Evaluation of Glass Ionomer Cement Modified With Chlorhexidine and Titanium Dioxide in Primary Molars (RCT)
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      to investigate the effect of modifying GIC with different formulations on the antibacterial
      activity and clinical performance in reference to unmodified glass ionomer restorative
      materials.
    

Detailed description: 
      The study will be a randomized clinical trial, with a 1:1:1 allocation ratio and parallel
      arms that will enroll children from the outpatient clinic of pediatric dentistry department,
      Ain shams University Blinding: Enrolled children, assessors and statistician will be blinded.
      Randomization: block randomization with blocks of 6. A maximum of 2 primary molars per
      patient will receive the same treatment.

      Allocation concealment: Allocation will be done just before placement of a restoration to
      avoid performance bias during the cavity preparation. The envelope will be only checked after
      cavity preparation when the filling material will be chosen

      Groups Teeth will be randomly allocated to 3 groups all groups will receive the same cavity
      preparation and then a different restoration.

        -  Group A: glass ionomer powder will be mixed with chlorhexidine

        -  Group B: glass ionomer will be mixed with titanium dioxide powder.

        -  Group C: will be the positive control, glass ionomer with no additives

      Sample Size The sample size: A total number is 39 (13 in each group) is calculated using
      Epicalc program version 1.02 assuming a power of 80 % and alpha=0.05. The sample size is
      based on percentage of success of ART restorations at 9 months follow up (GIC with
      chlorhexidine and GIC with miswak) was 60% and 90%, respectively.13

      Intervention:

      Teeth will be randomly allocated to the three groups. Care givers and patients involved will
      be informed about the study procedures, an informed consent form and assent will be obtained.
      Group A: Conventional glass ionomer cement (Fuji IX, GC, Tokyo, Japan) will be used and
      modified by incorporating CHX diacetate (0.5% wt) into the powder of the glass ionomer (Fuji
      IX, GC, Tokyo, Japan) Group B: Conventional glass ionomer cement (Fuji IX, GC, Tokyo, Japan)
      will be used and modified by incorporating titanium dioxide (3% wt) in glass-based powder
      component of the GIC.

      Group C: Conventional glass ionomer

      Cavity preparation and baseline sampling Rubber dam will be placed for isolation of the
      designated teeth. A step wise caries removal technique will be employed28. Access to the
      cavity was created using a high-speed dental handpiece fitted with a Meisinger (Hager &
      Meisinger - Germany) round diamond bur (801G-16) , and all the caries on the lateral walls,
      caries in the dentine-enamel junction and undermined enamel was removed.

      Using a discoid Lascod (Lascod S.p.A Italy) excavator (#1) elective removal of superficial
      soft necrotic dentine was attempted, leaving behind demineralized wet, leathery dentine
      centrally on the pulpal wall (Leathery dentine is characterized by being removed in flakes by
      the excavator) 8,27 A different sterile excavator of the size will be used with very light
      pressure to take a sample of dentine from the center of the cavity floor center, the sample
      will be inserted in a brain heart infusion tube and sent to the microbiology lab within 1
      hour then added to the culture to measure the bacterial load for the baseline sample by
      measuring the colony forming units (CFU) 29,30. Blood agar will be used to quantify the total
      bacterial count, while mitis-salivaris -bacitracin agar will be used to selectively quantify
      S.mutans.

      After cavity preparation, an endodontic file will be used to record the depth of the cavity
      to aid with the re-entry, and then the operator will reveal the patient's group by opening an
      envelope. GC cavity conditioner" (GC Japan) will be applied to the cavity walls for 20
      seconds leaving the floor unconditioned then the material will be packed into the cavity
      using a ball burnisher and pressed into it with a petroleum jelly covered gloves for 30 s
      (press finger technique). Then the excess material will be removed using a carver, and
      occlusion will be checked and adjusted, then Equia coat varnish (GC Japan) will be applied.

      Follow-up The patients will be recalled at 6 and 9 months for clinical performance evaluation
      by the USPHS evaluation criteria (table 1). Visual and clinical inspection with 3.5x
      magnification will be done with the help of a sharp explorer by a blinded secondary
      investigator.
    

Intervention name(s): glass ionomer-chlorhexidine; glass ionomer-titanium dioxide powder; glass ionomer
Intervention type(s): Other; Other; Other
Intervention description(s): chlorhexidine will be added to glass ionomer; titanium dioxide will be added to glass ionomer; glass ionomer will be used without any additives
Intervention MeSH terms: Chlorhexidine; Methamphetamine; Titanium dioxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment