Here is the design of a clinical trial:

Official Title: Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial

Included conditions:
- Dental Caries

Study Armgroups:
- {'label': 'PapacarieMBlue and PDT', 'type': 'EXPERIMENTAL', 'description': 'Initial periapical and interproximal radiographs; Microbiological sample with otoscope curette to standardize volume of carious tissue; Application on PapacarieMBlue (addition of toluidine blue) for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with non-cutting curette; No removal of carious tissue on pulp floor; Irradiation of dental tissue for one minute on a single point; Second microbiological sample of remaining dentin with curette; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); Follow up: Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.', 'interventionNames': ['Drug: PapacarieMBlue and PDT', 'Device: Laser']}
- {'label': 'Toluidine Blue O and PDT', 'type': 'EXPERIMENTAL', 'description': 'Initial periapical and interproximal radiographs;Microbiological sample with otoscope curette to standardize volume of carious tissue;Application of Toluidine Blue O for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with sharp curette; No removal of carious tissue on pulp floor;non-cutting curette; Irradiation of dental tissue for one minute on a single point;Second microbiological sample of remaining dentin with curette; Follow up; Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.', 'interventionNames': ['Drug: Toluidine Blue O and PDT', 'Device: Laser']}

Interventions:
- {'type': 'DRUG', 'name': 'PapacarieMBlue and PDT', 'description': 'Initial periapical and interproximal radiographs Microbiological sample with otoscope curette to standardize volume of carious tissue; Application on PapacarieMBlue (addition of toluidine blue) for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with non-cutting curette; No removal of carious tissue on pulp floor; Irradiation of dental tissue for one minute on a single point; Second microbiological sample of remaining dentin with curette; Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.', 'armGroupLabels': ['PapacarieMBlue and PDT'], 'otherNames': ['Photodynamic therapy and lower level laser therapy']}
- {'type': 'DRUG', 'name': 'Toluidine Blue O and PDT', 'description': 'Initial periapical and interproximal radiographs;Microbiological sample with otoscope curette to standardize volume of carious tissue;Application of Toluidine Blue O for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with sharp curette; No removal of carious tissue on pulp floor;non-cutting curette; Irradiation of dental tissue for one minute on a single point;Second microbiological sample of remaining dentin with curette;Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE);Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.', 'armGroupLabels': ['Toluidine Blue O and PDT'], 'otherNames': ['Photodynamic therapy and lower level laser therapy']}
- {'type': 'DEVICE', 'name': 'Laser', 'armGroupLabels': ['PapacarieMBlue and PDT', 'Toluidine Blue O and PDT']}

Primary Outcomes:
- {'measure': 'Microbiological analysis - collection of dentinal tissue and restoration with glass ionomer cement', 'description': 'Based on a study by Guglielmi et al. (2011)(30) teeth with be selected (n = 48) and divided into three groups, as delineated in Chart 4. Fragments of dentinal tissue will be collected from all teeth before and after treatment for microbiological analysis. The teeth will be restored with glass ionomer cement in all cases.', 'timeFrame': '24 months'}

Please estimate the sample size based on the assumption: 
Paired samples, significance level (α) = 1.96 (5%), power (β) = 0.84 (20%), and 80% test power.
3.1.8
          Sample size
          The sample size will be calculated based on a previous study in the literature[30] (Fig. 1), considering the expected difference and standard deviation and weighting colony forming units (CFU) of bacteria. For the statistical calculation, paired samples were considered, with Î±â=â1.96 (5%); Î²â=â0.84 (20%), and an 80% test power. The minimum number in this clinical trial was determined to be 16 teeth per group (Fig. 2).
          
            Figure 1
            
              Sample size calculation used for this clinical research.
            
            
          
          
            Figure 2
            
              Determination of the sample size for this clinical research.