Table 1 FiCTION Trial: Schedule of outcome data collection events
From: The FiCTION dental trial protocol – filling children’s teeth: indicated or not?
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 | |