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

NCT03005886 | Completed DMC

• 1 other identifier: 03/2006-30
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocardial Infarction; Chronic Periodontitis

Keywords

Periodontitis; Periodontal-systemic disease; Cardiovascular diseases; Gingival crevicular fluid; Acute myocardial infarction; Neopterin; Vascular cell adhesion molecule-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical attachment level(CAL)

  Baseline, 3 and 6 months after initial periodontal treatment

Other Outcomes (4)

• Plaque Index

  Baseline, 3 and 6 months after initial periodontal treatment

• Gingival Index

  Baseline, 3 and 6 months after initial periodontal treatment

• Probing Depth

  Baseline, 3 and 6 months after initial periodontal treatment

Study Arms (3)

AMI+CP:

EXPERIMENTAL

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; Procedure: GCF sampling; Procedure: phase I therapy

Chronic Periodontitis (CP)

ACTIVE COMPARATOR

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; Procedure: GCF sampling; Procedure: phase I therapy

Healthy controls

SHAM COMPARATOR

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; Procedure: GCF sampling

Interventions

Periodontal examination 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

AMI+CP:; Chronic Periodontitis (CP); Healthy controls

GCF sampling 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.

AMI+CP:; Chronic Periodontitis (CP); Healthy controls

phase I therapy PROCEDURE

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

AMI+CP:; Chronic Periodontitis (CP)

Eligibility Criteria

• Age: 39 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead
• Ankara University: collaborator

MeSH Terms

Conditions

Myocardial Infarction; Chronic Periodontitis; Periodontitis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes

Study Officials

• Zeynep Turgut Çankaya, PhD DDs

  Gazi University

  PRINCIPAL INVESTIGATOR

• Ayşen Bodur, PhD DDS

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 30, 2016
• Study Start: August 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The data will become available after the study paper published for one year period.
• Access Criteria: The statistical analysis in the published paper will be shared