Medical product (Salistat SGL03) | Placebo | ||
---|---|---|---|
Vial content | Osmotic water | Osmotic water | |
X | |||
Citric acid | Citric acid | ||
Potassium sorbate | Potassium sorbate | ||
Sodium lactate | Sodium lactate | ||
Vanilla flavor | Vanilla flavor | ||
Sucralose | Sucralose | ||
X | |||
X | |||
Vial cap | Modified tapioca starch | Modified tapioca starch | |
X | |||
X | |||
Maltodextrin | Maltodextrin | ||
Magnesium salts of fatty acids | Magnesium salts of fatty | acids | |
Silicon dioxide | Silicon dioxide | ||
cholecalciferol/colecalciferol | X |
Group A | Group B | ||||
---|---|---|---|---|---|
Mean | SD | Mean | SD | ||
Age (years) | 55.35 | 12.42 | 53.28 | 14.38 | 0.585 |
Group | PI T0 | PI T1 | ||
---|---|---|---|---|
A | 55.38 | 51.61 | 0.186 | 0.978 |
B | 56.81 | 52.92 | 0.309 | |
A + B | 56.08 | 52.25 | 0.101 | |
Group | BOP T0 | BOP T1 | ||
A | 20.39 | 18.11 | 0.071 | 0.813 |
B | 20.30 | 17.57 | 0.077 | |
A + B | 20.34 | 17.84 | ||
Group | PD max T0 | PD max T1 | ||
A | 4.88 | 4.58 | 0.161 | 0.484 |
B | 4.96 | 4.84 | 0.450 | |
A + B | 4.92 | 4.71 | 0.109 | |
Group | Mean PD T0 | Mean PD T1 | ||
A | 2.50 | 2.42 | 0.291 | |
B | 2.46 | 2.44 | 0.740 | |
A + B | 2.48 | 2.43 | 0.107 |
Group A | Ggroup B | ||||
---|---|---|---|---|---|
mean | SD | mean | SD | ||
CFU T0 | 5.32 × 107 | 7.01 × 107 | 1.18 × 108 | 1.65 × 108 | 0.074 |
CFU T1 | 8.77 × 107 | 1.21 × 108 | 1.09 × 108 | 1.15 × 108 | 0.528 |
CFU (Tl – TO) | 3.45 × 107 | 1.40 × 108 | -8.88 × 106 | 2.03 × 108 | 0.377 |
0.221 | 0.829 |
Sex | Group A | Group B |
---|---|---|
F (females) | 19 (73.1%) | 16 (64.0%) |
M (males) | 7 (26.9%) | 9 (36.0%) |
Total | 26 (100%) | 25 (100%) |
Group A | Group B | ||||
---|---|---|---|---|---|
Mean | SD | Mean | SD | ||
PI | 55.38 | 20.50 | 56.81 | 16.14 | 0.783 |
BOP | 20.39 | 11.44 | 20.30 | 11.74 | 0.978 |
PD max | 4.88 | 1.34 | 4.96 | 1.06 | 0.825 |
Mean PD | 2.50 | 0.48 | 2.46 | 0.46 | 0.757 |
CFU T1 | CFU T0 | ΔCFU (T1 – T0) | |
---|---|---|---|
Group A | |||
PI T0 | 0.321 | | 0.279 |
PI T1 | 0.299 | 0.312 | 0.049 |
ΔPI (T1 – T0) | 0.019 | -0.166 | -0.172 |
BOP T0 | 0.008 | 0.237 | 0.025 |
BOP T1 | -0.134 | 0.360 | 0.253 |
ΔBOP (T1 – T0) | -0.035 | 0.189 | 0.243 |
PD max T0 | -0.088 | 0.106 | |
PD max T1 | 0.097 | 0.227 | |
ΔPD max (T1 – T0) | 0.053 | 0.194 | 0.098 |
Mean PD T0 | -0.089 | 0.033 | 0.057 |
Mean PD T1 | 0.017 | 0.046 | 0.005 |
Δmean PD (T1 – T0) | 0.082 | -0.150 | -0.164 |
Group B | |||
PI T0 | | 0.136 | -0.138 |
PI T1 | 0.395 | | 0.323 |
ΔPI (T1 – T0) | 0.211 | | |
BOP T0 | 0.279 | | 0.264 |
BOP T1 | 0.271 | | 0.357 |
ΔBOP (T1 – T0) | -0.028 | -0.002 | 0.119 |
PD max T0 | -0.069 | 0.309 | |
PD max T1 | -0,077 | 0.379 | |
ΔPD max (T1 – T0) | -0.021 | 0.166 | 0.182 |
Mean PD T0 | 0.074 | | |
Mean PD T1 | 0.135 | | 0.381 |
Δmean PD (T1 – T0) | -0.071 | -0.183 | 0.008 |
Group A – | Group B – Placebo | |||
---|---|---|---|---|
Number of patients | % | Number of patients | % | |
Taste | ||||
1 – good | 16 | 61.5% | 20 | 80.0% |
2 – neutral | 7 | 26.9% | 4 | 16.0% |
3 – unpalatable | 3 | 11.5% | 1 | 4.0% |
Convenience of use | ||||
1 – convenient | 16 | 61.5% | 19 | 76.0% |
2 – neutral | 7 | 26.9% | 4 | 16.0% |
3 – uncomfortable | 3 | 11.5% | 2 | 8.0% |
Effect on the state of gums | ||||
1 – improved | 12 | 46.2% | 15 | 60.0% |
2 – unchanged | 14 | 53.8% | 10 | 40.0% |
Effect on the oral mucosa condition | ||||
1 – improved | 15 | 57.7% | 13 | 52.0% |
2 – unchanged | 11 | 42.3% | 12 | 48.0% |
Adverse reactions | ||||
0 – no | 23 | 88.5% | 24 | 96.0% |
1 – yes | 3 | 11.5% | 1 | 4.0% |