Here is the design of a clinical trial:

Official Title: CARies DEtection in Children-Pelotas (CARDEC-PEL): Comparison of Two Methods of Caries Risk Assessment in Children

Included conditions:
- Caries,Dental

Study Armgroups:
- {'label': 'Multivariate risk assessment group (ICCMS®)', 'type': 'EXPERIMENTAL', 'description': 'Multivariate risk assessment group (ICCMS®): multivariate caries risk assessment based on International Caries Classification and Management System (ICCMS™) guide', 'interventionNames': ['Diagnostic Test: ICCMS']}
- {'label': 'Simplified risk assessment group (dental caries experience)', 'type': 'EXPERIMENTAL', 'description': 'Simplified risk assessment group (dental caries experience): simplified caries risk assessment based on dental caries experience (WHO criteria)', 'interventionNames': ['Diagnostic Test: ICCMS']}

Interventions:
- {'type': 'DIAGNOSTIC_TEST', 'name': 'ICCMS', 'description': 'Risk caries assessment will consider ICCMS criteria', 'armGroupLabels': ['Multivariate risk assessment group (ICCMS®)', 'Simplified risk assessment group (dental caries experience)']}

Primary Outcomes:
- {'measure': 'New caries lesions', 'description': 'Incremental number of dental surfaces with operative treatment needs. This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the treatment plan.', 'timeFrame': 'from baseline (first measurement) to 24months'}

Please estimate the sample size based on the assumption: 
A significance level of 0.05 and a power of 0.80 were used, with a two-tailed test. A sample loss of 20% was also considered.
Sample size
        The sample estimation was based on the primary outcome, which is the number of tooth surfaces in need of surgery during follow-up. Therefore, the following possibilities were considered to compose this outcome:New caries lesions;Restorations in need of replacement;Dental extractions (5 surfaces per tooth);Resolution of pain episodes and/or need for endodontic treatment (5 surfaces per tooth).
        To perform the sample calculation, incidence data were collected for all possibilities in the literature, reaching an average occurrence of 17.6 new decayed surfaces in 2Â years [22], 10% failure of occlusal-proximal and composite resin and glass ionomer occlusal restorations, which gives an average of 0.1 surface with the need to change for occlusal restorations and 0.2 surfaces in 2Â years [23], 0.08 tooth extractions for caries in two years, totaling 0.2 surfaces [24] and 0.2 pain episodes in 2Â years on average, leading to an average of 1 surface treated in 2Â years. Thus, the estimate of surfaces in need of surgical treatment in 2Â years is an average of 19. It was considered that the reduction of 5 surfaces in need of treatment would be a significant number. The expected mean for the test group would be 14. The expected standard deviation values for the control and test groups are 15 and 10, respectively [22â24]. Considering a significance level of 0.05 and a power of 0.80, using a two-tailed test, the minimum number of children per group calculated was 103. Considering a sample loss of 20%, the final rounded number required of 250 children was reached.