Table 1 Trial procedures by visit
Visit | Procedures to be performed |
|---|---|
Screening | Complete process for written informed consent with resident or legal representative (including mental capacity assessment) |
Gather demographic information | |
Complete medical history | |
Review concomitant medications | |
Brief oral examination | |
Eligibility assessment | |
Baseline examination (within 28 days of screening) | Changes to mental capacity |
Examination using ICDAS root caries scoring system undertaken by blinded assessor | |
Review concomitant medications | |
Adverse event monitoring | |
Undertake in depth interviews with residents to consider acceptability, QoL (OIDP and EQ5D5L and EQ5D3L survey tool) and relative need (IoRN2) | |
Compliance check | |
IMP administration | |
Reissue 1450 ppm fluoride toothpaste to Arm1 and Arm 3 and 2800 ppm to Arm 2 | |
Placement of fluoride varnish by trained hygienist to Arm 3 | |
Complete qualitative interviews with organisational teams | |
Brushing charts to be issued | |
Collect health care use data for year preceding and intervention year | |
Collect resource costs data from the care home | |
Completion of data collection forms for resource cost data from the care home/ dental team | |
Randomisation | Randomisation of homes within 7 days of last baseline visit |
3 months from baseline (± 3 days) | Assess changes to mental capacity |
Review concomitant medications | |
Adverse event monitoring | |
Administer QoL (OIDP and EQ5D survey tools) and relative need (IoRN2) | |
IMP administration | |
Reissue 1450 ppm fluoride toothpaste to Arm1 and Arm 3 | |
Reissue 2800 ppm fluoride toothpaste to Arm 2 | |
Placement of fluoride varnish by trained hygienist to Arm 3 | |
Brushing charts to be issued | |
6 months from baseline (± 3 days) | Assess changes to mental capacity |
Examination using ICDAS root caries scoring system undertaken by blinded assessor | |
Undertake in depth interviews with residents to consider acceptability, QoL (OIDP and EQ5D survey tools) and relative need (IoRN2) | |
Compliance check | |
Review concomitant medications | |
Adverse event monitoring | |
IMP administration | |
Reissue 1450 ppm fluoride toothpaste to Arm1 and Arm 3 | |
Reissue 2800 ppm fluoride toothpaste to Arm 2 | |
Placement of fluoride varnish by trained hygienist to Arm 3 | |
Brushing charts to be issued | |
Collect health care use data for year preceding and intervention year | |
Collect resource costs data from the care home | |
Completion of data collection forms for resource cost data from the care home/ dental team | |
9 months from baseline (± 3 days) | Assess changes to mental capacity |
Review concomitant medications | |
Adverse event monitoring | |
Compliance check | |
Administer QoL (OIDP and EQ5D survey tools) and relative need (IoRN2) | |
IMP administration: | |
Reissue fluoride toothpastes to control and one intervention arm | |
Placement of fluoride varnish by trained hygienist to one arm | |
Brushing charts to be issued | |
12 months from baseline (± 3 days) (end of trial) | Assess changes to mental capacity |
Examination using ICDAS root caries scoring system undertaken by blinded assessor | |
Compliance check | |
Review concomitant medications | |
Adverse event monitoring | |
Undertake in depth interviews with residents to consider acceptability, QoL (OIDP and EQ5D survey tools) and relative need (IoRN2) | |
Complete qualitative interviews with organisational teams | |
Collect health care use data for year preceding and intervention year | |
Collect resource costs data from the care home | |
Completion of data collection forms for resource cost data from the care home/ dental team |