Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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This study is a retrospective comparative evaluation of six main periodontal pathogens and total bacterial load in chronic periodontitis patients affected or not by type 2 diabetes mellitus by polymerase chain reaction analysis.

Detailed Description
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The aim of this study was to compare prevalence and bacterial load of six main periodontal pathogens among chronic periodontitis patients with and without type 2 diabetes mellitus. Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans genotypes were also investigated. The recruitment for the study sample was performed analysing the medical records of adult patients with chronic periodontitis visited between 2010 and 2016. Eligible patients were subdivided in two balanced groups on the basis of the presence or absence of type 2 diabetes mellitus at the time of the microbiological test. For each subject, the following data have been collected: age, gender, smoking habits, type of metabolic control of diabetes, duration of diabetes, number of missing teeth. For each subject, four periodontal sites were studied. Probing pocket depth, sites with bleeding on probing, sites with suppuration and microbiological data were evaluated. An individual matching on the basis of severity and extension of periodontitis was performed by pairing a diabetic patient with another non-diabetic one with the same degree of severity and extension of the periodontal disease. Microbiological data of subgingival biofilm were analysed and compared for the examined pathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, Fusobacterium nucleatum, Tannerella forsythia. Differences in genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans among diabetic and non-diabetic patients were also evaluated.

Official Title
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The Subgingival Microbiota in Chronic Periodontitis Patients Affected by Type 2 Diabetes Mellitus: a Retrospective Comparative Study

Conditions
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Chronic Periodontitis, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Diagnostic Test: Analysis of microbiological tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of chronic periodontitis diagnosis of type 2 diabetes mellitus (only in the test group) the presence of at least 12 teeth (except for the third molar) belonging to caucasian ethnic group age greater than 18 years. Exclusion Criteria: pregnant or lactating history of systemic antibiotics within 3 months prior to the microbiological testing or anti-inflammatory therapy in the month before the visit if they were suffering from any other systemic disease except diabetes mellitus (arthritis, ulcerative colitis, Crohn's disease, osteoporosis or osteopenia, HIV infection, hematologic diseases, neoplastic diseases, cardiovascular diseases or pathologies that could potentially interfere with the periodontitis and/or with diabetes) mental disorders if they had received periodontal treatment in the 6 months before the microbiological test.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 2 diabetics<br>Analysis of microbiological tests in chronic periodontitis patients with type 2 diabetes mellitus | Diagnostic Test: Analysis of microbiological tests<br>* Collection and comparison of microbiological data<br>|
| non-diabetics<br>Analysis of microbiological tests in chronic periodontitis patients without type 2 diabetes mellitus | Diagnostic Test: Analysis of microbiological tests<br>* Collection and comparison of microbiological data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial load of six main periodontal pathogens | Bacterial load mean of six main periodontal pathogens expressed as number after a polymerase chain reaction count | November 16th 2016 | 
| Prevalence of six main periodontal pathogens | Number of sites presenting a specific pathogen | November 16th 2016 | 
| Relative bacterial load of six main periodontal pathogens | A mean percentage that derives from the comparison of the bacterial load to the total bacterial load | November 16th 2016 | 
| Total bacterial load | A mean of all bacteria present in a periodontal site expressed as number after a polymerase chain reaction count | November 16th 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans | Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans were compared | November 16th 2016 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subgingival analysis, Real-time PCR, Comparative study, Chronic Periodontitis, Type 2 Diabetes Mellitus