Effects of a Probiotic on Oral Microbiota and Glycemic Control in Type 2 Diabetics; A Randomized Clinical Trial
Condition: Diabetes Mellitus,Type 2; Periodontitis
MeSH terms: Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The present study evaluated clinically the effects of a probiotic on oral microbiota and
      glycemic control in T2 diabetic patients with periodontal disease. The study was designed as
      a prospective randomized, double-blind, placebo- controlled interventional study. At baseline
      and at the end of the 30 day- probiotic period, all clinical, microbiological, and
      biochemical measurements were tested. Colony counts of oral microbiota, blood fructosamine
      levels and CRP were the outcomes of the study.
    

Detailed description: 
      Objectives: To investigate the effects of an oral probiotic use, containing 4 billion colony
      forming unit (CFU/g) Streptococcus Salivarius M18 strain (Dentoblis™), on the quantities of
      oral microbiota in saliva and metabolic markers of T2 diabetics such as fructosamine,
      C-reactive protein (CRP).

      Materials and Methods: The trial was designed as a prospective randomized, double-blind,
      placebo- controlled interventional study. Participants were selected from type 2 diabetics
      with periodontitis and aged 30-65 years, who presented to the Diabetic Center in Istanbul.
      Totally 70 patients were randomly assigned to probiotic or placebo groups. At baseline and at
      the end of the 30 day-probiotic period, colony counts of oral microbiota and biochemical
      measurements of diabetes were assessed.
    

Intervention name(s): Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients
Intervention type(s): Dietary Supplement
Intervention description(s): The participants were randomized to the interventional groups, probiotic or placebo, by the diabetes nurse. During the intervention period of 30 nights, the participants were asked to let one Dentoblis™ or placebo lozenge slowly melt in their mouth for one minute before going to bed and after tooth brushing. Dentoblis™, as a test lozenge, contains 4x109 CFU/g S. salivarius M18 strain isolated from a healthy oral microbiota and has been utilized as oral probiotic inhibiting dental caries-causing pathogens.
The placebo is indistinguishable in form, size, color, and taste from the probiotic lozenge, but contains no bacteria. Placebo and probiotic lozenges were equivalent to 810 mg each and containing same amount of xylitol. Both were provided by the manufacturer, Bluestone Pharma GmbH, Baar, Switzerland, in equal white containers boxes, separated by production code. Neither the investigators nor the subjects were aware of the contents of the lozenges except for the research nurse.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The trial was a prospective randomized, double-blind, placebo-controlled intervention study.
All patients took an oral hygiene education and were invited to give paraffin-stimulated saliva, and blood samples in the Diabetic Center. All patients were examined clinically and the results of the intraoral examination were recorded. During the intervention period of 30 nights, the participants were asked to let one Dentoblis™ or placebo lozenge slowly melt in their mouth for at least one minute before going to bed and after tooth brushing. Dentoblis™, contains 4x 109 CFU/g S. salivarius M18 strain probiotic isolated from a healthy oral microbiota.
Neither the investigators nor the subjects were aware of the contents of the lozenges except for the research nurse, who was also responsible for keeping the codes and information confidential until after the statistical calculations. At baseline and at the end of the 30 day- intervention period, all measurements were retested.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Probiotics; Diabetes mellitus; Oral microbiota; Periodontitis; Streptococcus salivarius M18