Gingival InflammationNCT07100574
Bacteria in Dental Plaque and Atheroma Plaque
An observational study of Gingival Inflammation and Dental Plaque, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is considered a focus of infection where oral bacteria, bacterial by-products or inflammatory mediators can interact with other parts of the organism via the blood. Periodontal pathogen components such as DNA, RNA or specific antigens of P. gingivalis, Aggregatibacter actinomycetemcomitans (A. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gingival Inflammation, Dental Plaque, Atheroma Plaque
- What is being tested?
- atheroma plaque and dental plaque
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Adult, Older adult
Study population: Endearterectomy diagnosed, dentate and edentulous patients
Who may be able to join
- Diagnosed with endarterectomy
- Not receiving chemotherapy
- Not having received this treatment before
Who cannot join
- Having systemic infection
- Patients with severe heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University, Hamidiye Faculty of Dentistry, Department of Periodontology
Istanbul
Ayşe Toraman, 05385025422, draysetoraman@gmail.com
About this study
Periodontitis is considered a focus of infection where oral bacteria, bacterial by-products or inflammatory mediators can interact with other parts of the organism via the blood. Periodontal pathogen components such as DNA, RNA or specific antigens of P. gingivalis, Aggregatibacter actinomycetemcomitans (A. actinomycetemcomitans), Treponema denticola (T. denticola), Fusobacterium nucleatum (F. nucleatum) or Campylobacter rectus have been isolated from different tissues such as atheroma plaques, placenta, amniotic sac and respiratory tract. It has been reported that periodontitis may contribute to endothelial dysfunction leading to the formation of atherosclerosis.
Read the detailed description
Periodontitis is considered a focus of infection where oral bacteria, bacterial by-products or inflammatory mediators can interact with other parts of the organism via the blood. Periodontal pathogen components such as DNA, RNA or specific antigens of P. gingivalis, Aggregatibacter actinomycetemcomitans (A. actinomycetemcomitans), Treponema denticola (T. denticola), Fusobacterium nucleatum (F. nucleatum) or Campylobacter rectus have been isolated from different tissues such as atheroma plaques, placenta, amniotic sac and respiratory tract. It has been reported that periodontitis may contribute to endothelial dysfunction leading to the formation of atherosclerosis.
Severe chronic generalized periodontitis may result in systemic inflammation and endothelial dysfunction. Periodontal bacteria produce endotoxins in the form of lipopolysaccharide (LPS). Circulating LPS causes an early systemic inflammatory response in the intima.
The aim of this study is to assess the relationship between bacteria in atheroma plaque, and dental plaque in patients grouped using the new periodontal classification. In addition, the relationship between demographic findings and bacterial count and frequency will be evaluated.
- Conditions
- Gingival Inflammation, Dental Plaque, Atheroma Plaque, Oral Bacteria
- Being tested
- atheroma plaque, dental plaque
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atheroma plaqueOther
During the endarterectomy procedure, samples will be collected for study from some of the atheroma plaques routinely taken for pathology from patients.
dental plaqueOther
Subgingival plaque samples will be collected from patients before the endarterectomy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with endarterectomy | Not described Receives: Other: atheroma plaque; Other: dental plaque |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bacteria
Subgingival plaque
Measured: through study completion, an average of 2 months
Number of bacteria
atheroma plaque
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start10 Dec 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival InflammationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Toraman, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100574
- Sponsor's protocol ID
- 1417
- Status last verified
- Aug 2025
- First submitted
- 10 Oct 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteria in Dental Plaque and Atheroma Plaque
- ClinicalTrials.gov ID
- NCT07100574
- Acronym / sponsor ID
- 1417
- Conditions
- Gingival Inflammation, Dental Plaque, Atheroma Plaque, Oral Bacteria
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 3 Aug 2025 (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.
Periodontitis is considered a focus of infection where oral bacteria, bacterial by-products or inflammatory mediators can interact with other parts of the organism via the blood. Periodontal pathogen components such as DNA, RNA or specific antigens of P. gingivalis, Aggregatibacter actinomycetemcomitans (A. actinomycetemcomitans), Treponema denticola (T. denticola), Fusobacterium nucleatum (F. nucleatum) or Campylobacter rectus have been isolated from different tissues such as atheroma plaques, placenta, amniotic sac and respiratory tract. It has been reported that periodontitis may contribute to endothelial dysfunction leading to the formation of atherosclerosis.
Detailed description
Periodontitis is considered a focus of infection where oral bacteria, bacterial by-products or inflammatory mediators can interact with other parts of the organism via the blood. Periodontal pathogen components such as DNA, RNA or specific antigens of P. gingivalis, Aggregatibacter actinomycetemcomitans (A. actinomycetemcomitans), Treponema denticola (T. denticola), Fusobacterium nucleatum (F. nucleatum) or Campylobacter rectus have been isolated from different tissues such as atheroma plaques, placenta, amniotic sac and respiratory tract. It has been reported that periodontitis may contribute to endothelial dysfunction leading to the formation of atherosclerosis.
Severe chronic generalized periodontitis may result in systemic inflammation and endothelial dysfunction. Periodontal bacteria produce endotoxins in the form of lipopolysaccharide (LPS). Circulating LPS causes an early systemic inflammatory response in the intima.
The aim of this study is to assess the relationship between bacteria in atheroma plaque, and dental plaque in patients grouped using the new periodontal classification. In addition, the relationship between demographic findings and bacterial count and frequency will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with endarterectomy | – | Other: atheroma plaque, Other: dental plaque |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Endearterectomy diagnosed, dentate and edentulous patients
Key inclusion criteria (3 listed)
- Diagnosed with endarterectomy
- Not receiving chemotherapy
- Not having received this treatment before
Key exclusion criteria (2 listed)
- Having systemic infection
- Patients with severe heart disease
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 |
|---|---|---|
| atheroma plaqueDuring the endarterectomy procedure, samples will be collected for study from some of the atheroma plaques routinely taken for pathology from patients. | Other | Patients diagnosed with endarterectomy |
| dental plaqueSubgingival plaque samples will be collected from patients before the endarterectomy procedure. | Other | Patients diagnosed with endarterectomy |
Primary outcome
Number of bacteria
Time frame: through study completion, an average of 2 months
Subgingival plaque
Number of bacteria
Time frame: through study completion, an average of 2 months
atheroma plaque
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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 Gingival Inflammation and Dental Plaque, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Toraman (05385025422, draysetoraman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bacteria (time frame: through study completion, an average of 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.