Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations
Condition: Dental Caries Class I; Dental Caries Class II
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Purpose of the Study:This study was to evaluate the 1 week, 1 year safety and effectiveness
      of dental composite resin (Filtek™ Bulk Fill Posterior Restorative) in restoring Class I and
      II dental cavities in posterior teeth.
    

Detailed description: 
      This was a randomized, two- arm, non-inferiority study to evaluate the safety and clinical
      performance of resin composite, Filtek™ Bulk Fill.

      Test apparatus: Apparatus for Test: Filtek™ Bulk Fill Posterior Restorative Apparatus for
      Control: 3M™ ESPE™ Filtek™ Z350XT, was approved by CFDA in 2010 and had been in the market
      for 5 years with some validated clinical data.

      Sample Size of Subjects: Two-hundred forty (240) patients were expected to be recruited into
      the study and were randomly assigned to the test group and the control group according to the
      ratio of 1: 1; thus the number of cases in each group was 120. Finally, a total of 240
      subjects were randomly enrolled in the study, including 120 subjects in the test group and
      120 subjects in the control group, which met the required sample size.

      The study consisted of screening period (initial screening visit, post-preparation screening
      visit), 1-week follow-up visit and 1-year follow-up visit, during which all the tests
      required in the protocol would be conducted to select the subjects meeting the criteria for
      inclusion. The examination and evaluation of the initial screening period were supposed to be
      completed within 0.5 days. Then investigators would make an appointment with the subjects
      eligible for the initial screening for cavity preparation and tooth filling, the required
      time of which depended on the complexity of the tooth problem and would be completed within
      0.5 days. Immediate evaluation of relevant indicators were offered to the subjects who were
      selected and qualified after preparation and patients with qualified score would continue to
      have the 1-week and 1-year follow-up visits.

      Subjects were randomly assigned to either the test group (Filtek™ Bulk Fill Posterior
      Repository) or the control group (Filtek™ Z350XT) in a central random manner, using the
      corresponding test product or control product to fill and restore posterior teeth defects
      (class I or class II cavities).

      Since all investigators were required to operate according to instructions, it was clear to
      them which product a subject was given. However, subjects and clinical evaluators were
      blinded regarding whether the test product (Filtek™ Bulk Fill Posterior Repository) or the
      control product (Filtek™ Z350XT) was used by the subjects.

      Immediately after restoration placement, at 1 week and 1 year postoperative, two or three
      clinical evaluators from each site performed the clinical assessment (the third more senior
      evaluator performed the assessment and determination if the first two evaluators were not in
      agreement) per China Technical Instruction and Guidance of Resin Composite Restoration
      Material For CFDA Registration (Technical Instruction and Guidance in short). The clinical
      acceptable rate of the restoration at 1 year was the primary endpoint in this study.

      AE/SAE were collected to evaluate the safety of Filtek™ Bulk Fill. Based on the assessment
      result, if the clinical acceptance rate of the two groups achieved the clinical acceptable
      rate defined in the protocol, it indicated that Filtek™ Bulk Fill was efficacious for class 1
      and II restorations.
    

Intervention name(s): Filtek™ Bulk Fill Posterior Restorative; Filtek™ Z350XT Universal Restorative
Intervention type(s): Device; Device
Intervention description(s): The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.; The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.
Other intervention name(s): Filtek™ Supreme Ultra Universal Restorative; Filtek™ Supreme XTE Universal Restorative; Filtek™ Ultimate Universal Restorative
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental restorative; Composite posterior restorative