Minimally Invasive Restorations in Primary Molars Using Encapsulated ou Hand-mixed Glass Ionomer Cement: Clinical Trial With 24 Months of Follow-up

Detailed Description: This study was approved by the research ethics committee of the School of Dentistry (University of São Paulo, Brazil) and written informed consent will be obtained from the parents or legal guardians. The sample size was calculated based on the data obtained in a systematic review, which reported average longevity of 78% after 2 years of follow up (mean survival of occlusal and occlusoproximal surfaces). The minimum difference of 15% in the success rate between the control and treatment groups after 2 years of follow-up, with and α of 5% and power (strength) of 80% using paired test. As more than one tooth per children might be included, we must add a 20% for clustering. Adding 20% for possible losses the final estimate is 116 teeth per group, reaching a final sample of 232 teeth.

Inclusion Criteria:

• Children who have sought treatment in the School of Dentistry, University of Sao Paulo;
• Children between 3 and 10 years old without systemic diseases;
• Children presenting at least one dentin caries cavity in primary teeth (occlusal or oclusoproximal) with no signs of pulp involvement.

Exclusion Criteria:

• Children whose parents did not agree to participate in the study;
• Children with behavioural issues at the initial exam or who did not assent to participate in the study.