Glass-ionomer Cement Containing Chlorhexidine for ART
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study evaluated the clinical and microbiological long-term effects of 1.25% CHX
      associated with GIC applied in primary molars using Atraumatic Restorative Treatment (ART)
      technique. Randomized controlled trial was conducted on 40 children with carious lesions that
      received ART either with GIC containing CHX or GIC only. Survival rate of restorations was
      checked at 3 days, 3 months and 1 year after their placement when the unstimulated saliva
      samples were collected for microbiological assessment of mutans streptococci (MS) counts.
      Data were analyzed using ANOVA/Tukey or Kruskal-Wallis/Mann-Whitney tests (p <0.05).
    

Detailed description: 
      ART treatment and follow-up:

      Carious lesions were prepared by removing infected dentin with hand instruments. No local
      anesthesia was administered. Then, the cavities were filled with the press finger technique
      with one of the randomly selected materials: (1) GIC KetacMolar Easymix® containing 1.25%
      chlorhexidine digluconate (KM + CHX; n= 41 tooth surfaces) or (2) KetacMolar Easymix® as a
      control group (KM; n = 66 tooth surfaces). Material excess was removed using carver
      instrument and the restoration was coated with a layer of petroleum jelly. Multiple-surface
      cavities were filled after placement of plastic bands and wedges. Both molars (class I and
      II) and incisors were treated in this study and the same GIC were used for patients who had
      more than one carious teeth indicated to ART. The children underwent longitudinal clinical
      follow-up to assess physical condition (partial or complete fractures) of the restoration and
      the presence of primary or secondary caries at 7 days, 3 months and 1 year, according to ART
      evaluation criteria by Frencken et al. Children were encouraged and instructed on dental
      hygiene and received all other necessary oral care.

      Microbiological assays:

      Unstimulated whole saliva was collected after 7 days, 3 months and 1 year after treatment
      from each subject by direct expectoration into a 50-ml sterile container for 5-10 min. Pooled
      supragingival biofilm samples were collected from all buccal and lingual smooth surfaces,
      except from the interior of the cavities. In order to standardize plaque amount, a sterile
      plastic disposable inoculating loop with a circular opening of about 1 µL capacity was used
      for the collection. Collection was stopped when the opening was filled. Biofilm samples were
      placed immediately into a 1-ml centrifuge microtubes containing Tris-EDTA buffer (10 mM
      Tris-Hcl, 0.1 mM EDTA, pH 7.5). Collections were performed at least 1 h after feeding. Tubes
      were transported on ice to laboratory and processed within 2 h.
    

Intervention name(s): ART with GIC containing 1.25% CHX.; ART with GIC.
Intervention type(s): Procedure; Procedure
Intervention description(s): Carious lesions were prepared by removing infected dentin with hand instruments. No local anesthesia was administered. Then, the cavities were filled with the press finger technique using GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (n= 41 tooth surfaces).; Carious lesions were prepared by removing infected dentin with hand instruments. No local anesthesia was administered. Then, the cavities were filled with the press finger technique using KetacMolar Easymix® (n = 66 tooth surfaces).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dental caries; glass ionomer cement; ART