A 2-year Clinical Impact of Bulk-fill Low-viscosity Resin Composite Liners in Class II Restorations.
Condition: Dental Caries Class II
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This randomized clinical trial evaluated the clinical performance of class II resin composite
      restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without
      a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2
      years. The null hypotheses in the study were as follows: (1) Different types of matrix
      structures (ormocer vs. methacrylate) have no effect on the marginal integrity of
      restorations; (2) A layer of bulk-fill resin compo-site liner of the same category would not
      affect the marginal or internal adaptation of restorations.
    

Detailed description: 
      The study was designed following the Consolidated Standards of Reporting Trials (CONSORT)
      statement. approvement by the local ethics committee of Mansoura University code register was
      taken code M 11120520. The patients were selected as they searched for treatment in the
      Conservative Dentistry Department outpatient clinic, in the Faculty of Dentistry, Mansoura
      University. A group of 30 patients 21 Females and 9 males was chosen from among 92
      participants after careful consideration of the inclusion and exclusion criteria. The sample
      size estimate was made based on the clinical success rate of posterior class II composite
      restorations observed in a prior study (97.5% at 24 months). The sample size needed per group
      was 23 teeth using a significance level of 0.05, power of 80%, and equivalency limit of 15%.
      A total of 30 patients were chosen, for a total of 120 restorations (30 for each group) after
      taking potential dropouts into account. To ensure adherence of the participants to the study,
      all volunteers underwent complete dental treatment and periodic follow-ups. The volunteers
      were contacted by telephone, WhatsApp message, Facebook, and e-mail for the assessments. Four
      attempts, including visits to the schools, were made to contact a volunteer before he/she was
      considered a "loss." both participants and examiners were blind to the interventions. An
      inter-examiner and intra-examiner agreement of at least 90% was requested before the
      beginning of the evaluation. Clinical evaluation was performed one week after finishing and
      polishing (baseline), after 6 months, 12 months, 18 months, and 24 months using the World
      Dental Federation (FDI) criteria.
    

Intervention name(s): Xtra-fill; x-base; Admira fusion x-tra; Admira fusion x-base
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): the material was placed in bulk.; The x-base liner was placed and then veneered with Xtra-fill.; bulk placement of the restoration Admira fusion -xtra.; Admira fusion x-base liner was used and then veneered by Admira fusion x-tra.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants had at least four class II cavities in a split-mouth design and randomly each cavity was restored using one of four strategies( groups applied)
Masking: Double (Participant, Investigator)
Primary purpose: Treatment