- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04303351
Periodontitis and Atherosclerotic-related Arterial Stenosis
March 10, 2020 updated by: Guangzhou University of Traditional Chinese Medicine
The Relationship Between Periodontitis and Atherosclerotic-related Arterial Stenosis in the Chinese Population
This study aimed to evaluate the association between periodontitis and atherosclerosis of the cerebral vasculature in the Chinese population.
Study Overview
Status
Unknown
Conditions
Detailed Description
Periodontitis has been demonstrated as a risk factor for ischaemic stroke in several clinical studies.
Atherosclerosis of the cerebral vasculatureis an important pathological process causing ischaemic stroke.
The investigator's study aims to investigate the relationship between tooth loss(used as a surrogate of periodontal disease) and atherosclerotic-related arterial stenosis in the Chinese population.
An estimated 1,000 participants that underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine between Apirl 2020 and January 2022 will be recruited in this trial.
Arterial stenosis features of each participants will be collected based on the results of digital subtraction angiography (DSA).
The missing teeth counts of each participant will be collected and some of them will recieved comprehensive periodontal examination.
Besides, blood samples will be collected in order to investigate the serum inflammatory markers(CRP,WBC,albumin,IL-6,IL-10).
The relationship between tooth loss and atherosclerotic-related arterial stenosis will be analysed by regression models adjusted for conventional risk factors (sex,age, obesity,smoking,Alcohol drinking,diabetes,hypertension,hyperuricaemia,hyperhomocysteinaemia)
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The relationship between atherosclerotic-related stenosis in different brain arteries and tooth loss categories
Time Frame: 1 day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The relationship between the severity of artery stenosis and tooth loss categories
Time Frame: 1 day
|
The degree of vascular stenosis will be categorized into five group: no stenosis, mild stenosis, moderate stenosis, severe stenosis and occlusion.
Ordinal logistic regression will be performed to analyse the relationship between the tooth loss categories and the degrees of artery stenosis.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2020
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
March 8, 2020
First Submitted That Met QC Criteria
March 10, 2020
First Posted (Actual)
March 11, 2020
Study Record Updates
Last Update Posted (Actual)
March 11, 2020
Last Update Submitted That Met QC Criteria
March 10, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZF2019-010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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