Impact of Oral Probiotics on Oral Homeostasis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Aim:

      To evaluate the effect of three months use of tablets containing probiotics on the
      composition of the supragingival plaque microbiota and salivary levels of
      inflammation-related proteins in oral healthy individuals.

      Hypothesis:

      Three months use of tablets containing probiotics will induce quantifiable changes to the
      composition of the supragingival plaque microbiota and salivary levels of
      inflammation-related proteins in oral healthy individuals.

      Perspectives:

      Data from the present study will be able to reveal the impact of regular use of probiotics on
      oral homeostasis in oral healthy individuals. Specifically, simultaneous registration of
      clinical, microbial and inflammatory characteristics will provide comprehensive information
      on the potential beneficial effect of regular use of oral probiotics on maintenance of oral
      homeostasis. Thus, data from the present study will provide a scientific platform, which
      dentist and dental hygienist can utilize when deciding if oral healthy individuals may
      benefit from using oral probiotics as a supplement to regular oral hygiene.
    

Detailed description: 
      Oral health is built upon a symbiotic relationship between the resident oral microbiota and
      the immune system of the host. Therefore, structural or functional changes to either the
      microbiota or the immune system may result in dysbiosis, which in turn can lead to oral
      diseases such as gingivitis, periodontitis and dental caries.

      The composition of the resident oral microbiota in oral health is shaped by ecological
      properties found at various sites of the oral cavity, which is why major site-specific
      variations are observed. Interestingly, the composition of the oral microbiota is
      individualized and relatively time stable as long as oral homeostasis is maintained. However,
      structure and function of the oral microbiota can be altered by internal and external
      perturbations. For example, it has previously demonstrated that oral hygiene discontinuation
      induces structural changes to the supragingival plaque microbiota, whereas non-surgical
      periodontal treatment has deep impact on the composition of the subgingival plaque
      microbiota. Interestingly, a recent study demonstrated that the composition of the resident
      oral microbiota may also be influenced by external perturbations. Specifically, daily use of
      ZendiumTM toothpaste for 12 weeks was reported to induce significant changes to the
      supragingival plaque microbiota in oral healthy individuals with an increase in
      health-associated bacterial species.

      Probiotics is the term used when a harmless effector strain is implanted in the host's
      microbiota to maintain or restore a natural microbiome by interference and/or inhibition of
      other microorganisms, and especially pathogens. In a recent study, it was demonstrated an
      effect of using tablets containing a mix of Lactobacillus rhamnosus PB01, DSM 14869 and
      Lactobacillus curvatus EB10, DSM 32307 on gingival inflammation. Specifically, daily use of
      this probiotic candidate for four weeks resulted in significant reduction in clinical
      parameters such as bleeding on probing (BOP) and amount of gingival crevicular fluid (GCF).

      However, at present it is not known if daily use of a probiotic tablet containing a mix of L.
      rhamnosus PB01, DSM 14869 and L. curvatus EB10, DSM 32307 is able to induce shifts to the
      composition of the oral microbiota, or cause a decrease in salivary levels of
      inflammation-related proteins such as neutrophil gelatinase-associated lipocalin (NGAL) and
      transferrin, which is the purpose of the present study.
    

Intervention name(s): Probiotic tablet; Placebo tablet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic tablet twice a day for 12 weeks; Placebo tablet twice a day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double blind clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention