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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 10  |  Issue : 1  |  Page : 32-35

To assess the efficacy of Bacillus clausii UBB-07 2 Billion spores on gingivitis: A randomized control trial


1 Department of Periodontics, Sri Hasanamba Dental College and Hospital, Hassan, Karnataka, India
2 Department of Periodontics, JSS Dental College, Mysore, Karnataka, India

Date of Submission25-Mar-2019
Date of Acceptance11-Nov-2019
Date of Web Publication16-Jul-2020

Correspondence Address:
Dr. M R Vivekananda
Associate Dean (HR), Professor, Department of Periodontics, Sri Hasanamba Dental College and Hospital, Hassan, Karnataka 573 202
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijohs.ijohs_12_19

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  Abstract 


Background and Objectives: The aim of this study was to evaluate the effects of probiotic Bacillus clausii UBBC-07 2 Billion spores alone and in combination with scaling in a randomized, placebo-controlled clinical trial of volunteers with chronic generalized gingivitis.
Materials and Methods: Thirty otherwise systemically healthy, chronic generalized gingivitis subjects (both males and females, aged between 18 and 40 years) were included. Selected subjects were randomly divided into two groups. The study period was 7 days. “Split-mouth” design was used for scaling, which was performed on day 0; two quadrants (either right or left) were treated with scaling whereas the remaining two quadrants were left untreated. Participants in the test group received probiotics, B. clausii UBB-07-2 Billion spores as mouth rinse twice daily for 7 days and in the control group received placebo rinse twice daily for 7 days. Further treatment for the subjects was carried out after 7 days. Statistical analysis was done for comparisons of clinical parameters (plaque index [PI], gingival index [GI], and sulcus bleeding index [SBI]). A P < 0.05 was considered statistically significant. Assessments were made on day 0 before scaling treatment, on day 0 before administration of the mouth rinse, and on day 7.
Results: At day 7, the PI, GI, and SBI were significantly reduced by all treatment modalities. When ranked, the amount of PI, GI, and SBI reduction by the different treatments were scaling with probiotics, probiotics, scaling with placebo, placebo all differences were statistically significant.
Conclusion: The present randomized double-blind controlled trial confirms the plaque inhibition effects of B. clausii UBB-07-2 Billion spores probiotics. B. clausii UBB-07-2 Billion spores probiotic can be recommended alone and in combination with scaling and also during the maintenance phase of periodontal treatment.

Keywords: Bacillus clausii, chronic generalized gingivitis, placebo, probiotics, scaling, spore


How to cite this article:
Vivekananda M R, Vasthavi C, Harsha M B, Shivaparasad D, Ravindra S. To assess the efficacy of Bacillus clausii UBB-07 2 Billion spores on gingivitis: A randomized control trial. Int J Oral Health Sci 2020;10:32-5

How to cite this URL:
Vivekananda M R, Vasthavi C, Harsha M B, Shivaparasad D, Ravindra S. To assess the efficacy of Bacillus clausii UBB-07 2 Billion spores on gingivitis: A randomized control trial. Int J Oral Health Sci [serial online] 2020 [cited 2020 Oct 25];10:32-5. Available from: https://www.ijohsjournal.org/text.asp?2020/10/1/32/289869




  Introduction Top


Probiotics can be defined as living microbes or as food ingredients containtabeleing living microbes that beneficially influence the health of the host when used in adequate numbers.[1] As validated by the International Scientific Association for probiotics and prebiotics, “live microorganisms, which when administered in adequate amounts, confer beneficial effect on the health of the host.”

The idea of probiotics came to existence in the first decade of 1900s when the Ukranian bacteriologist and Nobel Laureate Metchnikof (1908) were studying the flora of human intestine and developed a theory that senility in humans is caused by poisoning of body by the products of some of these bacteria. To prevent the multiplication of these organisms, they proposed a diet containing milk fermented by lactobacilli, which produces large amounts of lactic acid that could increase the life span of humans. The notion of probiotics was thus born and a new discipline of bacteriology was opened.[1]

Lilley and Stillwell (1965) introduced the term probiotics. Hull, in 1984, discovered the first probiotic species, Lactobacillus acidophilus. Later, in 1991, Holcombh identified Bifidobacterium bifidum. The WHO in 1994 described the probiotics as the next most important in immune defense system following antibiotic resistance. This prevalence leads the way for a new abstraction of probiotics in medicine and dentistry.[2]

Bacillus species which are spore-forming bacteria have been used as probiotics for the last five decades. The edge of spore-forming probiotics over nonspore formers such as Lactobacillus spp. is that they can be stored at room temperature without any loss of viability and are heat stable. Spore-forming bacteria are also resistant to acidic conditions. The immune response can be modulated by a probiotic Bacillus clausii.[3],[4]

B. clausii is currently being studied in respiratory infections, oral candidiasis, and aphthous ulcer. The effect of B. clausii on the periodontium is unknown. Therefore, the aim of the study was to assess the efficacy of B. clausii UBB-07-2 Billion spores on gingivitis.


