Here is the design of a clinical trial:

Official Title: Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic

Included conditions:
- Dental Caries in Children
- Dental Diseases

Study Armgroups:
- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'In the intervention group there will be the application of the intervention - use of telemonitoring and teleorientation applied to children in primary care in Dentistry.', 'interventionNames': ['Other: Telemonitoring and teleorientation']}
- {'label': 'Waiting list', 'type': 'ACTIVE_COMPARATOR', 'description': "In the control group, children waiting to be booked to the intervention (in implementation in the unit because of the pandemic) will be evaluated for the outcomes. Only after the evaluation, the control group's children will be invited to perform the teleconsultation (proposed intervention).", 'interventionNames': ['Other: Control Group - Waiting list']}

Interventions:
- {'type': 'OTHER', 'name': 'Telemonitoring and teleorientation', 'description': 'Teleservice will be performed through a digital platform (Video for Health" - V4H). The service will consist of: a) recognition of the condition identified in the pandemic period, including updates on medical history, current oral health condition, search for dental care in other units, need for referral, change of hygiene habits, b) realization of diet guidance, hygiene and other necessary habits, made from a situational recognition of such habits, c) targeting the needs presented, in which individualized counselling will be given seeking to meet the demand presented by that family nucleus. A dental form developed on the digital platform Google Forms will serve as a guide for the performance of the service and where the collected data will be formally recorded. The guidelines, although individualized for the needs of each child, will follow a pre-defined and standardized structure and based on the best evidence available in the subject.', 'armGroupLabels': ['Intervention']}
- {'type': 'OTHER', 'name': 'Control Group - Waiting list', 'description': 'No intervention (at least, until the time frame for outcome assessment)', 'armGroupLabels': ['Waiting list']}

Primary Outcomes:
- {'measure': 'Family/patient´s perception about the dental care', 'description': 'Evaluation of the quality of dental care to be measured by the SERVQUAL questionnaire (a multi-dimensional research instrument) - total of 22 items and 5 dimensions, comprising 4 items to capture tangibles, 5 items to capture reliability, 4 items for responsiveness, 4 items for assurance and 5 items to capture empathy.\n\nA total of 100 points is allocated among the five dimensions. The participants evaluate the degree to which they perceived the proposed service. To identify participants\' perceptions, one item asked, "How do you feel about these service attributes that are already provided?", which was scored on a 5-point Likert-type scale of "very bad (1)" to "very good (5)."', 'timeFrame': '2 weeks after intervention (or one week of waiting - in the case of the control group)'}

Please estimate the sample size based on the assumption: 
A more conservative calculation was used, and an extra 20% was added to compensate for possible losses.
Sample size and recruitment
          The sample calculation was made using the application sample-size.net and considered the primary outcome for the RCT as a reference. As more than one dimension is considered in evaluating the primary outcome, we consider an average between them. A hypothetical user's difference between the perceived and the expected users' quality appraisal related to a regular health service clinic [27] was used to estimate a minimum difference for this trial, aiming at a more conservative calculation. The minimum difference expected was set, then, as 0,17 (effect size) and a standard deviation of 0,53 assumed (based on the worst case scenario in the referred study) [27]. A minimum sample of 306 users or family representatives in the RCT was estimated. Extra 20% was added to compensate for possible losses, resulting in a final sample of 368 families recruited. Thus, the first 368 families from the unit's care list will be included (randomized). To reach the required number of children, all participants registered at the mobile dental care unit will be invited to participate in this study by telephoneÂ or social media contact or message, as detailed in the before-and-after study.