Sealing of Occlusal Dentin Caries in Primary Molars.
Condition: Caries; Dentin; Fissure, Dental; Dental Caries in Children; Glass Ionomer Cement; Fissure Sealants
MeSH terms: Dental Caries; Dental Fissures
Study type: Interventional

Summary: 
      BACKGROUND A simple method for arresting dentin caries with a tight seal of the cavity would
      exclude the need for injection and excavation, reduce the risk for dental fear and possibly
      postpone or eliminate the need for further treatment.

      AIM The aim is to evaluate success-rate and children's subjective experience of resin-based
      sealing (RBS) and resin-modified glass ionomer cement (GIC) for treatment of occlusal dentin
      caries in primary molars.

      DESIGN Children aged 2-9 years will be recruited to undergo RBS- or GIC-treatment treatment
      for occlusal dentin caries in primary molars. A parent will answer the Short Form of
      Children's Fear Survey (CFSS-DS; parental version). No excavation but etching with 38%
      phosphoric acid will precede RBS. Topical and local anaesthesia and excavation with high
      speed bur will precede GIC. Time for treatment will be estimated. The children will rank
      their experience of each treatment on a 7-grade face scale. The dentist will evaluate the
      child's experience, cooperation and the overall experience of the treatment on a four-grade
      scale. The treatment will be evaluated as "without remark" or "defective" after 3, 6, 12, 24
      and 36 months. For statistical analysis the Chi-2-test, Wilcoxon-Signed-Rank-test and Paired
      t-test will be used.
    

Detailed description: 
      BACKGROUND A simple method for arresting dentin caries with a tight seal of the cavity would
      exclude the need for injection and excavation, reduce the risk for dental fear and possibly
      postpone or eliminate the need for further treatment.

      AIM The aim is to evaluate success-rate and children's subjective experience of resin-based
      sealing (RBS) and resin-modified glass ionomer cement (GIC) for treatment of occlusal dentin
      caries in primary molars.

      DESIGN Up to 300 children aged 2-9 years will be recruited to undergo RBS- or GIC-treatment
      treatment for occlusal dentin caries in primary molars. A parent will answer the Short Form
      of Children's Fear Survey (CFSS-DS; parental version). No excavation but etching with 38%
      phosphoric acid will precede RBS. Topical and local anaesthesia and excavation with high
      speed bur will precede GIC. Time for treatment will be estimated. The children will rank
      their experience of each treatment on a 7-grade face scale. The dentist will evaluate the
      child's experience, cooperation and the overall experience of the treatment on a four-grade
      scale. The treatment will be evaluated as "without remark" or "defective" after 3, 6, 12, 24
      and 36 months. For statistical analysis the Chi-2-test, Wilcoxon-Signed-Rank-test and Paired
      t-test will be used.
    

Intervention name(s): Resin based sealing [RBS]
Intervention type(s): Procedure
Other intervention name(s): Glassionomer cement [GIC].
Intervention model: Single Group Assignment
Intervention model description: Non-blinded randomized split-mouth longitudinal 3 year follow up study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fissure sealant; dental atraumatic restorative treatment; deciduous teeth; glass ionomer cement; Dental Caries in Children