Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Chronic Periodontitis
• Intervention / Treatment: Diagnostic test: Analysis of microbiological tests

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40120
    • Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
type 2 diabetics; Analysis of microbiological tests in chronic periodontitis patients with type 2 diabetes mellitus	Diagnostic test: Analysis of microbiological tests; Collection and comparison of microbiological data
non-diabetics; Analysis of microbiological tests in chronic periodontitis patients without type 2 diabetes mellitus	Diagnostic test: Analysis of microbiological tests; Collection and comparison of microbiological data

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Study Chair: Marco Montevecchi, DDS, University of Bologna

Publications and helpful links

General Publications

• Montevecchi M, Valeriani L, Gatto MR, D'Alessandro G, Piana G. Subgingival pathogens in chronic periodontitis patients affected by type 2 diabetes mellitus: a retrospective case-control study. J Periodontal Implant Sci. 2021 Dec;51(6):409-421. doi: 10.5051/jpis.2100180009.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2016
• Primary Completion (Actual): July 26, 2016
• Study Completion (Actual): November 16, 2016

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Comparative study; Chronic Periodontitis; Real-time PCR; Subgingival analysis
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: periopathogensdiabetes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available when the research will be published
• IPD Sharing Time Frame: Data will be available when the research will be published
• IPD Sharing Access Criteria: On request to the main investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No