Table 1.
Study schedule of procedures (control group—arm A).
| 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 | ✓ |
|
|
|
|
|
|
| Intention to quit smoking | ✓ |
|
|
|
|
|
|
| Smoking cessation advice | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Cigarette consumption | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Exhaled COb | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Interest to switch to C-F NAc | ✓ |
|
|
|
|
|
|
| Informed consent |
|
✓ |
|
|
|
|
|
| FTNDd |
|
✓ |
|
|
|
|
|
| Oral hygiene check | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Periodontal examination | ✓ |
|
|
|
|
|
|
| Scaling and polishing |
|
✓ |
|
|
|
|
✓ |
| Randomization |
|
✓ |
|
|
|
|
|
| Tracker app installation |
|
✓ |
|
|
|
|
|
| BPe, HRf, weight, height, and BMI |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| MGIg assessment |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Plaque score imaging |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Dental shade quantitation |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Tooth stain assessment |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| QoLh questionnaires (OHQoLi and EQ VASj) |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Safety reporting |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
aHx: history.
bCO: carbon monoxide.
cC-F NA: combustion-free nicotine alternatives.
dFTND: Fagerström Test for Nicotine Dependence.
eBP: blood pressure.
fHR: heart rate.
gMGI: Modified Gingival Index.
hQoL: Quality of Life.
iOHQoL: Oral Health Quality of Life.
jEQ VAS: EuroQoL Visual Analog Scale.