Salivary Angiotensin-Converting Enzyme and Periodontal Disease in Cardiovascular Disease

NCT07721428 | Completed

• 2 other identifiers: 424 (2021-02-25)TDH-2021-8336
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn whether the renin-angiotensin system, measured by angiotensin-converting enzyme (ACE) and angiotensin-converting enzyme 2 (ACE2) in saliva and blood, is associated with periodontal disease severity in adults undergoing cardiovascular evaluation. The main questions it aims to answer are:

• Are salivary and blood ACE and ACE2 levels different according to periodontal disease severity?
• Do salivary ACE and ACE2 levels reflect the corresponding blood levels?
• Are ACE and ACE2 levels related to clinical measures of periodontal disease? Participants will:
• Complete medical and dental history assessments.
• Undergo a comprehensive periodontal examination, including measurements of plaque, gingival inflammation, bleeding on probing, probing pocket depth, clinical attachment loss, and the number of remaining teeth.
• Provide saliva and blood samples for laboratory measurement of ACE and ACE2.

Conditions

Periodontal Disease; Cardiovascular Disease

Keywords

Periodontitis; Cardiovascular disease; Saliva; Angiotensin-converting enzyme; Angiotensin-converting enzyme 2

Outcome Measures

Primary Outcomes (1)

• Salivary angiotensin-converting enzyme (ACE) concentration

  Salivary angiotensin-converting enzyme (ACE) concentration (U/L), measured using enzyme-linked immunosorbent assay (ELISA), and compared across periodontal disease severity groups classified as gingivitis, Stage I/II periodontitis, and Stage III/IV periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.

  Baseline (single study visit)

Secondary Outcomes (4)

• Serum angiotensin-converting enzyme (ACE) concentration

  Baseline (single study visit)

• Salivary angiotensin-converting enzyme 2 (ACE2) concentration

  Baseline

• Serum angiotensin-converting enzyme 2 (ACE2) concentration

  Baseline

• Serum and salivary ACE/ACE2 ratio

  Baseline

Study Arms (1)

Cardiovascular Disease (Adults with angiographically confirmed cardiovascular disease.)

Adults were included in the observational study cohort. Participants underwent periodontal assessment and were classified according to periodontal status as gingivitis, Stage 1/2 periodontitis, or Stage 3/4 periodontitis. Saliva and blood samples were collected for analysis of ACE and ACE2 biomarkers.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between March 1, 2021, and June 12, 2021, a total of 113 symptomatic adults attending the Cardiology and Periodontology clinics of Süleyman Demirel University underwent diagnostic coronary angiography because of suspected myocardial ischemia based on clinical symptoms or non-invasive test findings. Significant coronary artery disease was defined as ≥50% luminal stenosis in at least one major epicardial coronary artery, as determined by visual assessment using the standard Judkins technique. Of the 113 individuals screened, 24 were excluded because they did not meet the eligibility criteria, and 13 declined to participate. Consequently, 76 participants were enrolled and underwent a comprehensive periodontal examination, along with the collection of unstimulated saliva and venous blood for biochemical analyses. Before statistical analyses, participants were classified according to the 2018 periodontal classification as gingivitis, Stage 1/2 periodontitis, or Stage 3/4 periodontitis.

You may qualify if:

• Adults aged 18 years or older.
• Having at least 20 natural teeth.
• Diagnosis of cardiovascular disease confirmed by coronary angiography.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Fewer than 20 natural teeth.
• Pregnancy or lactation.
• Periodontal treatment within the previous 6 months.
• Antibiotic or anti-inflammatory drug use within the previous 3 months.
• Presence of systemic inflammatory, autoimmune, or infectious diseases that could affect periodontal inflammation.
• History of malignancy.
• Requirement for antibiotic prophylaxis before periodontal examination.
• Refusal or inability to provide saliva or blood samples.
• Having a history of COVID-19 infection where less than 2 months had elapsed since the last positive RT-PCR test result

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Süleyman Demirel University

Isparta, Merkez, 32200, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aliquots of unstimulated whole saliva and serum samples collected from study participants are retained for future analyses of non-genetic biomarkers. No DNA extraction or genetic analyses are planned.

MeSH Terms

Conditions

Periodontal Diseases; Cardiovascular Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 23, 2026
• Study Start: March 1, 2021
• Primary Completion: June 12, 2021
• Study Completion: June 1, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

TU (1)