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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dentoblis™ group | Active Comparator | 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. |
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| Placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Oral Microbiota colony counts at baseline and after intervention | Colony counts of periodontal pathogens, S.mutans and candidas were determined 30 day after the use of the Probiotic in CFU/g | 30 days |
| Change in blood fructosamine levels in Type 2 diabetic patients an Oral probiotic use | Clinical marker of Type 2 diabetics such as CRP and fructosamine were determined 30 day after the use of the Probiotic | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yeliz Mercan, PhD | Kırklareli University, Turkey | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23449874 | Background | Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28. | |
| 21311610 |
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As of January 2022
No criteria
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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.
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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. Statistical analysis were performed by a blind assessor.
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| Soderling E, Hirvonen A, Karjalainen S, Fontana M, Catt D, Seppa L. The effect of xylitol on the composition of the oral flora: a pilot study. Eur J Dent. 2011 Jan;5(1):24-31. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D010518 | Periodontitis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D038321 | Glycemic Index |
| ID | Term |
|---|---|
| D009753 | Nutritive Value |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D063427 | Food Quality |
| D005524 | Food Technology |
| D019649 | Food Industry |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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