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

NCT ID: NCT03005886

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2010-08-31

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.

Conditions

Myocardial Infarction; Chronic Periodontitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Periodontal examination

Intervention Type: PROCEDURE

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

GCF sampling

Intervention Type: PROCEDURE

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.

phase I therapy

Intervention Type: PROCEDURE

comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning

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.

Group Type: ACTIVE_COMPARATOR

Periodontal examination

Intervention Type: PROCEDURE

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

GCF sampling

Intervention Type: PROCEDURE

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.

phase I therapy

Intervention Type: PROCEDURE

comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning

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

Group Type: SHAM_COMPARATOR

Periodontal examination

Intervention Type: PROCEDURE

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

GCF sampling

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

phase I therapy

comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 39 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara University

OTHER

Sponsor Role: collaborator

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Turgut Çankaya

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Turgut Çankaya, PhD DDs

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Ayşen Bodur, PhD DDS

Role: STUDY_DIRECTOR

Gazi University

Other Identifiers

03/2006-30

Identifier Type: -

Identifier Source: org_study_id