Effect of Non-surgical Periodontal Treatment on Cardiovascular Risk Markers

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305171
• Other study ID #: MU-DT/PY-IRB 2018/022.0504
• Status: Completed
• Start date: April 6, 2018
• Est. completion date: February 20, 2020

Study information

• Verified date: March 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 20, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Periodontitis

Intervention

Procedure:
• non-surgical periodontal treatment
scaling and root planing, home care instruction

Locations

Country	Name	City	State
Thailand	Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University	Ratchathewi	Bangkok
Thailand	Department of Medicine, Rajavithi Hospital	Ratchathewi	Bangkok
Thailand	Mahidol University Faculty of Dentistry	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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