Chronic PeriodontitisNCT03786133
Chronic Periodontitis Microbiota in Type 2 Diabetes Mellitus Patients
An observational study of Chronic Periodontitis and Type 2 Diabetes Mellitus, run by University of Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Periodontitis, Type 2 Diabetes Mellitus
- What is being tested?
- Analysis of microbiological tests
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2016to 16 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.
Bologna, 40120
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Periodontitis, Type 2 Diabetes Mellitus
- Being tested
- Analysis of microbiological tests
- Keywords
- Subgingival analysis, Real-time PCR, Comparative study, Chronic Periodontitis, Type 2 Diabetes Mellitus
- Medical subject headings
- Chronic Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of microbiological testsDiagnostic test
Collection and comparison of microbiological data
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetics | Analysis of microbiological tests in chronic periodontitis patients with type 2 diabetes mellitus Receives: Diagnostic Test: Analysis of microbiological tests | |
| non-diabetics | Analysis of microbiological tests in chronic periodontitis patients without type 2 diabetes mellitus Receives: Diagnostic Test: Analysis of microbiological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial load of six main periodontal pathogens
Bacterial load mean of six main periodontal pathogens expressed as number after a polymerase chain reaction count
Measured: November 16th 2016
Prevalence of six main periodontal pathogens
Number of sites presenting a specific pathogen
Measured: 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
Measured: 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
Measured: November 16th 2016
Secondary outcomes (1)
Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans
Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans were compared
Measured: November 16th 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start10 Jun 2016
- Primary completion26 Jul 2016
- Study completion16 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Montevecchi, University of Bologna
- Investigators
- Marco Montevecchi, DDS, Study chair, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786133
- Sponsor's protocol ID
- periopathogensdiabetes
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available when the research will be published
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.
PubMed 34965620
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Subgingival Microbiota in Chronic Periodontitis Patients Affected by Type 2 Diabetes Mellitus: a Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT03786133
- Acronym / sponsor ID
- periopathogensdiabetes
- Conditions
- Chronic Periodontitis, Type 2 Diabetes Mellitus
- Keywords
- Subgingival analysis, Real-time PCR, Comparative study, Chronic Periodontitis, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetics | – | Diagnostic Test: Analysis of microbiological testsAnalysis of microbiological tests in chronic periodontitis patients with type 2 diabetes mellitus |
| non-diabetics | – | Diagnostic Test: Analysis of microbiological testsAnalysis of microbiological tests in chronic periodontitis patients without type 2 diabetes mellitus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of microbiological testsCollection and comparison of microbiological data | Diagnostic test | non-diabetics, type 2 diabetics |
Primary outcome
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
Prevalence of six main periodontal pathogens
Time frame: November 16th 2016
Number of sites presenting a specific pathogen
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
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
1 secondary outcome
Genotypes of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans
Time frame: November 16th 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Derived from this study: PubMed 34965620Montevecchi 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.
- Individual participant dataSharing planned: Yes. Data will be available when the research will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Montevecchi, DDS study chair
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis and Type 2 Diabetes Mellitus, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial load of six main periodontal pathogens (time frame: November 16th 2016). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03786133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.