tooth that will suffer from pulpal exposure will be excluded from
      the study. Finishing of the cavity walls will be done using a fine-grit, yellow coded,
      diamond bur.

      Rubber dam isolation will be done.

      Sectional matricing and wedging will be done. Followed by, placement of restorative material
      according to the randomization sequence.

      A closed centripetal technique will be utilized, where a proximal wall will be built using
      nanohyrbid resin composite first, followed by filling of cavity with bulk-fill fiber
      reinforced resin composite material in increments of 3-4mm, as required to end up with
      leaving an occlusal space on top of at least 2mm. Then, an occlusal increment of nanohybrid
      resin composite will be applied. Finally finishing and occlusal adjustment will be done under
      water spray by using superfine diamond burs. Polishing will be done using pre-impregnated
      rubber cups. Materials will be manipulated according to manufacturer instructions.

      A closed centripetal, oblique incrementation technique will be used to completely fill the
      whole cavity. Increments should be of 2mm thickness or less and should be placed obliquely
      from the cavity walls. Then finishing and occlusal adjustment will be done under water spray
      by using superfine diamond burs. Polishing will be done using pre-impregnated rubber cups.
      Materials will be manipulated according to manufacturer instructions

      Outcome Measuring Device: modified USPHS criteria .

      Primary Outcomes:

      Mechanical evaluation:

      Fracture and Retention Marginal integrity Marginal Discoloration Anatomic Form Surface
      Texture Proximal Contact Radiographic Examination

      Secondary Outcomes:

      Biological evaluation:

      Postoperative Sensitivity Recurrent Caries
    

Intervention name(s): EverX Posterior; Resins, Composite
Intervention type(s): Drug; Drug
Intervention description(s): fiber reinforced bulk fill resin composite; incremental packing of Nanohybrid Resin composite
Other intervention name(s): Fiber reinforced bulk fill dentine substitute; Universal Restorative Nanohybrid resin composite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment