Table 1.
Summary of study measures and timeline in the older adults trial.
| Variable type, measure, and scale | Source | Timeline | ||
| Intervention by study arms |
|
T0a, T26b | ||
|
|
Arm 1: Biannual SDFc |
|
|
|
|
|
Arm 2: ARTd + biannual FVe |
|
|
|
| Primary outcome |
|
|
||
|
|
Clinical dental examination |
|
T0, T26, T52f | |
|
|
Caries arrest, frequency of treated surface/teeth that are arrested (%) | ICDASg coronal and root [30] |
|
|
| Self-reported evaluation |
|
T0, T26, T52 | ||
|
|
Tooth pain/sensitivity, overall score | PROMIS version 1.0 – Pain Intensity 3a (Modified for dental) [32] and Dental Discomfort Questionnaire (Modified for adults from [33]) |
|
|
| Secondary outcomes |
|
|
||
|
|
Clinical dental examination |
|
T0, T26, T52 | |
|
|
New decay, frequency of new decayed surface/teeth (%) | ICDAS coronal and root [30] |
|
|
| Self-reported evaluation |
|
T0, T26, T52 | ||
|
|
Oral health quality of life, GOHRQoLh overall score | GOHRQoL [34] |
|
|
| Process outcome |
|
|
||
|
|
Safety, frequency of adverse events (%) | Safety Questionnaire (Adapted for Adults from [35]) | T0, T26, T52 | |
| Satisfaction, overall score | TSQMi (Modified for dental) [36] and Satisfaction with new treatment for cavities (Modified for adults from [37]) | T52 (for both satisfaction measures) | ||
| Moderators |
|
|
||
|
|
Sociodemographic, frequency (%) | NHANESj III [38] | T0 | |
| Medical condition, frequency (%) | Common chronic health condition for adults 65+ (Adapted from [39]) | T0 | ||
| Oral health behavior, overall score | Oral hygiene (Adapted from [40,41]) | T0 | ||
| Oral health symptoms, overall score | Self-reported measures of current oral disease/tissue damage (Adapted from [42]) | T0 | ||
aT0 = 0 week/Baseline visit/Baseline visual/tactile dental examination (Arm 1: SDF, Arm 2: ART + FV)
bT26=26-week follow-up visit/Visual/tactile dental examination (Arm 1, Arm 2).
cSDF: silver diamine fluoride.
dART: atraumatic restorative treatment.
eFV: fluoride varnish.
fT52=52-week final visit/Visual/tactile dental examination (final).
gICDAS: International Caries Detection and Assessment System.
hGOHRQoL: Geriatric Oral Health Quality of Life.
iTSQM: Treatment Satisfaction Questionnaire for Medication.
jNHANES: National Health and Nutrition Examination Survey.