Neutrophil Elastase, Elastase Alpha-1 Proteinase, Periodontitis, Gingival Crevicular Fluid and Acute Coronary Syndrome

NCT04785235 | Completed

• 1 other identifier: 05401018
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

Periodontitis may contribute to vascular damage, resulting in the destabilization of atherosclerotic plaque leading to acute coronary syndrome (ACS). In this study, we explored the effect of non-surgical periodontal treatment (NSPT) on cardiovascular blood biomarkers and gingival crevicular fluid (GCF) Neutrophil Elastase (NE) and α1-proteinase inhibitor (alpha-1PI) levels in periodontitis (P) participants with and without ACS. Medical and dental examinations were performed to diagnose ACS and periodontitis, respectively. Seventeen patients with diagnosis ACS and periodontitis were included in this study, as a test group (Group ACS). Twenty-six, age and sex-matched control patients with periodontitis (Group P) were otherwise systemically healthy. Both groups received NSPT. Plasma levels of cholesterol, triglyceride, high-density lipoprotein (HDL), low-density lipoprotein (LDL), C-reactive protein (CRP), GCF NE activity, and GCF α1-PI levels were measured baseline, at1st and 3rd months after NSPT.

Conditions

Acute Coronary Syndrome; Periodontitis

Outcome Measures

Primary Outcomes (2)

• GCF NE levels

  Change of NE levels in ACS patients after NSPT.

  in 3months

• GCF α1-PI

  Change of GCF α1-PI in ACS patients after NSPT.

  in 3months

Secondary Outcomes (1)

• change in NE / α1-PI rates

  in 3months

Study Arms (2)

ACS

Group ACS: Acute Coronary Syndrome

Procedure: Non-Surgical Periodontal Therapy

Periodontitis

Group P :Periodontitis

Procedure: Non-Surgical Periodontal Therapy

Interventions

Non-Surgical Periodontal Therapy PROCEDURE

ACS; Periodontitis

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The periodontal condition was graded based on the current classification method for periodontal diseases and subjects with localized or generalized periodontitis of stage II or III with grade B or C were selected

You may qualify if:

• Patients diagnosed with both ACS and localized or generalized periodontitis of stage II or III with grade B or C. ACS patients myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI) were hospitalized .
• Unstable angina (UA) was defined as the new onset or a changed pattern of angina over the past 2 months and Canadian Cardiovascular Society (CCS) class IV angina at the time of presentation coinciding with appropriate objective evidence of myocardial ischemia on an electrocardiogram (ECG) or myocardial perfusion imaging. ACS with ST-segment elevation was defined as AMI characterized by: chest pain, radiating or not to the upper extremities, lower jaw, upper back or epigastrium lasting 30 minutes or more, associated or not with sweating, nausea or pallor; presence of ST-segment elevation of 1 mm in two or more contiguous peripheral leads or 2 mm in two or more contiguous precordial leads on electrocardiogram (ECG); and elevation in serum markers of myocardial injury and necrosis (CK, CK-MB) three times their reference value28. Non-ST-segment elevation ACS on ECG was defined as a clinical condition similar to that mentioned above but with chest pain lasting less than 30 minutes, with or without elevation of serum enzyme markers of myocardial injury and necrosis (CK, CK-MB, cardiac troponins I and T). ACS patients were referred to the Department of Periodontology, Faculty of Dentistry, Selcuk University (Konya/Turkey) for periodontal examination in a one- year period.
• Patients diagnosed with localized or generalized periodontitis of stage II or III with grade B or C.
• Twenty-six age and sex-matched patients (43.04±8.35 years) with periodontitis (Group P) otherwise systemically healthy were recruited as control group in the Department of Periodontology, Faculty of Dentistry, Selcuk University (Konya/Turkey).
• metabolic disorders,
• high blood pressure,
• treated with antihypertensive medications,
• periodontal therapy antibiotic treatment until 3 months prior the study. Smoking habits and education status were also recorded. ACS patients take aspirin (1 × 100 mg per day) during 1 month.

Sponsors & Collaborators

• Baskent University: lead
• Selcuk University: collaborator

Related Publications (5)

• Liljestrand JM, Paju S, Pietiainen M, Buhlin K, Persson GR, Nieminen MS, Sinisalo J, Mantyla P, Pussinen PJ. Immunologic burden links periodontitis to acute coronary syndrome. Atherosclerosis. 2018 Jan;268:177-184. doi: 10.1016/j.atherosclerosis.2017.12.007. Epub 2017 Dec 6.

  PMID: 29232563 BACKGROUND

• Bokhari SA, Khan AA, Butt AK, Azhar M, Hanif M, Izhar M, Tatakis DN. Non-surgical periodontal therapy reduces coronary heart disease risk markers: a randomized controlled trial. J Clin Periodontol. 2012 Nov;39(11):1065-74. doi: 10.1111/j.1600-051X.2012.01942.x. Epub 2012 Sep 11.

  PMID: 22966824 BACKGROUND

• Montenegro MM, Ribeiro IWJ, Kampits C, Saffi MAL, Furtado MV, Polanczyk CA, Haas AN, Rosing CK. Randomized controlled trial of the effect of periodontal treatment on cardiovascular risk biomarkers in patients with stable coronary artery disease: Preliminary findings of 3 months. J Clin Periodontol. 2019 Mar;46(3):321-331. doi: 10.1111/jcpe.13085. Epub 2019 Mar 6.

  PMID: 30761568 BACKGROUND

• Ye Z, Cao Y, Miao C, Liu W, Dong L, Lv Z, Iheozor-Ejiofor Z, Li C. Periodontal therapy for primary or secondary prevention of cardiovascular disease in people with periodontitis. Cochrane Database Syst Rev. 2022 Oct 4;10(10):CD009197. doi: 10.1002/14651858.CD009197.pub5.

  PMID: 36194420 DERIVED

• Kayar NA, Ustun K, Gozlu M, Haliloglu S, Alptekin NO. The effects of non-surgical periodontal therapy on neutrophil elastase and elastase alpha-1 proteinase inhibitor levels in GCF in periodontitis patients with or without acute coronary syndrome. Clin Oral Investig. 2021 May;25(5):3329-3338. doi: 10.1007/s00784-021-03838-3. Epub 2021 Mar 9.

  PMID: 33687554 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

gingival crevicular fluid

MeSH Terms

Conditions

Acute Coronary Syndrome; Periodontitis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nilgun Ozlem Alptekin, prof.dr

  Baskent Univercity

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: March 5, 2021
• Study Start: October 15, 2007
• Primary Completion: October 15, 2008
• Study Completion: October 15, 2008
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share