The Effect of Lactobacillus salivarius SGL03 on Clinical and Microbiological Parameters in Periodontal Patients
, e | 27 nov 2020
INFORMAZIONI SU QUESTO ARTICOLO
Article Category: original-paper
Pubblicato online: 27 nov 2020
Pagine: 441 - 451
Ricevuto: 17 giu 2020
Accettato: 02 ott 2020
DOI: https://doi.org/10.33073/pjm-2020-047
Parole chiave
© 2020 Małgorzata Nędzi-Góra et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Composition of medical product and placebo (active ingredients are shown in bold).
| 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 | ||
Characteristics of Lactobacillus salivarius SGL03; (A) study group and placebo (B) group in terms of age.
| Group A | Group B | ||||
|---|---|---|---|---|---|
| Mean | SD | Mean | SD | ||
| 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 | ||
|---|---|---|---|---|
| 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 |
Mean values of colony-forming units (CFU) in Lactobacillus salivarius SGL03 (A) and placebo (B) group.
| 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 | ||||
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 | ||||
|---|---|---|---|---|---|
| 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 | | 0.279 |
| 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 |
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 – | 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% |