Effect of Non-surgical Periodontal Treatment on Cardiovascular Risk Markers

Effect of Non-surgical Periodontal Treatment on Plasma Fibrinogen, Plasminogen Activator Inhibitor 1 and C-reactive Protein Levels in Cardiovascular Disease Patients With Periodontitis

The research question was to investigate whether non-surgical periodontal therapy could reduce cardiovascular risk markers in Coronary heart disease (CHD) patients.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Coronary Heart Disease
• Intervention / Treatment: Procedure: non-surgical periodontal treatment

Detailed Description

CHD patients or non-CHD with or without periodontitis were included. They were provided with non-surgical periodontal therapy (NSPT). Periodontal parameters and cardiovascular risk markers were measured at baseline and 3 months and 6 months after NSPT.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
    • Ratchathewi, Bangkok, Thailand, 10400
      • Department of Medicine, Rajavithi Hospital
    • Ratchathewi, Bangkok, Thailand, 10400
      • Mahidol University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatients who came to the Hospital for Tropical Medicine, Faculty of Tropical Medicine, Mahidol University or Rajavithi Hospital, Thailand

Description

Inclusion Criteria:

• non-CHD or CHD (at least 50% diameter stenosis in at least one coronary artery and clinically stable with absence of any potentially confounding inflammatory conditions for at least 6 months)
• had at least 14 natural teeth excluding third molars

Exclusion Criteria:

• received anticoagulant drugs
• had chronic conditions (e.g. diabetes mellitus, rheumatoid arthritis, malignancy, autoimmune disease) or acute conditions (e.g. trauma, surgery) or medications known to affect systemic inflammatory markers (e.g. antibiotics, immunosuppressive, contraceptives) within 3 months
• pregnancy or lactation
• presence or history of other infections
• periodontal treatment within 6 months
• tooth extractions within 2 months prior to the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
coronary heart disease patients with periodontitis; Coronary heart disease patients confirmed through coronary angiography as having at least 50% diameter stenosis in at least one coronary artery and clinically stable with the absence of any potentially confounding inflammatory conditions for at least 6 months. Periodontitis classified as havingbleeding on probing (BOP), pocket depth (PD) > 4 mm, clinical attachment level (CAL) ≥ 5 mm and radiographic evidence of bone loss were presented at the same site of at least 4 teeth.	Procedure: non-surgical periodontal treatment; scaling and root planing, home care instruction
coronary heart disease patients without periodontitisHD; Coronary heart disease patients confirmed through coronary angiography as having at least 50% diameter stenosis in at least one coronary artery and clinically stable with the absence of any potentially confounding inflammatory conditions for at least 6 months. Non-periodontitis classified as having PD ≤ 3 mm.	Procedure: non-surgical periodontal treatment; scaling and root planing, home care instruction
non-coronary heart disease patients with periodontitis; Periodontitis classified as havingbleeding on probing (BOP), pocket depth (PD) > 4 mm, clinical attachment level (CAL) ≥ 5 mm and radiographic evidence of bone loss were presented at the same site of at least 4 teeth.	Procedure: non-surgical periodontal treatment; scaling and root planing, home care instruction
non-coronary heart disease patients without periodontitis; Non-periodontitis classified as having PD ≤ 3 mm.	Procedure: non-surgical periodontal treatment; scaling and root planing, home care instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in fibrinogen level between baseline and 3 months after non-surgical periodontal treatment	change in plasma fibrinogen level (pg/mL)	3 months after non-surgical periodontal treatment
change in activator inhibitor 1 between baseline and 3 months after non-surgical periodontal treatment	change in activator inhibitor 1 level (pg/mL)	3 months after non-surgical periodontal treatment
change in C-reactive protein between baseline and 3 months after non-surgical periodontal treatment	change in C-reactive protein level (mg/L)	3 months after non-surgical periodontal treatment
change in fibrinogen level between baseline and 6 months after non-surgical periodontal treatment	change in plasma fibrinogen level (pg/mL)	6 months after non-surgical periodontal treatment
change in activator inhibitor 1 between baseline and 6 months after non-surgical periodontal treatment	change in activator inhibitor 1 level (pg/mL)	6 months after non-surgical periodontal treatment
change in C-reactive protein between baseline and 6 months after non-surgical periodontal treatment	change in C-reactive protein level (mg/L)	6 months after non-surgical periodontal treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of bleeding on probing between baseline and 3 months after non-surgical periodontal treatment	percetage of sites with bleeding on probing	3 months after non-surgical periodontal treatment
change of pocket depth between baseline and 3 months after non-surgical periodontal treatment	Depth of periodontal pocket in millimeters	3 months after non-surgical periodontal treatment
change of clinical attachment level between baseline and 3 months after non-surgical periodontal treatment	Level of clinical attachment in millimeters	3 months after non-surgical periodontal treatment
change of bleeding on probing between baseline and 6 months after non-surgical periodontal treatment	percetage of sites with bleeding on probing	6 months after non-surgical periodontal treatment
change of pocket depth between baseline and 6 months after non-surgical periodontal treatment	Depth of periodontal pocket in millimeters	6 months after non-surgical periodontal treatment
change of clinical attachment level between baseline and 6 months after non-surgical periodontal treatment	Level of clinical attachment in millimeters	6 months after non-surgical periodontal treatment

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Supanee Rassameemasmaung, PhD, Mahidol University Faculty of Dentistry

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Coronary heart disease, peridontitis,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Periodontitis
• Other Study ID Numbers: MU-DT/PY-IRB 2018/022.0504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No