  Materials and Methods Top


This was a randomized, placebo-controlled, split-mouth designed clinical study to evaluate the effect of probiotic B. clausii UBB-07-2 Billion spores with and without scaling on the clinical parameters.

Patients of both sexes within the age limit of 18–40 years were eligible for inclusion. Patients diagnosed as suffering from chronic generalized gingivitis with 30% sites with bleeding on probing and right-handed subjects were included. Apart from having chronic generalized gingivitis, the patients were in good general health. No patient had ongoing antibiotic treatment or any systemic disease. Patients who were pregnant, lactating, smokers, alcoholic, or who had undergone any periodontal therapy within 6 months before the start of the study were excluded from the study. Informed consent was obtained in writing from all the subjects included in the study.

All subjects were assigned to one of the two groups (probiotics group or placebo group) using randomization (chit method) as shown in consort chart [Figure 1]. Probiotics were procured from Karnataka Antibiotics and Pharmaceuticals Ltd., Bangalore. Clinical parameters recorded were plaque index (PI), gingival index (GI), and sulcus bleeding index (SBI) and were recorded at baseline (day 0) and on day 7. The clinical parameters recorded were PI, GI, and SBI. All parameters were assessed by a single clinical investigator. Split-mouth scaling in all patients was achieved by treating two quadrants with scaling on day 0 while two quadrants were left untreated. Scaling of other two quadrants was completed after completion of the study. Participants in the test group received probiotics, B. clausii UBB-07-2 Billion spores as mouth rinse twice daily for 7 days and in the control group received placebo rinse twice daily for 7 days. The patients were instructed to perform regular oral hygiene habits, i.e., twice-daily brushing for a minimum of 2 min, followed by mouth rinse for 7 days. All clinical and data collected were subjected to statistical analysis.
Figure 1: Consort chart

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  Results Top


All subjects completed the 7-day study period. There were no significant differences in the clinical parameters between the Probiotic and placebo groups on day 0. A P < 0.05 was considered statistically significant. The power size was 0.8. The effect size calculated was 1.1.

The mean difference in PI score of probiotic scaling group was 0.926 ± 0.186, of probiotic group was 0.386 ± 0.124, of placebo scaling group was 0.593 ± 0.127, and of placebo without scaling group was 0.026 ± 0.045. There were statistically significant differences in PI score among four groups (i.e., P < 0.001) [Graph 1] and [Table 1] and [Table 2].
Table 1: One way ANOVA

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Table 2: Scheffe post hoc test

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The mean difference in SBI score of probiotic scaling group was 1.933 ± 0.258, of probiotic group was 0.466 ± 0.516, of placebo scaling group was 1.200 ± 0.414, and of placebo without scaling group was −0.066 ± 0.258. There were statistically significant differences in SBI score among four groups (i.e., P < 0.001). [Graph 2] and [Table 1] and [Table 2].

The mean difference in GI score of probiotic scaling group was 0.966 ± 0.134, of probiotic group was 0.326 ± 0.045, of placebo scaling group was 0.542 ± 0.155, and of placebo without scaling group was 0.013 ± 0.083. There were statistically significant differences in GI score among four groups (i.e., P < 0.001) [Graph 3] and [Table 1] and [Table 2].



Scheffe post hoc test was used for pairwise comparisons; there was a statistically significant difference in mean PI, SBI, and GI score between each pair.



Within both the probiotic and the placebo groups, with PI, GI, and SBI, the reduction was highly significant with treatment. The maximum reduction of PI, GI, and SBI was obtained for the combination of scaling and probiotics, which was statistically significant when compared to all other treatment modalities. In the untreated quadrants, probiotics was significantly better than the placebo.


  Discussion Top


An initial attempt has been made in this randomized, double-blind clinical trial to evaluate and compare the benefits of the probiotic alone and scaling with probiotics in the treatment of chronic generalized gingivitis.

