Clinical trial NCT04305171: Effect of Non-surgical Periodontal Treatment on Cardiovascular Risk Markers
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Periodontitis
Keywords: Coronary heart disease, peridontitis,
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 28
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in fibrinogen level between baseline and 3 months after non-surgical periodontal treatment
timeFrame: 3 months after non-surgical periodontal treatment
measure: change in activator inhibitor 1 between baseline and 3 months after non-surgical periodontal treatment
timeFrame: 3 months after non-surgical periodontal treatment
measure: change in C-reactive protein between baseline and 3 months after non-surgical periodontal treatment
timeFrame: 3 months after non-surgical periodontal treatment
measure: change in fibrinogen level between baseline and 6 months after non-surgical periodontal treatment
timeFrame: 6 months after non-surgical periodontal treatment
measure: change in activator inhibitor 1 between baseline and 6 months after non-surgical periodontal treatment
timeFrame: 6 months after non-surgical periodontal treatment
measure: change in C-reactive protein between baseline and 6 months after non-surgical periodontal treatment
timeFrame: 6 months after non-surgical periodontal treatment
Secondary outcomes:
measure: change of bleeding on probing between baseline and 3 months after non-surgical periodontal treatment
timeFrame: 3 months after non-surgical periodontal treatment
measure: change of pocket depth between baseline and 3 months after non-surgical periodontal treatment
timeFrame: 3 months after non-surgical periodontal treatment
measure: change of clinical attachment level between baseline and 3 months after non-surgical periodontal treatment
timeFrame: 3 months after non-surgical periodontal treatment
measure: change of bleeding on probing between baseline and 6 months after non-surgical periodontal treatment
timeFrame: 6 months after non-surgical periodontal treatment
measure: change of pocket depth between baseline and 6 months after non-surgical periodontal treatment
timeFrame: 6 months after non-surgical periodontal treatment
measure: change of clinical attachment level between baseline and 6 months after non-surgical periodontal treatment
timeFrame: 6 months after non-surgical periodontal treatment
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University
state: Bangkok
city: Ratchathewi
country: Thailand
facility: Department of Medicine, Rajavithi Hospital
state: Bangkok
city: Ratchathewi
country: Thailand
facility: Mahidol University Faculty of Dentistry
state: Bangkok
Study officials:
affiliation: Mahidol University Faculty of Dentistry
name: Supanee Rassameemasmaung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.