Skip to main content
OpenTrials
Completed

NCT Number: NCT03786133

Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bologna, 40120, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Analysis of microbiological tests

Diagnostic Test

Collection and comparison of microbiological data

Primary outcomes

  1. Bacterial load of six main periodontal pathogens

    Time frame: November 16th 2016

    Bacterial load mean of six main periodontal pathogens expressed as number after a polymerase chain reaction count

  2. Prevalence of six main periodontal pathogens

    Time frame: November 16th 2016

    Number of sites presenting a specific pathogen

  3. Relative bacterial load of six main periodontal pathogens

    Time frame: November 16th 2016

    A mean percentage that derives from the comparison of the bacterial load to the total bacterial load

  4. Total bacterial load

    Time frame: November 16th 2016

    A mean of all bacteria present in a periodontal site expressed as number after a polymerase chain reaction count

Secondary outcomes

  1. Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans

    Time frame: November 16th 2016

    Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans were compared

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2018
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.