NCT07591844

Brief Summary

This study aims to evaluate the effect of non-surgical periodontal therapy on serum asprosin levels in patients with stable angina and periodontitis. Asprosin is a novel metabolic biomarker reported to have potential protective roles in cardiovascular diseases and inflammatory processes. The study also investigates the relationship between periodontal parameters and serum asprosin levels before and after periodontal therapy.

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
5mo left

Started May 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

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Oct 2026

First Submitted

Initial submission to the registry

May 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

Non-surgical periodontal treatmentcardiovascular diseasestable anginaasprosinperiodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in serum asprosin levels after non-surgical periodontal therapy

    Serum asprosin concentrations (ng/mL) will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit at baseline and 3 months following non-surgical periodontal therapy.

    Baseline and 3 months

Study Arms (3)

Stable angina and periodontitis group (SAP group)

EXPERIMENTAL

Individuals with angiographically confirmed stable angina and periodontitis who will receive non-surgical periodontal therapy, including scaling and root planing

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

Periodontitis group (P group)

EXPERIMENTAL

Individuals with angiographically confirmed cardiovascular health and 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 healthy individuals with angiographically confirmed absence of coronary artery disease 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 (1)

  • Gul SNS, Birdal O, Laloglu E. Serum asprosin levels are increased in patients with periodontitis and ST-segment elevation myocardial infarction and correlated with periodontal parameters: A case-control study. J Periodontal Res. 2024 Apr;59(2):259-266. doi: 10.1111/jre.13210. Epub 2023 Nov 20.

    PMID: 37984462BACKGROUND

MeSH Terms

Conditions

Angina, StablePeriodontitisCardiovascular DiseasesArachnodactyly

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesLimb Deformities, CongenitalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

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, Prof.

    Ondokuz Mayis University Department of Periodontology

    STUDY DIRECTOR

Central Study Contacts

Sena Altintas, DDS

CONTACT

Feyza Otan Ozden, Prof.

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

May 11, 2026

First Posted

May 18, 2026

Study Start

May 20, 2026

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

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