Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients

NCT03786133 | Completed DMC

• 1 other identifier: periopathogensdiabetes
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Periodontitis; Type 2 Diabetes Mellitus

Keywords

Subgingival analysis; Real-time PCR; Comparative study; Chronic Periodontitis; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans

  November 16th 2016

Study Arms (2)

type 2 diabetics

Analysis of microbiological tests in chronic periodontitis patients with type 2 diabetes mellitus

Diagnostic Test: Analysis of microbiological tests

non-diabetics

Analysis of microbiological tests in chronic periodontitis patients without type 2 diabetes mellitus

Diagnostic Test: Analysis of microbiological tests

Interventions

Analysis of microbiological tests DIAGNOSTIC_TEST

Collection and comparison of microbiological data

non-diabetics; type 2 diabetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

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

Bologna, 40120, Italy

Location

Related Publications (1)

• 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.

  PMID: 34965620 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marco Montevecchi, DDS

  University of Bologna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aggregate Professor of Periodontology

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 24, 2018
• Study Start: June 10, 2016
• Primary Completion: July 26, 2016
• Study Completion: November 16, 2016
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available when the research will be published
• Access Criteria: On request to the main investigator

Locations

IT (1)