Table 2 Treatment-emergent adverse events associated with DPSC injection in the safety set of the investigator-initiated trial
Single DPSC injection N = 33 n (%) | Double DPSC injection N = 30 n (%) | Saline injection N = 33 n (%) | ||||
|---|---|---|---|---|---|---|
Injection site swelling | 0 (0.0) | 1 (3.3) | 1 (3.0) | |||
Toothache | 1 (3.0) | 0 (0.0) | 0 (0.0) | |||
Relationship with DPSCs | possible | Certain | certain | |||
Clinical outcome | disappear | Disappear | disappear | |||
Phase I trial | 1 × 106 DPSCs /1 tooth N = 3 n (%) | 5 × 106 DPSCs/1 tooth N = 6 n (%) | 1 × 107 DPSCs/1 tooth N = 6 n (%) | 2 × 107 DPSCs/2 teeth N = 6 n (%) | 3–4 × 107 DPSCs/3–4 teeth N = 6 n (%) | Saline injection N = 9 n (%) |
At least 1 case of TEAE associated with the trial drug | 0 (0.0) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Gastrointestinal system diseases | 0 (0.0) | 2 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Diarrhea | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Gingival swelling | 0 (0.0) | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
