Here is the design of a clinical trial:

Official Title: Efficiency of Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Dental Patients

Included conditions:
- Dental Caries
- Dental Anxiety
- Behavior

Study Armgroups:
- {'label': 'Er:YAG laser therapy', 'type': 'EXPERIMENTAL', 'description': 'Er:YAG laser will be used for enamel conditioning of the occlusal surfaces of the permanent molars before sealant application as well as the standardized caries treatment.', 'interventionNames': ['Procedure: Laser conditioning and Sealant application', 'Device: Er:YAG laser therapy']}
- {'label': 'Conventional therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Conventional rotary instruments will be used for caries treatment.', 'interventionNames': ['Procedure: Sealant application', 'Procedure: Conventional therapy']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Laser conditioning and Sealant application', 'description': 'Sealant application protocol includes: a low-speed rubber cup and pumice paste (CleanPolish, Kerr) will be used for 30 seconds for cleaning and polishing of the occlusal surface of the chosen permanent molar; tooth surface will be washed for debris and organic residue removal and dried with air spray; isolation; laser conditioning of the occlusal enamel surface. The parameter settings used will be: tip-to-tissue distance 1.5mm from the tooth surface; tip diameter 600 µm; laser energy 70 mJ; pulse frequency 10 Hz; water spray level 8; average power 0.7 W; energy density 67 J/cm2; tooth surface will be etched with 35% phosphoric acid gel (Etching gel, DMP Ltd) for 30 seconds and rinsed for the same time; reisolation; tooth surface will be dried with air spray for 15s; fissure sealant application (Pit\\&Fissure Sealant, DMP Ltd); light cured for 20 seconds.', 'armGroupLabels': ['Er:YAG laser therapy']}
- {'type': 'PROCEDURE', 'name': 'Sealant application', 'description': 'Sealant application protocol includes: a low-speed rubber cup and pumice paste (CleanPolish, Kerr) will be used for 30 seconds for cleaning and polishing of the occlusal surface of the chosen permanent molar; tooth surface will be washed for debris and organic residue removal and dried with air spray; isolation; tooth surface will be etched with 35% phosphoric acid gel (Etching gel, DMP Ltd) for 30 seconds and rinsed for the same time; reisolation; tooth surface will be dried with air spray for 15s; fissure sealant application (Pit\\&Fissure Sealant, DMP Ltd); light cured for 20 seconds.', 'armGroupLabels': ['Conventional therapy']}
- {'type': 'DEVICE', 'name': 'Er:YAG laser therapy', 'description': 'Er:YAG laser (LiteTouch, Light Instruments LTD), emission wavelength 2940 nm will be used for caries removal - parameters: enamel removal - energy 100-200mJ; density 9.84-13.03 J/cm2, pulse frequency 20Hz; tip diameter 800 μm; water spray level 8; tip-to-tissue distance 0.5÷1 mm form the tooth surface; dentin removal - energy 100mJ; density 9.84 J/cm2, pulse frequency 20Hz; tip diameter 800 μm; water spray level 8; tip-to-tissue distance 0.5÷1 mm form the tooth surface. Restoration with compomer.', 'armGroupLabels': ['Er:YAG laser therapy']}
- {'type': 'PROCEDURE', 'name': 'Conventional therapy', 'description': 'Conventional rotary instruments will be used for caries removal - high-speed and low-speed dental handpieces. Restoration with compomer.', 'armGroupLabels': ['Conventional therapy']}

Primary Outcomes:
- {'measure': 'self-report dental anxiety on a modified version of the self-report Faces Scale by LeBaron', 'description': "The scale comprises a row of five faces ranging from 'relaxed' to 'very worried' in combination with a visual analog scale of 0 - 10. Each child was asked to point to the face or choose the number which most closely depicted its state of anxiety.", 'timeFrame': 'Immediately after the dental treatment'}

Please estimate the sample size based on the assumption: 
The sample size calculation assumes a test power greater than 95% and a significance level of α = 0.05.
Sample size calculation
          The sample size calculation is performed based on data from a pilot study with 20 subjects. To estimate sample size for the primary outcomeâself-reported anxiety felt, according to the Faces Scale by LeBaronâa t-test for paired groups has been used (G* Power software V.3.1,6 since we have two groups). The effect size was determined using the formula
          ES=ControlâTreatedSDpooled=2.33â0.333.25=0.62,
          where SD is the pooled SD, an average of the SD of the experimental and control groups. The sample size is calculated to assure a test power greater than 95% and a significant level of Î±=0.05. We estimated a sample size of 41 patients per group to detect significant differences. Thus, the final sample size for this study will be 82 patients.