Bacteria in Dental Plaque and Atheroma Plaque | NCT07100574

Studies
Bacteria in Dental Plaque and Atheroma Plaque

NCT07100574

Sponsor

Istanbul Saglik Bilimleri University

Status

Recruiting

Last Update Posted

Aug 3, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Gingival Inflammation
Dental Plaque
Atheroma Plaque
Oral Bacteria

Interventions

atheroma plaque
dental plaque

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2024Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Mar 30, 2026Estimated

First Submitted Date

Oct 10, 2024

First Submission Date that Met QC Criteria

Aug 1, 2025

First Posted Date

Aug 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2025

Last Update Posted Date

Aug 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ayşe Toraman, associate professor, Istanbul Saglik Bilimleri UniversityPrincipal Investigator

Lead Sponsor

Istanbul Saglik Bilimleri UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients diagnosed with endarterectomy			Other: atheroma plaque Other: dental plaque

Interventions

Name	Type	Description	Arm Group Labels	Other Names
atheroma plaque	Other	During the endarterectomy procedure, samples will be collected for study from some of the atheroma plaques routinely taken for pathology from patients.	Patients diagnosed with endarterectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of bacteria	Subgingival plaque	through study completion, an average of 2 months
Number of bacteria	atheroma plaque	through study completion, an average of 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with endarterectomy
Not receiving chemotherapy
Not having received this treatment before

Exclusion Criteria:

Having systemic infection
Patients with severe heart disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Endearterectomy diagnosed, dentate and edentulous patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ayşe Toraman	Contact	05385025422		draysetoraman@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Sciences University, Hamidiye Faculty of Dentistry, Department of Periodontology	Recruiting	Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis
D003773	Dental Plaque

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003774	Dental Plaque Index

Ancestor Terms

ID	Term
D003753	Dental Health Surveys
D006306	Health Surveys
D011795	Surveys and Questionnaires
D003625	Data Collection

Browse Leaves

Not provided

Browse Branches

Not provided