In both the probiotics and the placebo groups, PI, GI, and SBI were significantly reduced within each treatment group over 7 days except for placebo group. In the probiotic group, the combination of scaling and probiotics demonstrated a significant reduction of PI, GI, and SBI when compared to scaling and probiotic effects individually; thus, the plaque reduction brought about by scaling was enhanced by the use of probiotics.

In oral cavity, probiotics can create a biofilm, acting as a protective lining for oral tissues against oral diseases.[5]

Lactobacillus and Bifidobacterium spp. have earned many health claims, including the potential to modulate host physiology via direct and indirect means.[6] In a recent study, 20 healthy European subjects were orally administered with Enterogermina-containing spores of four strains of B. clausii, which could survive transit through the human gastrointestinal tract during which germination; out-growth and multiplication could happen.[7] The available data from these studies have presented the beneficial effects of different strains of Bacillus spp. for human health. For example, several researchers have recognized the preventive role of Bacillus probiotic in gut physiology impairment condition.[8]

The probiotic B. clausii strain protected vero and Caco-2 cell from the cytotoxic effect of Clostridium difficile and B. cereus toxins.[9]

Enterogermina contains spores of four strains of B. clausii, which are resistant toward tetracycline and chloramphenicol. Suspension of these spores is used as medical supplement along with antibiotics against infantile diarrhea.[10]


  Conclusion Top


The present randomized, double-blind controlled trial confirms the plaque inhibition effects of B. clausii UBB-07 2 Billion spores probiotic. B. clausii UBB-07 2 Billion spores can be recommended alone and in combination with scaling and also during the maintenance phase of periodontal treatment. Further studies are required in this direction.

From the results obtained, the following conclusions could be drawn from this study:

  • Probiotic B. clausii UBB-07-2 Billion spores is a promising modality of treatment, offering some benefits over scaling.


Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Meurman JH, Stamatova I. Probiotics: Contributions to oral health. Oral Dis 2007;13:443-51.  Back to cited text no. 1
    
2.
Ciprandi G, Vizzaccaro A, Cirillo I. Bacillus clausii effects in children with allergic rhinitis. Eur Ann Allergy Clin Immunol 2005;60:702-3.  Back to cited text no. 2
    
3.
Ciprandi G, Vizzaccaro A, Cirillo I, Tosca MA. Bacillus clausii exerts immuno-modulatory activity in allergic subjects: A pilot study. Eur Ann Allergy Clin Immunol 2005;37:129-34.  Back to cited text no. 3
    
4.
Caglar E, Kargul B, Tanboga I. Bacteriotherapy and probiotics' role on oral health. Oral Dis 2005;11:131-7.  Back to cited text no. 4
    
5.
Di Caro S, Tao H, Grillo A, Franceschi F, Elia C, Zocco MA, et al. Bacillus clausii effect on gene expression pattern in small bowel mucosa using DNA microarray analysis. Eur J Gastroenterol Hepatol 2005;17:951-60.  Back to cited text no. 5
    
6.
Ghelardi E, Celandroni F, Salvetti S, Gueye SA, Lupetti A, Senesi S. Survival and persistence of Bacillus clausii in the human gastrointestinal tract following oral administration as spore-based probiotic formulation. J Appl Microbiol 2015;119:552-9.  Back to cited text no. 6
    
7.
Lopetuso LR, Scaldaferri F, Franceschi F, Gasbarrini A. Bacillus clausii and gut homeostasis: State of the art and future perspectives. Expert Rev Gastroenterol Hepatol 2016;10:943-8.  Back to cited text no. 7
    
8.
Ripert G, Racedo SM, Elie AM, Jacquot C, Bressollier P, Urdaci MC. Secreted compounds of the probiotic Bacillus clausii strain O/C inhibit the cytotoxic effects induced by Clostridium difficile and Bacillus cereus toxins. Antimicrob Agents Chemother 2016;60:3445-54.  Back to cited text no. 8
    
9.
Senesi S, Celandroni F, Tavanti A, Ghelardi E. Molecular characterization and identification of Bacillus clausii Strains marketed for use in oral bacteriotherapy. Appl Environ Microbiol 2001;67:834-9.  Back to cited text no. 9
    
10.
Abbrescia A, Palese LL, Papa S, Gaballo A, Alifano P, Anna MS. Antibiotic sensitivity of Bacillus clausii strain in commercial preparation. Curr Med Chem. 2014;1:102-10.  Back to cited text no. 10
    


    Figures

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    Tables

  [Table 1], [Table 2]



 

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