Composition of medical product and placebo (active ingredients are shown in bold)_
| Medical product (Salistat SGL03) | Placebo | ||
|---|---|---|---|
| Vial content | Osmotic water | Osmotic water | |
| Gluco-oligosaccharides; prebiotic | X | ||
| Citric acid | Citric acid | ||
| Potassium sorbate | Potassium sorbate | ||
| Sodium lactate | Sodium lactate | ||
| Vanilla flavor | Vanilla flavor | ||
| Sucralose | Sucralose | ||
| Lemone.o. | X | ||
| Rosemary e.o. | X | ||
| Vial cap | Modified tapioca starch | Modified tapioca starch | |
| Lactoferrin | X | ||
| Live probiotic bacteria (L. salivarius SGL03) | X | ||
| Maltodextrin | Maltodextrin | ||
| Magnesium salts of fatty acids | Magnesium salts of fatty | acids | |
| Silicon dioxide | Silicon dioxide | ||
| cholecalciferol/colecalciferol | X | ||
Characteristics of Lactobacillus salivarius SGL03; (A) study group and placebo (B) group in terms of age_
| Group A | Group B | ||||
|---|---|---|---|---|---|
| Mean | SD | Mean | SD | p-value | |
| Age (years) | 55.35 | 12.42 | 53.28 | 14.38 | 0.585 |
Mean values of clinical variables (parameters) (PI, BOP, PD max, mean PD) in Lactobacillus salivarius SGL03 (A) and placebo (B) group and in the whole group (A+B)_
| Group | PI T0 | PI T1 | p-value | p-value A vs. B |
|---|---|---|---|---|
| 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 | 0.011* | |
| 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 | 0.027* | 0.291 |
| B | 2.46 | 2.44 | 0.740 | |
| A + B | 2.48 | 2.43 | 0.107 |
Mean values of colony-forming units (CFU) in Lactobacillus salivarius SGL03 (A) and placebo (B) group_
| Group A | Ggroup B | p-value (A vs. 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 |
| p-value (T0 vs T1) | 0.221 | 0.829 | |||
Number and percentage of patients divided according to sex; (A) Lactobacillus salivarius SGL03 study group, (B) placebo group_
| 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%) |
Initial mean values of clinical variables (parameters) (PI, BOP, PD max, mean PD) in Lactobacillus salivarius SGL03 (A) and placebo (B) group_
| Group A | Group B | p-value | |||
|---|---|---|---|---|---|
| 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 |
Spearman’s rank correlation indices between microbiological and clinical parameters in Lactobacillus salivarius SGL03 (A) and placebo (B) group_
| CFU T1 | CFU T0 | ΔCFU (T1 – T0) | |
|---|---|---|---|
| Group A | |||
| PI T0 | 0.321 | 0.565* | 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 | -0.431* | -0.088 | 0.106 |
| PD max T1 | -0.423* | 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 | 0.503* | 0.136 | -0.138 |
| PI T1 | 0.395 | 0.619* | 0.323 |
| ΔPI (T1 – T0) | 0.211 | 0.720* | 0.476* |
| BOP T0 | 0.279 | 0.441* | 0.264 |
| BOP T1 | 0.271 | 0.424* | 0.357 |
| ΔBOP (T1 – T0) | -0.028 | -0.002 | 0.119 |
| PD max T0 | -0.069 | 0.309 | 0.428* |
| PD max T1 | -0,077 | 0.379 | 0.495* |
| ΔPD max (T1 – T0) | -0.021 | 0.166 | 0.182 |
| Mean PD T0 | 0.074 | 0.578* | 0.456* |
| Mean PD T1 | 0.135 | 0.496* | 0.381 |
| Δmean PD (T1 – T0) | -0.071 | -0.183 | 0.008 |
The results of a questionnaire regarding subjective assessment of taste, convenience of use, effect on the state of gums and mucosa as well as potential adverse effects of Lactobacillus salivarius SGL03 (A) or placebo (B)_
| Group A – Lactobacillussalivarius SGL03 | 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% |