School of Dentistry - Sao Paulo University
São Paulo, 05508-000, Brazil
NCT Number: NCT02217098
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.
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Notify Me4 year–8 year
All sexes
Interventional
Not applicable
São Paulo, 05508-000, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for the patient:
Inclusion criteria
for the tooth:
Exclusion criteria
Restorations using Glass Ionomer Cement
Restorations using Glass Carbomer
Restorations using Compomer
Time frame: 6, 12, 24 and 36 months follow-up
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 occlusoproximal caries in primary molars with ART under field conditions.
Time frame: 6, 12, 24 and 36 months follow-up
Time frame: 6, 12, 24 and 36 months follow-up
Time frame: 6, 12, 24 and 36 months follow-up
Time frame: 6, 12, 24 and 36 months follow-up
Time frame: 6, 12, 24 and 36 months follow-up
Time frame: 6, 12, 24 and 36 months follow-up
Daniela Prócida Raggio
Other
Acronym: ARTUSP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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