Dental Caries Extending Into Dentine Clinical Trial
Official title:
The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01749267 -
Digital Subtraction Radiography Evaluation of SMART Restoration With Partial Caries Removal in Primary Teeth
|
N/A |