Here is the design of a clinical trial:

Official Title: Caries Inhibition With CO2-Laser During Orthodontic Treatment

Included conditions:
- Caries; Initial

Study Armgroups:
- {'label': 'Fluoride and Laser', 'type': 'EXPERIMENTAL', 'description': 'In the split-mouth design, the left maxillary anterior teeth receive topical fluoride application and carbon dioxide (CO2) laser irradiation.', 'interventionNames': ['Procedure: Topical fluoride application and Laser irradiation']}
- {'label': 'Fluoride', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the split-mouth design, this arm - the contralateral teeth (right maxillary incisors), will receive topical fluoride application.', 'interventionNames': ['Procedure: Topical fluoride application']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Topical fluoride application and Laser irradiation', 'description': 'Topical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth followed by laser irradiation with CO2-laser (Ultra Dream Pulse, DS_40U, Daeshin Enterprise, Seoul, South Korea), emission wavelength 10,600 nm, time on-100 μs, time off-40 ms; average power-0.73 W; peak power-292.73 W; speed of movement-2 mm/s; energy density with movements-5 J/cm2; tip-to-tissue distance-20 mm; tip diameter 700 μm; irradiation time-30 s.', 'armGroupLabels': ['Fluoride and Laser']}
- {'type': 'PROCEDURE', 'name': 'Topical fluoride application', 'description': 'Topical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth', 'armGroupLabels': ['Fluoride']}

Primary Outcomes:
- {'measure': 'Changes into International Caries Detection and Assessment System (ICDAS) codes', 'description': "The International Caries and Detection System (ICDAS) is a visual scoring system developed for use in clinical assessment and clinical research of caries development and progression. It uses a numbered scoring system with a range from 0 to 6, to grade enamel demineralization and cavitation. Code of '0' represents unaffected/sound enamel, no caries change, '1' - first visual change, represents initial demineralization that is visible only after air drying, '2' represents a distinct visual change in the enamel that is visible when the surface is wet, '3' represents localized enamel loss or breakdown, no visible dentin or underlying shadow, and '4-6' represent larger carious lesions in dentin.", 'timeFrame': '1 year'}

Please estimate the sample size based on the assumption: 
Significance level of 95% and power of 80%
Sample size calculation
          The sample size calculation is based on our primary outcome endpoint of changes in ICDAS score on the vestibular surfaces of the anterior maxillary teeth in the left and the right quadrants per subject, by comparing the proportion of teeth with worsening ICDAS score in experimental in comparison to the control group. To determine the sample size for each group, a priori power analysis was conducted as follows:
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				\begin{document}$$ n=\frac{\left(z\frac{\upalpha}{2}+\mathrm{z}\upbeta \right)2\left(p1\left(1-p1\right)+p2\ \left(1-p2\ \right)\right)}{\begin{array}{c}\left(p1-p2\right)2\\ {}\end{array}} $$\end{document}n=zÎ±2+zÎ²2p11âp1+p21âp2p1âp22
          p1: 8.7% of the lesion incidence in the control group
          p2: 3.6% of the lesion incidence in the laser group
          The data for this power analysis were obtained from a previous study.9 The significance level was considered as 95% and power was 80%. By inserting the minimum values in the above formula, the sample size was calculated as 241 teeth (121 teeth per group, i.e., a total number of 41 patients).