Effects of a Probiotic on Oral Microbiota and Glycemic Control in Type 2 Diabetics; A Randomized Clinical Trial
- Conditions
- PeriodontitisDiabetes Mellitus,Type 2
- Interventions
- Dietary Supplement: Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients
- Registration Number
- NCT04913909
- Lead Sponsor
- Istanbul University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- being diagnosed with T2 diabetes with <10% HbA1C for at least 6 months,
- 30-65 years old patients,
- high caries activity patients with Periodontal Disease Index (PDI) scores of 2, 3, 4 and 5,
- provision of written informed consent -
- patients regularly using probiotics,
- patients on corticosteroid, non-steroid anti-inflammatory, antibiotic or antibacterial mouthwash therapy,
- patients with multi-organ deficiency such as liver or kidney failure,
- patients with Immunodeficiency syndrome or on immunosuppressive therapy,
- patients with heart valve prosthesis or central venous catheter,
- patients undergoing chronic or acute disease therapy such as cancer, arthritis, influenza, flu,
- legal incapability or mental incapacity to give consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dentoblis™ group Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients In Probiotic group; Dentoblis™, as a test lozenge, contains 4 billion CFU/g S. salivarius M18 strain probiotic isolated from a healthy oral microbiota, has been utilized one lozenge a day for 30 days. Placebo group Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients The placebo was indistinguishable in form, size, color, smell and taste from the probiotic lozenge, but contained no bacteria and utilized one lozenge a day for 30 days . 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.
- Primary Outcome Measures
Name Time Method Change in the Oral Microbiota colony counts at baseline and after intervention 30 days Colony counts of periodontal pathogens, S.mutans and candidas were determined 30 day after the use of the Probiotic in CFU/g
Change in blood fructosamine levels in Type 2 diabetic patients an Oral probiotic use 30 days Clinical marker of Type 2 diabetics such as CRP and fructosamine were determined 30 day after the use of the Probiotic
- Secondary Outcome Measures
Name Time Method