The Effect of Periodontal Therapy in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction

The Effect of Periodontal Therapy on Neopterin and Vascular Cell Adhesion Molecule-1 Levels in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Chronic Periodontitis
• Intervention / Treatment: Procedure: Periodontal examination; Procedure: GCF sampling; Procedure: phase I therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 39 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMI+CP: GCF sampling,periodontal examination,phase I therapy: Patients, who met the AMI diagnostic criteria with chronic periodontitis. Baseline periodontal examination of AMI patients and 24-48h GCF sampling was carried out in their hospital bed under sufficient illumination using artificial light. Phase I periodontal therapy including comprehensive proper plaque control program, scaling, subgingival curettage and root planning in Department of Periodontology. Mucoperiosteal flap operation was performed in cases where needed.	Procedure: Periodontal examination; periodontal examination included the assessment of plaque index (PI), gingival index(GI), probing depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL). All subjects underwent a periodontal examination performed by the same periodontitis (ZTÇ) Prior to the study, the examiner was calibrated for reproducibility of PD and CAL measurements; Procedure: GCF sampling; GCF samples were collected using commercially available periopaper . The sample site was gently air-dried and all supragingival plaque was removed. The area was carefully isolated with cotton rolls and a saliva ejector was used to prevent the samples from being contaminated by saliva. The paper strips were inserted into the pockets until slight resistance was felt and left in place for 30s.; Procedure: phase I therapy; comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning
Active Comparator: Chronic Periodontitis (CP); GCF sampling,periodontal examination,phase I therapy: Systemically healthy chronic periodontitis patients.Phase I periodontal therapy including comprehensive proper plaque control program, scaling, subgingival curettage and root planning in Department of Periodontology.Mucoperiosteal flap operation was performed in cases where needed.	Procedure: Periodontal examination; periodontal examination included the assessment of plaque index (PI), gingival index(GI), probing depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL). All subjects underwent a periodontal examination performed by the same periodontitis (ZTÇ) Prior to the study, the examiner was calibrated for reproducibility of PD and CAL measurements; Procedure: GCF sampling; GCF samples were collected using commercially available periopaper . The sample site was gently air-dried and all supragingival plaque was removed. The area was carefully isolated with cotton rolls and a saliva ejector was used to prevent the samples from being contaminated by saliva. The paper strips were inserted into the pockets until slight resistance was felt and left in place for 30s.; Procedure: phase I therapy; comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning
Sham Comparator: Healthy controls; clinically healthy individuals not having any periodontal and systemic diseases history.Comprehensive medical and periodontal examination to confirm that they did not have systemic and periodontal diseases	Procedure: Periodontal examination; periodontal examination included the assessment of plaque index (PI), gingival index(GI), probing depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL). All subjects underwent a periodontal examination performed by the same periodontitis (ZTÇ) Prior to the study, the examiner was calibrated for reproducibility of PD and CAL measurements; Procedure: GCF sampling; GCF samples were collected using commercially available periopaper . The sample site was gently air-dried and all supragingival plaque was removed. The area was carefully isolated with cotton rolls and a saliva ejector was used to prevent the samples from being contaminated by saliva. The paper strips were inserted into the pockets until slight resistance was felt and left in place for 30s.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration and total amount of serum and GCF VCAM-1 and Neopterin	Using the standards included with the Enzyme-Linked ImmunoSorbent Assay (ELISA) kit. The concentrations of Neopterin and sVCAM-1 were expressed as ng/ml. Total amounts were also calculated by multiplying concentrations and GCF volumes(ml) and expressed as ng.	Change from baseline concentration and total amount of serum&GCF sVCAM-1 and Neopterin at 6months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level(CAL)	CAL was calculated as the distance from cemento-enamel junction to bottom of gingival sulcus.	Baseline, 3 and 6 months after initial periodontal treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	Plaque Index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth.	Baseline, 3 and 6 months after initial periodontal treatment
Gingival Index	Gingival Index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth.	Baseline, 3 and 6 months after initial periodontal treatment
Probing Depth	PD was recorded as the distance from the gingival margin to the most apical part of the sulcus.	Baseline, 3 and 6 months after initial periodontal treatment
Bleeding on probing	BOP is a widely used criterion to diagnose inflammation	Baseline, 3 and 6 months after initial periodontal treatment

Collaborators and Investigators

• Sponsor: Gazi University
• Collaborators: Ankara University
• Investigators: Principal Investigator: Zeynep Turgut Çankaya, PhD DDs, Gazi University; Study Director: Ayşen Bodur, PhD DDS, Gazi University

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 26, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Periodontitis; Cardiovascular diseases; Acute myocardial infarction; Gingival crevicular fluid; Neopterin; Periodontal-systemic disease; Vascular cell adhesion molecule-1
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Myocardial Infarction; Infarction; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: 03/2006-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Clinical measurement records of periodontal and medical protocols can be shared with other researches. Researches should send an e-mail to principal investigator.
• IPD Sharing Time Frame: The data will become available after the study paper published for one year period.
• IPD Sharing Access Criteria: The statistical analysis in the published paper will be shared
• IPD Sharing Supporting Information Type: SAP