Table 1 Flow diagram
Study period | ||||||
|---|---|---|---|---|---|---|
Selection visit | Randomization visit | Postrandomization visit | Emergency visit | |||
Time point | T-1 | T0 | T0 + 1 yr | T0 + 2 yrs | T0 + 3 yrs | Between T0 and T0 + 3 yrs |
Enrolment: | ||||||
- eligibility screen | X | |||||
- informed consent | X | |||||
- randomization | X | |||||
Interventions: | ||||||
- caries management | X | If needed | ||||
- X-ray | X | X | X | X | X | If needed |
Control of carious eviction with the SoproLife® | X | |||||
assessment: | ||||||
- baseline variables | X | X | ||||
- FDI criteria | X | X | X | X | ||
- other data variables listed in the CRF | X | X | X | X | ||