Here is the design of a clinical trial:

Official Title: Preformed Pediatric Crown Zirconia Versus Preformed Pediatric Metal Crown PPC Z-M

Included conditions:
- Tooth Decay

Study Armgroups:
- {'label': 'PPC m', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: PPC m']}
- {'label': 'PPC z', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: PPC z']}

Interventions:
- {'type': 'DEVICE', 'name': 'PPC z', 'description': 'Installation of a preformed pediatric zircona crown', 'armGroupLabels': ['PPC z']}
- {'type': 'DEVICE', 'name': 'PPC m', 'description': 'Installation of a preformed pediatric metal crown', 'armGroupLabels': ['PPC m']}

Primary Outcomes:
- {'measure': 'clinical and radiographique observations', 'description': 'Success of the treatment defined by the absence of major failure. A composite measure of signs and symptoms leading to diagnosis of irreversible pulpitis or periradicular periodontitis will be used to define major failure (pain, pulp infection, dental abscess, periradicular pathology visible on radiograph', 'timeFrame': '2 years'}

Please estimate the sample size based on the assumption: 
Alpha equal to 5%, 90% power, two one-sided test (TOST) Zα = 1.64, 80% power for equivalence test, dropout rate around 20%.
Sample size
        TableÂ 2 shows the sample size calculation for success rates ranging from 95% to 97%, alpha equal to 5%, with 90% power and an equivalence margin between the study groups of 10%. This table illustrates that the effective sample size of 81 teeth per treatment group will provide a power of 90% to assess effectiveness equivalence between the treatment groups. These rates were based on the systematic review of Innes et al. [3]. This calculation was based on the formula (Z 0.95â+âZ 0.90)2 [Ps (1 â Ps)â+âPn (1 â Pn)] / (Ps â Pn â D)2 (see http://people.ucalgary.ca/~patten/blackwelder.html) [14].
Table 2Sample size calculationRateTeethTotal required8027454885218438901543089581162974998Note: Rate of the outcome for the study groups, powerâ=â90%, alphaâ=â5%, equivalence marginâ=â10%
        Additionally, when we consider a hazard ratio (HR)â=â1, moderate intraclass correlation (ICC) = 0.05, the percentage of teeth in each study group of 50%, the probability of observing an event of 90%, and two one-sided test (TOST) ZÎ± = 1.64, this sample size of 81 teeth provides 80% power to test the equivalence between the study groups for margins ranging from 0.7 to 0.9. This sample size was calculated as described in [15].
        Furthermore, assuming a dropout around 20%, the total sample size necessary will be 101 children. This dropout value was based on the experience of the research team from previous RCTs conducted in France [16]. This sample size is higher than those of past RCTs assessing the effectiveness of esthetic PPCs, which included 11 to 60 teeth per treatment group [6, 7].