Clinical Performance of BIS-GMA Free Dental Resin Composite
Condition: Therapeutics
Study type: Interventional

Summary: 
      Resin composites were introduced for restoring defective teeth commercially in the mid- 1960s
      as an alternative to acrylic resin and silicate cements. As one of the most signiﬁcant
      contributions to dentistry, dental resin composites usually have three components as organic
      resin matrix, photo initiator system, and coupling agent treated inorganic ﬁllers.

      At present, the most commonly used organic resin matrix for dental resin composites are based
      on di-methacrrylates such as 2.2- bis [p-(2- hydroxy-3- methacryloxypropoxy) penylene]
      propane (Bis-GMA), ethoxylated bisGMA,
      1,6-bis(2-methacryloyoxy-ethoxycarbonyl-amino)-2,4,4tri-methyl-hexane (UDMA) and
      triethyleneglycoldimethacrylate (TEGDMA).

      The application of Bis-GMA has been doubted since it was reported to have estrogenic activity
      in a cell culture assay.Though later studies have showed that Bis-GMA does not hydrolyse into
      the estrogenic substance BPA, BPA has still been detected to be release out of several
      commercial Bis-GMA-based dental restorative materials. Although there is a lack of studies
      analysing the association between BPA exposure from dental materials and its adverse effects
      on human health, there is a need to develop newer BPA-free resin composites to minimize human
      exposure to this compound. Accordingly, the objective of this study was to evaluate the
      performance of BIS- GMA- free composite as a photopolymerizable posterior dental composite
      restoration.
    

Detailed description: 
      Hypothesis: The null hypothesis is that there is no difference in using the new BIS- GMA-
      free composite.

      Aim of the study: This clinical trial was conducted to compare the clinical performance of
      the new BIS- GMA- free composite versus BIS-GMA- containing composite in the management of
      carious lesion in adult patients over 9 months. The two types of composites will be evaluated
      using USPHS criteria for:

        -  Retention (R).

        -  Contact (C).

        -  Color match (CM).

        -  Marginal adaptation (MA).

        -  Marginal discoloration (MD).

        -  Anatomic form (AF).

        -  Secondary caries (SC).

        -  Surface texture (ST).

        -  Gingival inflammation (GI).

        -  Post-operative sensitivity (POS).

        -  Patient complaints (PC).

        -  Patient satisfaction (PS).

        -  The evaluation done by three calibrated operators.

      The study was conducted in Operative Dentistry Department, Faculty of Dentistry, Menia
      University.

      The researcher was bear ultimate responsibility for all activities associated with the
      conduct of a research project including recruitment of patients, explaining, and performing
      the procedures to them.

      - Intervention:

      BIS- GMA- free composite material:

      Tooth preparation and restoration was carried out using magnifying loops. All cavities were
      restored using composite resin. cavities, including the dentin, were acid etched for 30 s,
      rinsed thoroughly for 15 s, bonded with universal adhesive and light cured for 10 s prior to
      placing the filling material.

      Restorations were light cured for 20 s, check the occlusion, finished with diamond burs and
      polished with Kenda hybrid composite pre- and super-polishers (Kenda, Vaduz, Liechtenstein).

      - Comparator:

      BIS- GMA- containing composite material:

      The same methodology of the intervention BIS-GMA- free composite material If the patient
      showed any complications during our clinical trial toward either the intervention (BIS- GMA-
      free composite) or the comparator (BIS-GMA containing composite material), the trial will be
      stopped at once and all the needed management against any complications will be done.
    

Intervention name(s): Bis-GMA Free dental resin composite
Intervention type(s): Other
Intervention description(s): Restorative Material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bis-GMA free dental resin composite; Bis-GMA containing dental resin composite; Clinical performance; Modified US Public Health Service Clinical Criteria (USPHS)