NCT04305171

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

February 27, 2020

Last Update Submit

March 10, 2020

Conditions

Coronary Heart DiseasePeriodontitis

Keywords

Coronary heart disease, peridontitis,

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (6)

  • change of bleeding on probing between baseline and 3 months after non-surgical periodontal treatment

    3 months after non-surgical periodontal treatment

  • change of pocket depth between baseline and 3 months after non-surgical periodontal treatment

    3 months after non-surgical periodontal treatment

  • change of clinical attachment level between baseline and 3 months after non-surgical periodontal treatment

    3 months after non-surgical periodontal treatment

  • change of bleeding on probing between baseline and 6 months after non-surgical periodontal treatment

    6 months after non-surgical periodontal treatment

  • change of pocket depth between baseline and 6 months after non-surgical periodontal treatment

    6 months after non-surgical periodontal treatment

  • +1 more secondary outcomes

Study Arms (4)

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

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

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

non-coronary heart disease patients without periodontitis

Non-periodontitis classified as having PD ≤ 3 mm.

Procedure: non-surgical periodontal treatment

Interventions

non-surgical periodontal treatmentPROCEDURE

scaling and root planing, home care instruction

coronary heart disease patients with periodontitiscoronary heart disease patients without periodontitisHDnon-coronary heart disease patients with periodontitisnon-coronary heart disease patients without periodontitis

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Department of Medicine, Rajavithi Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

Mahidol University Faculty of Dentistry

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 36194420DERIVED

MeSH Terms

Conditions

Coronary DiseasePeriodontitis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Supanee Rassameemasmaung, PhD

    Mahidol University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 12, 2020

Study Start

April 6, 2018

Primary Completion

January 31, 2020

Study Completion

February 20, 2020

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

TH(3)