Periodontitis and Atherosclerotic-related Arterial Stenosis

Atherosclerosis of Artery Clinical Trial

Official title:

The Relationship Between Periodontitis and Atherosclerotic-related Arterial Stenosis in the Chinese Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04303351
• Other study ID #: ZF2019-010
• Status: Not yet recruiting
• Start date: April 2020
• Est. completion date: April 2022

Study information

• Verified date: March 2020
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Jianwen Guo, MD
• Phone: 13724899379
• Email: jianwen_guo[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: April 2022
• Est. primary completion date: March 2022
• Gender: All
• Age group: 18 Years to 98 Years

Eligibility

Inclusion Criteria:

1. subjects who underwent cerebral angiography at Guangdong Provincial Hospital of Chinese Medicine from April 2020 to December 2021

2. subjects who voluntarily participated in this study and provided informed consent.

Exclusion Criteria:

1. intracranial and extracranial artery stenosis caused by vascular inflammation, systemic connective tissue disease, and muscle fibre structure hypoplasia

2. inability to cooperate with the investigation

3. intracranial aneurysm and cerebral arteriovenous malformation confirmed by cerebral angiography

4. receipt of periodontal treatment in the previous 24 months.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of Artery
• Constriction, Pathologic
• Periodontitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The relationship between the severity of artery stenosis and tooth loss categories	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