Periodontal InflammationNCT07165054
Periodontal Pathogens and Atherom Plaque The Number of Mitochondrial DNA Copies
An observational study of Periodontal Inflammation and Biofilm, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a chronic inflammatory disease of the tooth-supporting tissues characterized by the constant interaction of microorganisms in subgingival plaque and host defense mechanisms. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Periodontal Inflammation, Biofilm, Endothelial Dysfunction
- What is being tested?
- atheroma plaque and Dental plaque
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 1 Dec 2025
- 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 25 to 90 years
- All sexes
- No healthy volunteers
- 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.
Turkey (Türkiye)1 site
Health Sciences University, Hamidiye Faculty of Dentistry, Department of Periodontology
Istanbul
About this study
Periodontitis is a chronic inflammatory disease of the tooth-supporting tissues characterized by the constant interaction of microorganisms in subgingival plaque and host defense mechanisms. Periodontitis is considered a focus of infection caused by oral bacteria, bacterial byproducts, or inflammatory mediators that can interact with other parts of the body via the bloodstream.
Read the detailed description
Periodontitis is a chronic inflammatory disease of the tooth-supporting tissues characterized by the constant interaction of microorganisms in subgingival plaque and host defense mechanisms. Periodontitis is considered a focus of infection caused by oral bacteria, bacterial byproducts, or inflammatory mediators that can interact with other parts of the body via the bloodstream.
Periodontal bacteria produce endotoxins in the form of lipopolysaccharide (LPS). Circulating LPS reacts with Toll-like receptors, promoting the production of reactive oxygen species and phagocytosis in the intima layer. Oxidative stress has been reported to be associated with mtDNA copy number.
- Being tested
- atheroma plaque, Dental plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atheroma plaqueOther
Before 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.
Bacterial frequency (%)
The percentage of bacteria in the red complex in atheroma plaque and dental plaque is evaluated using polymerase chain reaction methods.
Measured: Months 6-9 of the study
Secondary outcomes (2)
Changes in mtDNA copy number (number)
Evaluation by means of quantitative polymerase chain reaction of mtDNA copy number in atheroma plaque
Measured: Months 6-9 of the study
periodontal healths (mm)
Evaluation by means of periodontal indices such as PI, GI, BOP, PD.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start10 Apr 2025
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
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 Periodontal 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
- 51 participants (actual)
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
- NCT07165054
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toraman A, Saglam E, Toraman E, Ketenciler S, Koseoglu S. Red-Complex Bacterial DNA in Carotid Atheroma of Dentate and Long-Term Edentulous Patients and Its Association With Mitochondrial DNA Copy Number. Oral Dis. 2026 Jul 16. doi: 10.1111/odi.70431. Online ahead of print.
PubMed 42464421
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Pathogens and Atherom Plaque The Number of Mitochondrial DNA Copies
- ClinicalTrials.gov ID
- NCT07165054
- Acronym / sponsor ID
- 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 10 Sep 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 a chronic inflammatory disease of the tooth-supporting tissues characterized by the constant interaction of microorganisms in subgingival plaque and host defense mechanisms. Periodontitis is considered a focus of infection caused by oral bacteria, bacterial byproducts, or inflammatory mediators that can interact with other parts of the body via the bloodstream.
Detailed description
Periodontitis is a chronic inflammatory disease of the tooth-supporting tissues characterized by the constant interaction of microorganisms in subgingival plaque and host defense mechanisms. Periodontitis is considered a focus of infection caused by oral bacteria, bacterial byproducts, or inflammatory mediators that can interact with other parts of the body via the bloodstream.
Periodontal bacteria produce endotoxins in the form of lipopolysaccharide (LPS). Circulating LPS reacts with Toll-like receptors, promoting the production of reactive oxygen species and phagocytosis in the intima layer. Oxidative stress has been reported to be associated with mtDNA copy number.
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
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- 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 plaqueBefore 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
Bacterial frequency (%)
Time frame: Months 6-9 of the study
The percentage of bacteria in the red complex in atheroma plaque and dental plaque is evaluated using polymerase chain reaction methods.
2 secondary outcomes
Changes in mtDNA copy number (number)
Time frame: Months 6-9 of the study
periodontal healths (mm)
Time frame: 8 months
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 30 Jan 2026.
- Derived from this study: PubMed 42464421Toraman A, Saglam E, Toraman E, Ketenciler S, Koseoglu S. Red-Complex Bacterial DNA in Carotid Atheroma of Dentate and Long-Term Edentulous Patients and Its Association With Mitochondrial DNA Copy Number. Oral Dis. 2026 Jul 16. doi: 10.1111/odi.70431. Online ahead of print.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontal Inflammation and Biofilm, 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: finished, as of the sponsor's last update on 30 Jan 2026. 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?
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 frequency (%) (time frame: Months 6-9 of the study). 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 NCT07165054, 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 30 Jan 2026.