NCT07412795

Brief Summary

The goal of this clinical study is to learn whether gum treatment can improve heart health. Researchers will compare blood markers related to heart disease before and after routine gum treatment. The main questions this study aims to answer are: Is gum disease a risk factor for heart disease? Can treating gum disease lower the risk of heart disease? Adults with stable angina (a type of heart disease) and adults without heart disease may take part in this study. All participants will receive routine, non-surgical gum treatment, which is a standard dental care procedure. This includes professional cleaning to remove plaque and tartar from the teeth and practical education on tooth brushing and cleaning between the teeth. The treatment will be performed by a single researcher and completed in one visit within about one hour. Participants will: Provide a blood sample before gum treatment Receive routine, non-surgical gum treatment Return after three months for a follow-up visit Provide a second blood sample This study does not involve experimental drugs or devices. Participation is voluntary, and there is no cost to participants. The results may help researchers better understand how gum health is related to heart health.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 27, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 27, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

Non-surgical Periodontal TreatmentCardiovascular DiseaseCardiovascular Biomarkersstable anginasoluble ST2periodontitisIMA

Outcome Measures

Primary Outcomes (1)

  • Change in serum ischemia-modified albumin (IMA) concentration after non-surgical periodontal therapy

    Serum ischemia-modified albumin (IMA) concentration measured in nanograms per milliliter (ng/mL) using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. Assessed at baseline and 3 months after non-surgical periodontal therapy.

    Baseline and 3 months

Secondary Outcomes (1)

  • Change in serum soluble suppression of tumorigenicity 2(sST2) concentration after non-surgical periodontal therapy

    Baseline and 3 months

Study Arms (3)

Stable angina and periodontitis group (SAP group)

EXPERIMENTAL

Individuals diagnosed with stable angina and periodontitis who will receive non-surgical

Procedure: Non-surgical periodontal therapy (scaling and root planing)

Periodontitis group (P group)

EXPERIMENTAL

Cardiovascularly healthy individuals diagnosed with periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing.

Procedure: Non-surgical periodontal therapy (scaling and root planing)

Control group (C group)

ACTIVE COMPARATOR

Periodontally and cardiovascularly healthy individuals who will receive routine professional dental cleaning and standardized oral hygiene instruction.

Procedure: Non-surgical periodontal therapy (Professional dental cleaning)

Interventions

Non-surgical periodontal therapy will include full-mouth scaling and root planing performed using hand instruments and/or ultrasonic devices to remove supra- and subgingival plaque and calculus.

Periodontitis group (P group)Stable angina and periodontitis group (SAP group)

Supragingival calculus and plaque removal with standardized oral hygiene instruction.

Control group (C group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to participate in the study and provide written informed consent
  • Age 18 years or older
  • No periodontal treatment within the past 6 months
  • No use of local or systemic antibiotics within the past 3 months

You may not qualify if:

  • Unwillingness to participate in the study or to provide informed consent
  • Age under 18 years
  • Use of local or systemic antibiotics for the treatment of widespread infection
  • within the past 3 months
  • Receipt of periodontal treatment within the past 6 months
  • Pregnancy or lactation (for female participants)
  • History of acute myocardial infarction within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55270, Turkey (Türkiye)

Location

Related Publications (2)

  • Karci B, Savas HB. Evaluation of thiol/disulfide homeostasis and ischemia modified albumin as potential markers for periodontitis. BMC Oral Health. 2025 Apr 10;25(1):519. doi: 10.1186/s12903-025-05875-w.

    PMID: 40211225BACKGROUND
  • Yilmaz M, He Q, Demir E, Terasjarvi J, Gursoy UK. Salivary IL-33 and sST2 levels in relation to TLR2 rs111200466 polymorphism and periodontitis. Oral Dis. 2024 May;30(4):2254-2261. doi: 10.1111/odi.14675. Epub 2023 Jul 10.

    PMID: 37427857BACKGROUND

MeSH Terms

Conditions

Angina, StablePeriodontitisCardiovascular Diseases

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Sena Altintas, DDS

    Ondokuz Mayis University Department of Periodontology

    PRINCIPAL INVESTIGATOR
  • Feyza Otan Ozden, Professor

    Ondokuz Mayis University Department of Periodontology

    STUDY DIRECTOR

Central Study Contacts

Sena Altintas, DDS

CONTACT

Feyza Otan Ozden, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Stable angina and periodontitis group (SAP group): Individuals diagnosed with stable angina and periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing. Periodontitis group (P group): Cardiovascularly healthy individuals diagnosed with periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing. Control group (C group): Periodontally and cardiovascularly healthy individuals who will receive routine professional dental cleaning and standardized oral hygiene instruction.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 17, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

August 5, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

The decision to not share individual participant data (IPD) is based on ethical considerations, institutional policies, and the need to protect participant privacy and confidentiality. The collected data will only be used for the purposes of this study and will not be made available for external use.

Locations