Table 3.
Study schedule of procedures (reference group—arm C).
| Procedure | Screening | Enrollment (V0); day 0 | Baseline (V1); day 14±3 | Week 12 (V2); day 90±5 | Week 24 (V3); day 180±7 | Week 52 (V4); day 360±7 | Week 76 (V5); day 540±7 |
| Eligibility criteria check | ✓ | ✓ |
|
|
|
|
|
| Medical and oral health Hxa | ✓ |
|
|
|
|
|
|
| Smoking Hx | ✓ |
|
|
|
|
|
|
| Cigarette consumption | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Exhaled COb | ✓ |
|
|
|
|
|
|
| Informed consent |
|
✓ |
|
|
|
|
|
| Oral hygiene check | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Periodontal examination | ✓ |
|
|
|
|
|
|
| Scaling and polishing |
|
✓ |
|
|
|
|
✓ |
| Assignment to arm C |
|
✓ |
|
|
|
|
|
| Tracker app installation |
|
✓ |
|
|
|
|
|
| BPc, HRd, weight, height, and BMI |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| MGIe assessment |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Plaque score imaging |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Dental shade quantitation |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Tooth stain assessment |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| QoLf questionnaires (OHQoLg and EQ VASh) |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Safety reporting |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
aHx: history.
bCO: carbon monoxide.
cBP: blood pressure.
dHR: heart rate.
eMGI: Modified Gingival Index.
fQoL: Quality of Life.
gOHQoL: Oral Health Quality of Life.
hEQ VAS: EuroQoL Visual Analog Scale.