The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations
Condition: Caries Involving Multiple Surfaces of Tooth; Dental Caries on Chewing Surface of Tooth; Dental Caries Extending Into Dentine
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate
      when used for the treatment of occlusal and proximal caries in primary molars with ART under
      field conditions.

      This research will be done under field conditions in Barueri, a city in the state of São
      Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months the
      restorations and teeth will be evaluated by two independent evaluators. Only children whose
      parent or representative who have signed an informed consent are included in this
      research.The ART treatments will be done by two dental students. The operators will receive
      the same ART-training. The children will be randomly assigned to one of the operators. The
      restorative material to be used in each child will be assigned by another random list. It
      will be performed descriptive analyses to describe the sample. Bivariate analyses will be
      performed to test the hypothesis. The data will be analyzed with a chi-square test to compare
      the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator
      effect, the influence of the cavity size on the survival rate, the position of the tooth, the
      dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative
      conditions. The effect of these variables on the survival rate will be evaluated using a
      regression analysis.
    

Detailed description: 
      The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate
      when used for the treatment of occlusal and proximal caries in primary molars with ART under
      field conditions.

      This research will be done under field conditions in Barueri, a city in the state of São
      Paulo, Brazil. A total of 600 patients will be selected, 300 patients with one occlusal carie
      lesion and 300 different patients with occlusal proximal cavities. After 1, 6, 12, 18 and 24
      months the restorations and teeth will be evaluated by two independent evaluators. Only
      children whose parent or representative who have signed an informed consent are included in
      this research. Only one restoration per child will be included in this study. If more carious
      lesions are present, one of them will be randomly selected for this research. The remaining
      carious lesions will be also be treated. The ART treatments will be done by two dental
      students. The operators will receive the same ART-training.

      The children will be randomly assigned to one of the operators. The restorative material to
      be used in each child will be assigned by another random list.

      The selected children can have or an occlusal (O) cavity or an occlusalproximal (OP) cavity.
      So, the stratum of the study is OP and O. So, one randomization list will be performed for
      occlusal cavities and another randomization list will be used for occlusal proximal cavities.

      It will be performed descriptive analyses to describe the sample. Bivariate analyses will be
      performed to test the hypothesis. The data will be analyzed with a chi-square test to compare
      the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator
      effect, the influence of the cavity size on the survival rate, the position of the tooth, the
      dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative
      conditions. The effect of these variables on the survival rate will be evaluated using a
      regression analysis.
    

Intervention name(s): GIC Restorations; Carbomer Restorations; Compomer Restorations
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Restorations using Glass Ionomer Cement; Restorations using Glass Carbomer; Restorations using Compomer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ART; Occlusal; Occlusoproximal; Primary teeth