The Effect of Lactobacillus salivarius SGL03 on Clinical and Microbiological Parameters in Periodontal Patients

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%