Clinical trial NCT03005886: The Effect of Periodontal Therapy in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction
Official title: The Effect of Periodontal Therapy on Neopterin and Vascular Cell Adhesion Molecule-1 Levels in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Chronic Periodontitis
Keywords: Periodontitis
Periodontal-systemic disease
Cardiovascular diseases
Gingival crevicular fluid
Acute myocardial infarction
Neopterin
Vascular cell adhesion molecule-1
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Ankara University
First posted: 2016-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 39
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study was to evaluate the effects of periodontal treatment on gingival crevicular fluid (GCF) levels of Neopterin(N) and vascular cell adhesion molecule (VCAM-1) in chronic periodontitis(CP) patients with acute myocardial infarction(AMI) in comparison to systemically healthy CP patients. The investigators' hypothesized that severe CP may play a role in initiating or exacerbating MI and there is an increased risk for AMI among systemically healthy persons affected with severe CP.

Detailed description: There are no studies specifically addressing the altered GCF profile concurrent with the onset of myocardial infarction acutely (i.e. in the first 24h) and no data are currently available about GCF Neopterin and VCAM-1 levels in AMI patients with chronic periodontitis. The present study aimed to assess whether GCF levels of CP patients with AMI have an alteration in GCF levels of Neopterin and VCAM-1, also assessed whether these alterations might be related to treatment of existing periodontitis in AMI patients. A total of 60 subjects (20 CP patients with AMI, 20 systemically healthy CP patients and 20 healthy controls) were included.GCF samples were analyzed baseline and after 3 and 6 months, probing pocket depth(PD), clinical attachment level (CAL),bleeding on probing (BOP) , gingival and plaque (PI) indices were recorded. Neopterin and VCAM-1 levels (concentration and total amount) were determined by enzyme linked immunosorbent assay (ELISA). Baseline periodontal examination of AMI patients and 24-48h GCF collection was carried out in their hospital bed under sufficient illumination using artificial light. Within a time period of 2 months after the proceeding infarction, none of the patients had received periodontal treatment. AMI patients underwent periodontal therapy after the stabilization of their condition with the consent from same cardiologist. Periodontal disease was diagnosed based on the 1999 classification system developed by Armitage, and a preoperative periapical radiograph was taken that provided baseline data in Faculty of Dentistry. Clinical index scores and GCF sampling were recorded before, 3 and 6 months after the periodontal treatment. All selected patients underwent a 2- to 4-week initial therapy, which included comprehensive proper plaque control program, scaling, subgingival curettage and root planning in Department of Periodontology. In all patients a periodontal reevaluation was performed 4 weeks after phase I therapy, to confirm the suitability of the sites for periodontal surgery. Mucoperiosteal flap operation was performed in cases where needed. The blood samples for serum were centrifuged for 10 min at 11.00RPM separating the serum from the cells. The serum samples were then immediately divided into 0.2-0.5ml aliquots and stored at -80°C until required for analysis. Samples were assayed for N and VCAM-1 using quantitative enzyme immunoassays.

Micro-centrifuge tubes, containing periopaper strips with absorbed GCF sample, were allowed to reach room temperature and eluted using a centrifugal method.17 After centrifugation, the strips were removed and the fluid was assayed by ELISA for N and soluble VCAM-1.The levels of N and sVCAM-1 in serum and GCF samples were measured using ELISA kit , . The ELISA procedures were carried out according to the manufacturer's instructions.

Eligibility criteria: Inclusion Criteria:

* None of the patients had received periodontal treatment during the past 6 months and none had received antibiotic medication during the past 3 months.
* AMI+CP and CP groups were regarded as suitable for the study if they were affected by CP and had at least 16 teeth, including at least four molars in different quadrants at least two periodontal pocket at least 5mm in depth, with a minimum of 2mm attachment loss.
* Patients, who met the AMI diagnostic criteria, with or without persistent ST-segment elevation

Exclusion Criteria:

* Patients with neoplasias, liver cirrhosis, HIV infection, chronic renal failure, hypo or hyperparathyroidism, diabetes mellitus, chronic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and Chron's Disease

Primary outcomes:
measure: Concentration and total amount of serum and GCF VCAM-1 and Neopterin
timeFrame: Change from baseline concentration and total amount of serum&GCF sVCAM-1 and Neopterin at 6months.
Secondary outcomes:
measure: Clinical attachment level(CAL)
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
Other outcomes:
measure: Plaque Index
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Gingival Index
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Probing Depth
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Bleeding on probing
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
Locations:
Study officials:
affiliation: Gazi University
name: Zeynep Turgut Çankaya, PhD DDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Ayşen Bodur, PhD DDS
role: STUDY_DIRECTOR
References: