NCT04303351

Brief Summary

This study aimed to evaluate the association between periodontitis and atherosclerosis of the cerebral vasculature in the Chinese population.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

March 8, 2020

Last Update Submit

March 10, 2020

Conditions

Keywords

arterial stenosisperiodontitisatherosclerosisrisk factors

Outcome Measures

Primary Outcomes (1)

  • The relationship between atherosclerotic-related stenosis in different brain arteries and tooth loss categories

    The arteries of the brains will be partitioned into the following segments: common carotid artery (CCA), internal carotid arteries (ICA, C1-C7), the external carotid artery (ECA), the anterior cerebral artery (ACA, A1-A2), the middle cerebral artery (MCA, M1-M2), the posterior cerebral artery (PCA), the basilar artery (BA), the vertebral artery (VA,V1-V4) and the subclavicular artery (SUB) .The chi-square test and Fisher's exact test will be used, as appropriate, to estimate the relationship between tooth loss and stenosis distributed in different branches

    1 day

Secondary Outcomes (1)

  • The relationship between the severity of artery stenosis and tooth loss categories

    1 day

Study Arms (4)

0-9 missing teeth

participants with 0-9 missing teeth

10-19 missing teeth

participants with 10-19 missing teeth

23-31 missing teeth

participants with 23-31 missing teeth

Edentulous

participants with no teeth

Eligibility Criteria

Age18 Years - 98 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population are people who underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine from April 2020 to April 2022 and meat the inclusion and exclusion criteria

You may qualify if:

  • subjects who underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine from April 2020 to December 2021
  • subjects who voluntarily participated in this study and provided informed consent.

You may not qualify if:

  • intracranial and extracranial artery stenosis caused by vascular inflammation, systemic connective tissue disease, and muscle fibre structure hypoplasia
  • inability to cooperate with the investigation
  • intracranial aneurysm and cerebral arteriovenous malformation confirmed by cerebral angiography
  • receipt of periodontal treatment in the previous 24 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

All the blood samples will be stored in the biological resource centre of the our research centre after written informed consent obtained from all subjects who voluntarily participated in this clinical study.

MeSH Terms

Conditions

PeriodontitisAtherosclerosis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Jianwen Guo, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 11, 2020

Study Start

April 1, 2020

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

March 11, 2020

Record last verified: 2020-03