Clinical trial NCT03786133: Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients
Official title: The Subgingival Microbiota in Chronic Periodontitis Patients Affected by Type 2 Diabetes Mellitus: a Retrospective Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Periodontitis
Type 2 Diabetes Mellitus
Keywords: Subgingival analysis
Real-time PCR
Comparative study
Chronic Periodontitis
Type 2 Diabetes Mellitus
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Bacterial load of six main periodontal pathogens
timeFrame: November 16th 2016
measure: Prevalence of six main periodontal pathogens
timeFrame: November 16th 2016
measure: Relative bacterial load of six main periodontal pathogens
timeFrame: November 16th 2016
measure: Total bacterial load
timeFrame: November 16th 2016
Secondary outcomes:
measure: Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans
timeFrame: November 16th 2016
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.
Study officials:
affiliation: University of Bologna
name: Marco Montevecchi, DDS
role: STUDY_CHAIR
References:
citation: 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.