Table 2.
Measurements and timepoints.
| Timepoint | Study period | ||||
|
|
–T1a | T0b | T1c | T2d | |
| Enrollment |
|
|
|
|
|
|
|
Eligibility screening | ✓e |
|
|
|
|
|
Informed consent | ✓ |
|
|
|
|
|
Allocation | ✓ |
|
|
|
| Interventions |
|
|
|
|
|
|
|
Toddler Oral Health Intervention performed at ages 6-8, 11, 14-15, 18, 24, 30, and 36 months |
|
✓ | ✓ | ✓ |
|
|
Care as usual |
|
✓ | ✓ | ✓ |
| Primary outcome |
|
|
|
|
|
|
|
Clinical assessment of cumulative caries incidence with Merged International Caries Detection and Assessment System [40] |
|
|
|
✓ |
| Secondary outcomes |
|
|
|
|
|
|
|
Clinical assessment of average number of decayed, missing, and filled surfaces and teeth with Merged International Caries Detection and Assessment System |
|
|
✓ | ✓ |
|
|
Clinical assessment of person time at risk for first cavity with Merged International Caries Detection and Assessment System and incidence density |
|
|
✓ | ✓ |
|
|
Clinical assessment of consequences of untreated dental caries with the PUFA (visible pulpal involvement, ulceration caused by dislocated tooth fragments, fistula, and abscess) index |
|
|
✓ | ✓ |
|
|
Clinical assessment of presence of dental plaque with Simplified Oral Hygiene Index, 6-surface method [41] |
|
|
✓ | ✓ |
|
|
Online questionnaire assessment of oral health behavior with self-developed items |
|
✓ | ✓ | ✓ |
|
|
Online questionnaire assessment of psychosocial constructs of the Health Action Process Approach items (action self-efficacy, risk perception, outcome expectancies, intention, action planning, coping planning, and action control), adapted from Gholami and Schwarzer (2014) [42] |
|
✓ | ✓ | ✓ |
|
|
Online questionnaire assessment of oral health–related quality of life with the Early Childhood Oral Health Related Quality of Life [43] scale |
|
|
✓ | ✓ |
|
|
Online questionnaire assessment of child cooperativeness at oral examinations with the Frankl behavior scale [44] |
|
|
✓ | ✓ |
| Compliance, fidelity, and cost outcome measures |
|
|
|
|
|
|
|
Total care delivered by oral health coach, assessed by frequency and time in minutes as reported by the oral health coach |
|
|
✓ | ✓ |
|
|
Reasons for and number of visits to a dental clinic (other than Toddler Oral Health Intervention), assessed by parent interviews |
|
|
|
✓ |
|
|
Oral health coach mastery of motivational interviewing competencies, assessed by applying Motivational Interviewing Treatment Integrity codes to audio recordings [39] |
|
✓ | ✓ | ✓ |
a–T1: screening and allocation.
bT0: baseline.
cT1: follow-up at age 24 months.
dT2: follow-up at age 48 months.
e✓: measurement or action performed at this time point.