Table 1.
FiCTION Trial: Schedule of outcome data collection events
| Event | Completed by: | Baseline examination appointment | Treatment appointments (Scheduled treatment or recall & unscheduled/ emergency) | Final appointment at 3 years post randomisation |
|---|---|---|---|---|
| Bitewing Radiographs |
GDP |
Risk-based in line with guidance |
||
| |
|
NOT A STUDY INVESTIGATION |
||
| Consent/Assent & Randomisaton |
GDP |
X |
|
|
| ICDAS (CRF) |
GDP |
X |
|
X |
| Adverse Event recording (CRF) |
GDP |
|
X |
X |
| Pain: post treatment questions to GDP (CRF) |
GDP |
|
X |
X |
| Cooperation (CRF) |
GDP |
|
X |
X |
| Intervention Cost data (CRF) |
GDP |
|
X |
X |
| Discomfort during treatment (DDQ8) |
Parent |
|
X |
X |
| Quality of Life |
Parent |
X |
|
X |
| Worry and Pain pre/post treatment questions to parent |
Parent |
|
X |
X |
| Economic questions |
Parent |
|
X |
X |
| MCDAS & worry |
Child |
X |
X |
X |
| Pain: pre/post treatment questions to child: VAS | Child | X | X | |