Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03786133
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Marco Montevecchi, University of Bologna

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.

Condition or disease Intervention/treatment
Chronic Periodontitis Type 2 Diabetes Mellitus 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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Subgingival Microbiota in Chronic Periodontitis Patients Affected by Type 2 Diabetes Mellitus: a Retrospective Comparative Study
Actual Study Start Date : June 10, 2016
Actual Primary Completion Date : July 26, 2016
Actual Study Completion Date : November 16, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans [ Time Frame: November 16th 2016 ]
    Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans were compared



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786133


Locations
Layout table for location information
Italy
Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.
Bologna, Italy, 40120
Sponsors and Collaborators
University of Bologna
Investigators
Layout table for investigator information
Study Chair: Marco Montevecchi, DDS University of Bologna

Layout table for additonal information
Responsible Party: Marco Montevecchi, Aggregate Professor of Periodontology, University of Bologna
ClinicalTrials.gov Identifier: NCT03786133     History of Changes
Other Study ID Numbers: periopathogensdiabetes
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available when the research will be published
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available when the research will be published
Access Criteria: On request to the main investigator

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marco Montevecchi, University of Bologna:
Subgingival analysis
Real-time PCR
Comparative study
Chronic Periodontitis
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Chronic Periodontitis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases